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This study will investigate the effects of mild electrical stimulation in conjunction with speech therapy for people with post-stroke aphasia to enhance language recovery.
Aphasia is a disturbance of language, primarily caused by brain injury to the left cerebral hemisphere. Aphasia treatments include speech and language therapy and pharmacologic therapy, but several studies have found that these treatments are not completely effective for patients with aphasia, leaving them with residual deficits that significantly add to the cost of stroke-related care. Additionally, the amount and frequency of speech and language therapy delivered may have a critical effect on recovery. Therefore, there is a need for new treatments or adjuncts to existing treatments, such as brain stimulation interventions, that have the potential to show greater improvements in patients with aphasia. One such new approach for non-invasive brain stimulation is transcranial direct current stimulation (tDCS).
This study will examine the effects of tDCS during speech therapy to further examine which method or methods is best for patient recovery. Patients enrolled in the study will undergo language testing that covers a broad range of language functions. Functional Magnetic Resonance Imaging (fMRI) will be completed before and after speech therapy intervention arms to investigate the neural processes affected by tDCS and speech therapy.
Study design:
Patients will be randomly assigned to one of 2 speech therapy groups in a double-blind, partial crossover design. Patients will receive one of two different speech therapy treatment interventions to focus on specific processing deficits. Participants will undergo neuropsychological evaluation and fMRI assessment before receiving targeted or active-control anodal-tDCS for 10 therapy sessions. Participants will then be re-tested using the behavioral assessment measure and fMRI before crossing over to either receive the tDCS intervention they did not already receive, within the same speech therapy arm. They will complete a behavioral assessment and fMRI at 3 months post Treatment 2 and a final behavioral assessment at 6 months post Treatment 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Targeted tDCS with Phonologic-Focused Speech Therapy | Experimental | Participants will receive phonologic-focused speech therapy with targeted anodal-tDCS for 10 therapy sessions before. |
|
| Active Control tDCS with Phonologic-Focused Speech Therapy | Active Comparator | Participants will receive phonologic-focused speech therapy with active control tDCS for 10 therapy sessions. |
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| Targeted tDCS with Semantic-Focused Speech Therapy | Experimental | Participants will receive semantic-focused speech therapy with targeted anodal-tDCS for 10 therapy sessions. |
|
| Active Control tDCS with Semantic-Focused Speech Therapy | Active Comparator | Participants will receive semantic-focused speech therapy with active control tDCS for 10 therapy sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Targeted Transcranial Direct Current Stimulation | Device | High-Definition-tDCS will be delivered via a battery-driven constant direct current stimulator (Soterix) using a 4x1 montage (1 central anodal electrode and 4 cathodal electrodes) arranged in a HD-cap. The current is turned on and increased in a ramplike fashion over approximately 30 seconds until reaching a strength of no more than 2mA, with a current density equal to 0.08mA/cm2. Stimulation will be maintained no longer than 20 minutes, and stimulation will be applied to the targeted region. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | Improvement on trained, untrained and untested items used during therapy. Items will consist of words and pictures that participants will name. Percent correct on lists after each therapy cycle will be the primary behavioral outcome measure (items chosen were at baseline is 0% correct). There were 20 pictures and 20 words in each of the trained, untrained, and untested lists. Pictures were colored photographs. Cycle A is the speech therapy intervention given first, Cycle B is the speech therapy intervention given second Cycle A Trained and Untrained lists were assessed on the last day of therapy for Cycle A Cycle A Post Trained, Untrained and Untested lists were given during Behavioral Assessment 2, approximately 10-weeks post ending Cycle A. Cycle B Trained and Untrained lists were assessed on the last day of therapy for Cycle B Cycle B Post Trained, Untrained and Untested lists were given during Behavioral Assessment 3, approximately 10-weeks post ending Cycle A. | Upon the completion of therapy cycle (a cycle consists of 10 intervention days) and 10 weeks post |
| Measure | Description | Time Frame |
|---|---|---|
| fMRI- Baseline | Number of participants completing Rs-fMRI before therapy. | Baseline |
| fMRI After Cycle A | Number of participants completing Rs-fMRI after Cycle A therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Performance on Outcome Measures Assessed Through the Language Battery | A language battery screen assessing different language processes and providing an overall severity score (Quick Aphasia Battery or QAB) will be repeated three times (Time 1, Time 2, Time 3). Also outcomes on self-reported measures assessing confidence with speaking: Communicative Effectiveness Index (CETI), Communication Confidence Rating Scale for Aphasia (CCRSA) and overall symptoms of depression; Center for Epidemiologic Studies Short Depression Scale (CES-D-10). QAB = Total score range 0-10, higher scores mean less severe aphasia severity CETI= Total score range 1-100, higher scores mean better perceived communication confidence by an outside rater CCRSA = Total score range 0-100, higher scores mean more confidence in speaking ability CES-D-10= Total score range 0-30, scores >10 indicate symptoms of depression |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara Pillay, PhD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17102697 | Background | Jordan LC, Hillis AE. Disorders of speech and language: aphasia, apraxia and dysarthria. Curr Opin Neurol. 2006 Dec;19(6):580-5. doi: 10.1097/WCO.0b013e3280109260. | |
| 11687079 | Background | Greener J, Enderby P, Whurr R. Pharmacological treatment for aphasia following stroke. Cochrane Database Syst Rev. 2001;2001(4):CD000424. doi: 10.1002/14651858.CD000424. |
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After enrollment, participants underwent screening tests to ensure behavioral criteria was met. Of the 25 enrollments, 19 met behavioral criteria and were randomized into an arm. Those who did not meet behavioral criteria did not continue in the study.
