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| Name | Class |
|---|---|
| University of South Carolina | OTHER |
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The investigators will study the effects of transcranial direct current (tDCS) stimulation during language therapy for naming in individuals with aphasia in the acute and subacute post stroke period. Naming difficulties are a persistent and common symptom in aphasia after left-hemisphere (LH) stroke. Behavioral therapy (speech and language therapy; SALT) is the mainstay treatment for post stroke aphasia. Transcranial direct cortical stimulation (tDCS) is a promising adjunct to traditional SALT. tDCS is a safe, non-invasive, non-painful electrical stimulation of the brain which modulates cortical excitability by application of weak electrical currents in the form of direct current brain polarization. It is usually administered via saline-soaked surface sponge electrodes attached to the scalp and connected to a direct current stimulator with low intensities. Most studies are conducted in the chronic phase after stroke. Because neuroplasticity is greatest early after stroke, there is reason to believe tDCS might be most effective in the acute-subacute period. However, only two studies have evaluated tDCS paired with language therapy in group studies of acute to subacute aphasic stroke patients and only one of these was sham-controlled. Furthermore, no studies (of which we are aware) have combined tDCS with therapy to facilitate naming in post stroke aphasia, as shown to be effective in studies of chronic stroke. In this study, the investigators will evaluate whether tDCS combined with SALT improves naming in individuals with aphasia in the acute and subacute post stroke period, more than SALT alone in a randomized, double-blind, sham-controlled trial. The investigators will test the hypothesis that anodal tDCS (A-tDCS) over a targeted region and computer-delivered SALT is associated with greater gains in accuracy in naming pictures, compared to sham combined with the same computer-delivered SALT in post stroke aphasia.
After informed consent is received, a neurological examination will be performed and multiple screening assessments will be conducted including a tDCS and MRI safety screening. If the participant passes the initial screening portion, speech and language diagnostic testing will be conducted during the same visit (Visit 1). During the next visit (Visit 2), participants will undergo a second baseline assessment of naming ability and assessment of connected speech. On that visit, participants who have no contraindication for MRI (and agree to have MRI) will be randomized to (1) functional magnetic resonance (fMRI) electrode placement or (2) structural electrode placement. All participants who have no contraindication will have structural and resting state functional connectivity MRI (rsfcMRI). Those randomized to fMRI electrode placement will also participate in the naming paradigm during the MRI. The third visit will include electrode positioning and tDCS treatment administration. Participants will receive 15 sessions (Visits 3-17) of tDCS + SALT administration. At the beginning of Visit 3, eligible participants will be randomized to receive either A-tDCS (1 milli amp (mA)) or sham-tDCS (placebo) for 15 sessions (20-minutes per each 45-minute behavioral treatment session) over the course of three weeks. A computer-delivered naming treatment will be coupled with the stimulation. The computer-delivered treatment task will be 45-minutes in total length, so that it will commence at the same time as the tDCS administration and continue for another 25-minutes after the tDCS has ceased. To assess cardiovascular arousal, blood pressure and heart rate will be measured before and after each session. Additionally, discomfort ratings will be recorded following the end of each session using the Wong-Baker FACES Pain Rating Scale and a weekly neurological exam will be administered by a neurologist. Neither the participant nor the clinician monitoring and setting up the treatment will have knowledge of the treatment condition (A-tDCS versus sham). Utilizing a computerized picture naming assessment, all participants will be assessed at several different time points throughout the experiment: twice immediately before and twice the week immediately following the fifteenth and final treatment session; twice at five weeks follow-up after the end of treatment; and twice at 20 weeks after the end of treatment. Participants who agree to participate in the MRI portion of the study (and have none of the additional exclusion criteria for MRI) will have structural and rsfcMRI at Visit 2, following the 15th treatment session (Week 1 after the end of treatment), and at 5 weeks after the end of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A-tDCS & SALT | Experimental | A-tDCS (1 mA) plus Speech and Language Treatment (SALT) for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. The electrical current will be administered to a pre-specified region of the brain. The stimulation will be delivered at an intensity of 1mA for a maximum of 20 minutes. SALT will be a computer-delivered naming + picture matching task . |