Recruitment took place from August 5, 2019 through April 30, 2024 at a medical clinic and from an aphasia databank. The first participant was enrolled on December 13, 2019, and the last participant was enrolled August 11, 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phonologic-Focused Speech Therapy - Targeted tDCS First (A), Then Active Control tDCS (B) | Participants will receive phonologic-focused speech therapy with targeted anodal-tDCS for 10 therapy sessions before crossing over to receive Active Control tDCS for 10 sessions. Transcranial Direct Current Stimulation: High-Definition-tDCS will be delivered via a battery-driven constant direct current stimulator (Soterix) using a 4x1 montage (1 central anodal electrode and 4 cathodal electrodes) arranged in a HD-cap. The current is turned on and increased in a ramplike fashion over approximately 30 seconds until reaching a strength of no more than 2mA, with a current density equal to 0.08mA/cm2. Stimulation will be maintained no longer than 20 minutes. Stimulation is either applied to the targeted or active control region, depending on the therapy cycle. Phonologic-Focused Speech Therapy: Participants are asked to generate or choose from a list phonologic information about a target picture. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Behavioral Assessment 1 |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 5, 2024 |
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Partial crossover design. Participants will maintain one of two speech therapy modalities throughout the study, but will crossover from targeted to active control stimulation (or vice versa).
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Care provider, participant, and outcome assessor are masked for tDCS status.
|
|
| Active Control Transcranial Direct Current Stimulation | Device | High-Definition-tDCS will be delivered via a battery-driven constant direct current stimulator (Soterix) using a 4x1 montage (1 central anodal electrode and 4 cathodal electrodes) arranged in a HD-cap. The current is turned on and increased in a ramplike fashion over approximately 30 seconds until reaching a strength of no more than 2mA, with a current density equal to 0.08mA/cm2. Stimulation will be maintained no longer than 20 minutes, and stimulation will be applied to the active control region. |
|
|
| Phonologic-Focused Speech Therapy | Behavioral | Participants are asked to generate or choose from a list phonologic information about a target picture. |
|
|
| Semantic-Focused Speech Therapy | Behavioral | Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word. |
|
|
| 10-weeks post Cycle A |
| fMRI Post Cycle B | Number of participants completing fMRI post Cycle B | 10 weeks post cycle B |
| 3 time points: pre-assessment, 10 weeks post-therapy cycle A and 10 weeks post-therapy cycle B |
| 22592672 | Background | Brady MC, Kelly H, Godwin J, Enderby P. Speech and language therapy for aphasia following stroke. Cochrane Database Syst Rev. 2012 May 16;(5):CD000425. doi: 10.1002/14651858.CD000425.pub3. |
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| FG001 | Phonologic-Focused Speech Therapy - Active Control tDCS First (A), Then Targeted tDCS (B) | Participants will receive phonologic-focused speech therapy with active control tDCS for 10 therapy sessions before crossing over to receive target control tDCS for 10 therapy sessions. Transcranial Direct Current Stimulation: High-Definition-tDCS will be delivered via a battery-driven constant direct current stimulator (Soterix) using a 4x1 montage (1 central anodal electrode and 4 cathodal electrodes) arranged in a HD-cap. The current is turned on and increased in a ramplike fashion over approximately 30 seconds until reaching a strength of no more than 2mA, with a current density equal to 0.08mA/cm2. Stimulation will be maintained no longer than 20 minutes. Stimulation is either applied to the targeted or active control region, depending on the therapy cycle. Phonologic-Focused Speech Therapy: Participants are asked to generate or choose from a list phonologic information about a target picture. |
| FG002 | Semantic-Focused Speech Therapy - Targeted tDCS First (A), Then Active Control tDCS (B) | Participants will receive semantic-focused speech therapy with targeted anodal-tDCS for 10 therapy sessions before crossing over to receive active-control tDCS for 10 therapy sessions. Transcranial Direct Current Stimulation: High-Definition-tDCS will be delivered via a battery-driven constant direct current stimulator (Soterix) using a 4x1 montage (1 central anodal electrode and 4 cathodal electrodes) arranged in a HD-cap. The current is turned on and increased in a ramplike fashion over approximately 30 seconds until reaching a strength of no more than 2mA, with a current density equal to 0.08mA/cm2. Stimulation will be maintained no longer than 20 minutes. Stimulation is either applied to the targeted or active control region, depending on the therapy cycle. Semantic-Focused Speech Therapy: Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word. |
| FG003 | Semantic-Focused Speech Therapy Active Control tDCS First (A), Then Targeted tDCS (B) | Participants will receive semantic-focused speech therapy with active control tDCS for 10 therapy sessions before crossing over to receive targted tDCS for 10 therapy sessions. Transcranial Direct Current Stimulation: High-Definition-tDCS will be delivered via a battery-driven constant direct current stimulator (Soterix) using a 4x1 montage (1 central anodal electrode and 4 cathodal electrodes) arranged in a HD-cap. The current is turned on and increased in a ramplike fashion over approximately 30 seconds until reaching a strength of no more than 2mA, with a current density equal to 0.08mA/cm2. Stimulation will be maintained no longer than 20 minutes. Stimulation is either applied to the targeted or active control region, depending on the therapy cycle. Semantic-Focused Speech Therapy: Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word. |