|
| Sham-tDCS & SALT | Sham Comparator | Sham-tDCS plus SALT for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. Current will be administered in a ramp-like fashion, but after the ramping, the intensity will drop to 0 mA. SALT will be a computer delivered oral naming + picture naming task. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A-tDCS (1 mA) | Device | 1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. A-tDCS stimulation will be active only in the first 20 minutes of the 45-minute treatment session. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Accuracy of Naming Untrained Pictures (Philadelphia Naming Test (PNT)) Pre-treatment to 1 Week Post-treatment | The purpose of this measure was to determine whether A-tDCS coupled with SALT will improve naming performance of participants with post stroke aphasia more effectively than SALT alone (i.e., the sham condition). The PNT is a 175-item picture naming test where a person earns one point per each correct answer. Scores range from 0-175 with higher scores associated with better performance. The outcome measure was the difference between the average of administrations on two consecutive days immediately before treatment and administrations on two consecutive days within 1 week after the end of treatment. | 2 consecutive days immediately before treatment and 2 consecutive days within 1 week after the end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Accuracy of Naming Untrained Pictures (Philadelphia Naming Test) Pre-treatment to 5-weeks Post-treatment | To determine whether A-tDCS coupled with SALT will improve naming performance of participants with post stroke aphasia for a greater duration than SALT alone (i.e., the sham condition). The PNT is a 175-item picture naming test where a person earns one point per each correct answer. Scores range from 0-175 with higher scores associated with better performance. |
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Inclusion Criteria:
Participants must satisfy the following inclusion criteria to be considered eligible for entry into this study:
Exclusion Criteria:
Participants with any of the following characteristics will not be eligible for entry into this study:
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| Name | Affiliation | Role |
|---|---|---|
| Argye B Hillis-Trupe, MD, MA | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38281579 | Derived | Kang JS, Bunker LD, Stockbridge MD, Hillis AE. White Matter Hyperintensities as a Predictor of Aphasia Recovery. Arch Phys Med Rehabil. 2024 Jun;105(6):1089-1098. doi: 10.1016/j.apmr.2024.01.008. Epub 2024 Jan 26. | |
| 37592860 | Derived | Stockbridge MD, Elm J, Teklehaimanot AA, Cassarly C, Spell LA, Fridriksson J, Hillis AE. Individual Differences in Response to Transcranial Direct Current Stimulation With Language Therapy in Subacute Stroke. Neurorehabil Neural Repair. 2023 Aug;37(8):519-529. doi: 10.1177/15459683231190642. Epub 2023 Aug 17. |
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Upon completion of the projects and dissemination of primary study results, the analysis data files will be made available to the public, along with the final version of the study protocol, the data dictionary, and brief instructions ("Read me" file). The public use data files and the accompanying documents will be made available through the National Technical Information Service (NTIS).
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| ID | Title | Description |
|---|---|---|
| FG000 | A-tDCS & SALT | A-tDCS (1 mA) plus Speech and Language Treatment (SALT) for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. The electrical current will be administered to a pre-specified region of the brain. The stimulation will be delivered at an intensity of 1mA for a maximum of 20 minutes. SALT will be a computer-delivered naming + picture matching task . A-tDCS (1 mA): 1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. A-tDCS stimulation will be active only in the first 20 minutes of the 45-minute treatment session. SALT: Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture. |
| FG001 | Sham-tDCS & SALT | Sham-tDCS plus SALT for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. Current will be administered in a ramp-like fashion, but after the ramping, the intensity will drop to 0 mA. SALT will be a computer delivered oral naming + picture naming task. SALT: Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture. Sham: 1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. Then, the current will be ramped back down to 0 mA in the sham condition. Termination of the stimulation after the ramping up process is generally undetectable, and the brief duration of stimulation yields no functional effects. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The primary analysis was conducted for the modified Intent-to-treat sample defined as all randomized participants for whom study treatment was initiated.
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| ID | Title | Description |
|---|---|---|
| BG000 | A-tDCS & SALT | A-tDCS (1 mA) plus Speech and Language Treatment (SALT) for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. The electrical current will be administered to a pre-specified region of the brain. The stimulation will be delivered at an intensity of 1mA for a maximum of 20 minutes. SALT will be a computer-delivered naming + picture matching task . A-tDCS (1 mA): 1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. A-tDCS stimulation will be active only in the first 20 minutes of the 45-minute treatment session. SALT: Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Accuracy of Naming Untrained Pictures (Philadelphia Naming Test (PNT)) Pre-treatment to 1 Week Post-treatment | The purpose of this measure was to determine whether A-tDCS coupled with SALT will improve naming performance of participants with post stroke aphasia more effectively than SALT alone (i.e., the sham condition). The PNT is a 175-item picture naming test where a person earns one point per each correct answer. Scores range from 0-175 with higher scores associated with better performance. The outcome measure was the difference between the average of administrations on two consecutive days immediately before treatment and administrations on two consecutive days within 1 week after the end of treatment. | The mITT=modified Intent-to-treat sample is defined as all randomized participants for whom study treatment was initiated (e.g. attended at least one treatment session), regardless of the treatment actually received. Participants were analyzed according to the group to which they were randomized. Missing data was imputed using multiple imputation. The primary analysis was adjusted for aphasia type (Anomia, Broca, or other type), baseline aphasia severity (AQ), and age. | Posted | Mean | 95% Confidence Interval | score on a scale | 2 consecutive days immediately before treatment and 2 consecutive days within 1 week after the end of treatment |
20 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A-tDCS & SALT | A-tDCS (1 mA) plus Speech and Language Treatment (SALT) for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. The electrical current will be administered to a pre-specified region of the brain. The stimulation will be delivered at an intensity of 1mA for a maximum of 20 minutes. SALT will be a computer-delivered naming + picture matching task . A-tDCS (1 mA): 1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. A-tDCS stimulation will be active only in the first 20 minutes of the 45-minute treatment session. SALT: Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebrovascular accident | Nervous system disorders | MedDRA 19 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site irritation | General disorders | MedDRA 19 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Argye Hillis, MD | Johns Hopkins University School of Medicine | 4109552228 | argye@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 2, 2021 | Aug 3, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 18, 2019 | Aug 3, 2022 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 14, 2019 | Aug 3, 2022 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D001037 | Aphasia |
| D007802 | Language |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| D012492 | Salts |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| SALT | Behavioral | Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture. |
|
|
| Sham | Device | 1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. Then, the current will be ramped back down to 0 mA in the sham condition. Termination of the stimulation after the ramping up process is generally undetectable, and the brief duration of stimulation yields no functional effects. |
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| The PNT will be administered at baseline and at 5 weeks post treatment. |
| Change in Content of Picture Description Pre-treatment to 1 Week Post-treatment | The investigators will also record the description of the "Cookie Theft" picture during administration of the National Institutes of Health Stroke Scale before and after treatment, and count the number of Content Units (CU) mentioned by healthy controls. This measure provides a sensitive measure of content of narrative speech in all levels of aphasia. Content Units are previously identified aspects of a picture that describe what is portrayed. The Cookie Theft picture includes 30 CUs on the left and 23 on the right combined into a single measure (the total). A person earns one point per each piece of content included. Scores range from 0-53 with higher scores associated with better performance. | Immediately before and within 1 week after treatment |
| Change in Efficiency of Picture Description Pre-treatment to 1 Week Post-treatment | The investigators determined the number of syllables/content unit (CU) in the Cookie Theft description, then calculated the difference between this performance pre-treatment and 1-week post-treatment. Syllables/CU provides a sensitive measure of efficiency of narrative speech in all levels of aphasia. Greater efficiency (fewer syllables required to convey a given amount of content) is associated with improvement in language. Content Units are previously identified aspects of a picture that describe what is portrayed. The Cookie Theft picture includes 30 CUs on the left and 23 on the right combined into a single measure (the total). A person earns one point per each piece of content included. Scores range from 0-53 with higher scores associated with better performance. A person who does not produce any language would have zero syllables, but there is no maximum number of syllables a person is allowed to produce in response to the task. | Immediately before and within 1 week after treatment |
| Change in Content of Picture Description Pre-treatment to 5 Weeks Post-treatment | The investigators will also record the description of the "Cookie Theft" picture during administration of the National Institutes of Health Stroke Scale before and after treatment, and count the number of Content Units (CU) mentioned by healthy controls. Content Units are previously identified aspects of a picture that describe what is portrayed. The Cookie Theft picture includes 30 CUs on the left and 23 on the right combined into a single measure (the total). A person earns one point per each piece of content included. Scores range from 0-53 with higher scores associated with better performance. | Immediately before and at 5 weeks after treatment |
| Change in Efficiency of Picture Description Pre-treatment to 5 Weeks Post-treatment | The investigators determined the number of syllables/content unit (CU) in the Cookie Theft description, then calculated the difference between this performance pre-treatment and 5-weeks post-treatment. Syllables/CU provides a sensitive measure of efficiency of narrative speech in all levels of aphasia. Greater efficiency (fewer syllables required to convey a given amount of content) is associated with improvement in language. Content Units are previously identified aspects of a picture that describe what is portrayed. The Cookie Theft picture includes 30 CUs on the left and 23 on the right combined into a single measure (the total). A person earns one point per each piece of content included. Scores range from 0-53 with higher scores associated with better performance. A person who does not produce any language would have zero syllables, but there is no maximum number of syllables a person is allowed to produce in response to the task. | Immediately before and at 5 weeks after treatment |
| Change in Stroke Impact Scale (SIS) Pre-treatment to Post-treatment | The SIS will be administered at baseline and within 1 week after treatment to evaluate changes in quality of life and social engagement. The SIS includes 59 aspects of post-stroke functioning. Participants rate each of the items on a scale from 5 (least encumbered, affected, or difficult) to 1 (most encumbered, affected or difficult). Ratings on each aspect are summed and then transformed to a 100-point scale using the following formula: Score = [(Actual raw score - lowest possible raw score) / Possible raw score range] x 100 The last item (#60) assesses the participant's overall perception of recovery and is presented in the form of a visual analog scale from 0 to 100, where 0 = "no recovery" and 100 = "full recovery." Total score is the average of all transformed scores and the overall perception of recovery. Total scores range from 0-100, with higher scores associated with better recovery. | Immediately before and within 1 week after treatment |
| Change in Stroke Impact Scale (SIS) Pre-treatment to 5 Weeks Post-treatment | The SIS was administered at baseline and 5 weeks after treatment to evaluate any lasting changes in quality of life and social engagement. The SIS includes 59 aspects of post-stroke functioning. Participants rate each of the items on a scale from 5 (least encumbered, affected, or difficult) to 1 (most encumbered, affected or difficult). Ratings on each aspect are summed and then transformed to a 100-point scale using the following formula: Score = [(Actual raw score - lowest possible raw score) / Possible raw score range] x 100 The last item (#60) assesses the participant's overall perception of recovery and is presented in the form of a visual analog scale from 0 to 100, where 0 = "no recovery" and 100 = "full recovery." Total score is the average of all transformed scores and the overall perception of recovery. Total scores range from 0-100, with higher scores associated with better recovery. | Immediately before and 5 weeks after treatment |
| Change in Accuracy of Naming Untrained Pictures (Philadelphia Naming Test) Pre-treatment to 20-weeks Post-treatment | To determine whether A-tDCS coupled with SALT will improve naming performance of participants with post stroke aphasia for a greater duration than SALT alone (i.e., the sham condition). The PNT is a 175-item picture naming test where a person earns one point per each correct answer. Scores range from 0-175 with higher scores associated with better performance. | The PNT will be administered at baseline and at 20 weeks post treatment. |
| Change in Content of Picture Description Pre-treatment to 20-weeks Post-treatment | The investigators will also record the description of the "Cookie Theft" picture during administration of the National Institutes of Health Stroke Scale before and after treatment, and count the number of Content Units (CU) mentioned by healthy controls. Content Units are previously identified aspects of a picture that describe what is portrayed. The Cookie Theft picture includes 30 CUs on the left and 23 on the right combined into a single measure (the total). A person earns one point per each piece of content included. Scores range from 0-53 with higher scores associated with better performance. | Immediately before and at 20 weeks after treatment |
| Change in the Efficiency of Picture Description Pre-treatment to 20 Weeks Post-treatment | The investigators determined the number of syllables/content unit (CU) in the Cookie Theft description, then calculated the difference between this performance pre-treatment and 20-weeks post-treatment. Syllables/CU provides a sensitive measure of efficiency of narrative speech in all levels of aphasia. Greater efficiency (fewer syllables required to convey a given amount of content) is associated with improvement in language. Content Units are previously identified aspects of a picture that describe what is portrayed. The Cookie Theft picture includes 30 CUs on the left and 23 on the right combined into a single measure (the total). A person earns one point per each piece of content included. Scores range from 0-53 with higher scores associated with better performance. A person who does not produce any language would have zero syllables, but there is no maximum number of syllables a person is allowed to produce in response to the task. | Immediately before and at 20 weeks after treatment |
| Change in Stroke Impact Scale (SIS) Pre-treatment to 20 Weeks Post-treatment | The SIS was administered at baseline and 20 weeks after treatment to evaluate any lasting changes in quality of life and social engagement. The SIS includes 59 aspects of post-stroke functioning. Participants rate each of the items on a scale from 5 (least encumbered, affected, or difficult) to 1 (most encumbered, affected or difficult). Ratings on each aspect are summed and then transformed to a 100-point scale using the following formula: Score = [(Actual raw score - lowest possible raw score) / Possible raw score range] x 100 The last item (#60) assesses the participant's overall perception of recovery and is presented in the form of a visual analog scale from 0 to 100, where 0 = "no recovery" and 100 = "full recovery." Total score is the average of all transformed scores and the overall perception of recovery. Total scores range from 0-100, with higher scores associated with better recovery. | Immediately before and 20 weeks after treatment |
| 36912144 | Derived | Stockbridge MD, Elm J, Breining BL, Tippett DC, Sebastian R, Cassarly C, Teklehaimanot A, Spell LA, Sheppard SM, Vitti E, Ruch K, Goldberg EB, Kelly C, Keator LM, Fridriksson J, Hillis AE. Transcranial Direct-Current Stimulation in Subacute Aphasia: A Randomized Controlled Trial. Stroke. 2023 Apr;54(4):912-920. doi: 10.1161/STROKEAHA.122.041557. Epub 2023 Mar 13. |
| BG001 | Sham-tDCS & SALT | Sham-tDCS plus SALT for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. Current will be administered in a ramp-like fashion, but after the ramping, the intensity will drop to 0 mA. SALT will be a computer delivered oral naming + picture naming task. SALT: Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture. Sham: 1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. Then, the current will be ramped back down to 0 mA in the sham condition. Termination of the stimulation after the ramping up process is generally undetectable, and the brief duration of stimulation yields no functional effects. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Participants could indicate multiple race/ethnicities | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Western Aphasia Battery Aphasia Quotient | The scores range from 0-100. Higher scores are associated with better language. | Median | Inter-Quartile Range | units on a scale |
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| NIH Stroke Scale | The scale ranges from 0-42 with lower scores being better. A score of 0 indicates no stroke symptoms. A score of 42 indicates severe stroke. | Median | Inter-Quartile Range | units on a scale |
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| Secondary | Change in Accuracy of Naming Untrained Pictures (Philadelphia Naming Test) Pre-treatment to 5-weeks Post-treatment | To determine whether A-tDCS coupled with SALT will improve naming performance of participants with post stroke aphasia for a greater duration than SALT alone (i.e., the sham condition). The PNT is a 175-item picture naming test where a person earns one point per each correct answer. Scores range from 0-175 with higher scores associated with better performance. | Completers sample. Missing data is not imputed. Data was missing for 6 participants. | Posted | Mean | 95% Confidence Interval | score on a scale | The PNT will be administered at baseline and at 5 weeks post treatment. |
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| Secondary | Change in Content of Picture Description Pre-treatment to 1 Week Post-treatment | The investigators will also record the description of the "Cookie Theft" picture during administration of the National Institutes of Health Stroke Scale before and after treatment, and count the number of Content Units (CU) mentioned by healthy controls. This measure provides a sensitive measure of content of narrative speech in all levels of aphasia. Content Units are previously identified aspects of a picture that describe what is portrayed. The Cookie Theft picture includes 30 CUs on the left and 23 on the right combined into a single measure (the total). A person earns one point per each piece of content included. Scores range from 0-53 with higher scores associated with better performance. | Completers sample. Missing data is not imputed. The data was missing for 9 patients. | Posted | Mean | 95% Confidence Interval | units on a scale | Immediately before and within 1 week after treatment |
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| Secondary | Change in Efficiency of Picture Description Pre-treatment to 1 Week Post-treatment | The investigators determined the number of syllables/content unit (CU) in the Cookie Theft description, then calculated the difference between this performance pre-treatment and 1-week post-treatment. Syllables/CU provides a sensitive measure of efficiency of narrative speech in all levels of aphasia. Greater efficiency (fewer syllables required to convey a given amount of content) is associated with improvement in language. Content Units are previously identified aspects of a picture that describe what is portrayed. The Cookie Theft picture includes 30 CUs on the left and 23 on the right combined into a single measure (the total). A person earns one point per each piece of content included. Scores range from 0-53 with higher scores associated with better performance. A person who does not produce any language would have zero syllables, but there is no maximum number of syllables a person is allowed to produce in response to the task. | Completers sample. Missing data is not imputed. The data was missing for 9 patients. | Posted | Mean | 95% Confidence Interval | units on a scale | Immediately before and within 1 week after treatment |
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| Secondary | Change in Content of Picture Description Pre-treatment to 5 Weeks Post-treatment | The investigators will also record the description of the "Cookie Theft" picture during administration of the National Institutes of Health Stroke Scale before and after treatment, and count the number of Content Units (CU) mentioned by healthy controls. Content Units are previously identified aspects of a picture that describe what is portrayed. The Cookie Theft picture includes 30 CUs on the left and 23 on the right combined into a single measure (the total). A person earns one point per each piece of content included. Scores range from 0-53 with higher scores associated with better performance. | Completers sample. Missing data is not imputed. The data was missing for 10 patients. | Posted | Mean | 95% Confidence Interval | units on a scale | Immediately before and at 5 weeks after treatment |
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| Secondary | Change in Efficiency of Picture Description Pre-treatment to 5 Weeks Post-treatment | The investigators determined the number of syllables/content unit (CU) in the Cookie Theft description, then calculated the difference between this performance pre-treatment and 5-weeks post-treatment. Syllables/CU provides a sensitive measure of efficiency of narrative speech in all levels of aphasia. Greater efficiency (fewer syllables required to convey a given amount of content) is associated with improvement in language. Content Units are previously identified aspects of a picture that describe what is portrayed. The Cookie Theft picture includes 30 CUs on the left and 23 on the right combined into a single measure (the total). A person earns one point per each piece of content included. Scores range from 0-53 with higher scores associated with better performance. A person who does not produce any language would have zero syllables, but there is no maximum number of syllables a person is allowed to produce in response to the task. | Completers sample. Missing data is not imputed. The data was missing for 10 patients. | Posted | Mean | 95% Confidence Interval | units on a scale | Immediately before and at 5 weeks after treatment |
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| Secondary | Change in Stroke Impact Scale (SIS) Pre-treatment to Post-treatment | The SIS will be administered at baseline and within 1 week after treatment to evaluate changes in quality of life and social engagement. The SIS includes 59 aspects of post-stroke functioning. Participants rate each of the items on a scale from 5 (least encumbered, affected, or difficult) to 1 (most encumbered, affected or difficult). Ratings on each aspect are summed and then transformed to a 100-point scale using the following formula: Score = [(Actual raw score - lowest possible raw score) / Possible raw score range] x 100 The last item (#60) assesses the participant's overall perception of recovery and is presented in the form of a visual analog scale from 0 to 100, where 0 = "no recovery" and 100 = "full recovery." Total score is the average of all transformed scores and the overall perception of recovery. Total scores range from 0-100, with higher scores associated with better recovery. | Completers sample. Missing data is not imputed. The data was missing for 9 patients. | Posted | Mean | 95% Confidence Interval | units on a scale | Immediately before and within 1 week after treatment |
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| Secondary | Change in Stroke Impact Scale (SIS) Pre-treatment to 5 Weeks Post-treatment | The SIS was administered at baseline and 5 weeks after treatment to evaluate any lasting changes in quality of life and social engagement. The SIS includes 59 aspects of post-stroke functioning. Participants rate each of the items on a scale from 5 (least encumbered, affected, or difficult) to 1 (most encumbered, affected or difficult). Ratings on each aspect are summed and then transformed to a 100-point scale using the following formula: Score = [(Actual raw score - lowest possible raw score) / Possible raw score range] x 100 The last item (#60) assesses the participant's overall perception of recovery and is presented in the form of a visual analog scale from 0 to 100, where 0 = "no recovery" and 100 = "full recovery." Total score is the average of all transformed scores and the overall perception of recovery. Total scores range from 0-100, with higher scores associated with better recovery. | Completers sample. Missing data is not imputed. The data was missing for 10 patients. | Posted | Mean | 95% Confidence Interval | units on a scale | Immediately before and 5 weeks after treatment |
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| Secondary | Change in Accuracy of Naming Untrained Pictures (Philadelphia Naming Test) Pre-treatment to 20-weeks Post-treatment | To determine whether A-tDCS coupled with SALT will improve naming performance of participants with post stroke aphasia for a greater duration than SALT alone (i.e., the sham condition). The PNT is a 175-item picture naming test where a person earns one point per each correct answer. Scores range from 0-175 with higher scores associated with better performance. | Completers sample. Missing data is not imputed. The data was missing for 6 patients. | Posted | Mean | 95% Confidence Interval | score on a scale | The PNT will be administered at baseline and at 20 weeks post treatment. |
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| Secondary | Change in Content of Picture Description Pre-treatment to 20-weeks Post-treatment | The investigators will also record the description of the "Cookie Theft" picture during administration of the National Institutes of Health Stroke Scale before and after treatment, and count the number of Content Units (CU) mentioned by healthy controls. Content Units are previously identified aspects of a picture that describe what is portrayed. The Cookie Theft picture includes 30 CUs on the left and 23 on the right combined into a single measure (the total). A person earns one point per each piece of content included. Scores range from 0-53 with higher scores associated with better performance. | Completers sample. Missing data is not imputed. The data was missing for 10 patients. | Posted | Mean | 95% Confidence Interval | units on a scale | Immediately before and at 20 weeks after treatment |
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| Secondary | Change in the Efficiency of Picture Description Pre-treatment to 20 Weeks Post-treatment | The investigators determined the number of syllables/content unit (CU) in the Cookie Theft description, then calculated the difference between this performance pre-treatment and 20-weeks post-treatment. Syllables/CU provides a sensitive measure of efficiency of narrative speech in all levels of aphasia. Greater efficiency (fewer syllables required to convey a given amount of content) is associated with improvement in language. Content Units are previously identified aspects of a picture that describe what is portrayed. The Cookie Theft picture includes 30 CUs on the left and 23 on the right combined into a single measure (the total). A person earns one point per each piece of content included. Scores range from 0-53 with higher scores associated with better performance. A person who does not produce any language would have zero syllables, but there is no maximum number of syllables a person is allowed to produce in response to the task. | Completers sample. Missing data is not imputed. The data was missing for 10 patients. | Posted | Mean | 95% Confidence Interval | units on a scale | Immediately before and at 20 weeks after treatment |
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| Secondary | Change in Stroke Impact Scale (SIS) Pre-treatment to 20 Weeks Post-treatment | The SIS was administered at baseline and 20 weeks after treatment to evaluate any lasting changes in quality of life and social engagement. The SIS includes 59 aspects of post-stroke functioning. Participants rate each of the items on a scale from 5 (least encumbered, affected, or difficult) to 1 (most encumbered, affected or difficult). Ratings on each aspect are summed and then transformed to a 100-point scale using the following formula: Score = [(Actual raw score - lowest possible raw score) / Possible raw score range] x 100 The last item (#60) assesses the participant's overall perception of recovery and is presented in the form of a visual analog scale from 0 to 100, where 0 = "no recovery" and 100 = "full recovery." Total score is the average of all transformed scores and the overall perception of recovery. Total scores range from 0-100, with higher scores associated with better recovery. | Completers sample. Missing data is not imputed. The data was missing for 10 patients. | Posted | Mean | 95% Confidence Interval | score on a scale | Immediately before and 20 weeks after treatment |
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| 1 |
| 26 |
| 2 |
| 26 |
| 5 |
| 26 |
| EG001 | Sham-tDCS & SALT | Sham-tDCS plus SALT for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. Current will be administered in a ramp-like fashion, but after the ramping, the intensity will drop to 0 mA. SALT will be a computer delivered oral naming + picture naming task. SALT: Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture. Sham: 1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. Then, the current will be ramped back down to 0 mA in the sham condition. Termination of the stimulation after the ramping up process is generally undetectable, and the brief duration of stimulation yields no functional effects. | 0 | 25 | 2 | 25 | 1 | 25 |
| Confusional state | Psychiatric disorders | MedDRA 19 | Systematic Assessment |
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| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 19 | Systematic Assessment |
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| Diplopia | Eye disorders | MedDRA 19 | Systematic Assessment |
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| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 19 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 19 | Systematic Assessment |
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Not provided
Not provided
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003142 | Communication |
| D001519 | Behavior |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| D007287 | Inorganic Chemicals |