| COMPLETED |
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| NOT COMPLETED |
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| FMRI Session 1 |
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| Therapy Cycle A |
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| Behavioral Assessment 2 |
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| FMRI Session 2 |
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| Therapy Cycle B |
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| Behavioral Assessment 3 |
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| FMRI Session 3 |
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| Behavioral Assessment 4 |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Phonologic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Phonologic-Focused Speech Therapy - Targeted tDCS first, then Active Control tDCS. Participants receive phonologic speech therapy for both cycles of speech therapy. They receive targeted tDCS first, then active control tDCS second. Phonologic-Focused Speech Therapy: Participants are asked to generate or choose from a list phonologic information about a target picture. |
| BG001 | Phonologic-Focused Speech Therapy - Active Control tDCS First, Then Targeted tDCS | Phonologic-Focused Speech Therapy - Active Control tDCS first, then Targeted tDCS Participants receive phonologic speech therapy for both cycles of speech therapy. They receive active control tDCS first, then targeted tDCS second. Phonologic-Focused Speech Therapy: Participants are asked to generate or choose from a list phonologic information about a target picture. |
| BG002 | Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Semantic-Focused Speech Therapy - Targeted tDCS first, then Active Control tDCS Participants receive semantic speech therapy for both cycles of speech therapy. They receive targeted tDCS first, then active control tDCS second. Semantic-Focused Speech Therapy: Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word. |
| BG003 | Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | Semantic-Focused Speech Therapy - Targeted tDCS first, then Active Control tDCS Participants receive semantic speech therapy for both cycles of speech therapy. They receive active control tDCS first, then targeted tDCS second. Semantic-Focused Speech Therapy: Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word. |
| BG004 | Total | Total of all reporting groups |
| 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, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Days Past Stroke Onset | Time from stroke onset to consenting. | Mean | Full Range | days |
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| Years of Education | Mean | Full Range | years |
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| 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 | Percent Correct on Picture Naming and Reading Tasks (Baseline on Items Was 0) | Improvement on trained, untrained and untested items used during therapy. Items will consist of words and pictures that participants will name. Percent correct on lists after each therapy cycle will be the primary behavioral outcome measure (items chosen were at baseline is 0% correct). There were 20 pictures and 20 words in each of the trained, untrained, and untested lists. Pictures were colored photographs. Cycle A is the speech therapy intervention given first, Cycle B is the speech therapy intervention given second Cycle A Trained and Untrained lists were assessed on the last day of therapy for Cycle A Cycle A Post Trained, Untrained and Untested lists were given during Behavioral Assessment 2, approximately 10-weeks post ending Cycle A. Cycle B Trained and Untrained lists were assessed on the last day of therapy for Cycle B Cycle B Post Trained, Untrained and Untested lists were given during Behavioral Assessment 3, approximately 10-weeks post ending Cycle A. | Cycle B participant analyzed is less than overall number to reflect participants who dropped out of the study part-way through | Posted | Mean | Standard Deviation | percentage of items correct | Upon the completion of therapy cycle (a cycle consists of 10 intervention days) and 10 weeks post |
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| Secondary | fMRI- Baseline | Number of participants completing Rs-fMRI before therapy. | Posted | Count of Participants | Participants | Baseline |
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| Secondary | fMRI After Cycle A | Number of participants completing Rs-fMRI after Cycle A therapy. | Posted | Count of Participants | Participants | 10-weeks post Cycle A |
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| Secondary | fMRI Post Cycle B | Number of participants completing fMRI post Cycle B | Posted | Count of Participants | Participants | 10 weeks post cycle B |
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| Other Pre-specified | Performance on Outcome Measures Assessed Through the Language Battery | A language battery screen assessing different language processes and providing an overall severity score (Quick Aphasia Battery or QAB) will be repeated three times (Time 1, Time 2, Time 3). Also outcomes on self-reported measures assessing confidence with speaking: Communicative Effectiveness Index (CETI), Communication Confidence Rating Scale for Aphasia (CCRSA) and overall symptoms of depression; Center for Epidemiologic Studies Short Depression Scale (CES-D-10). QAB = Total score range 0-10, higher scores mean less severe aphasia severity CETI= Total score range 1-100, higher scores mean better perceived communication confidence by an outside rater CCRSA = Total score range 0-100, higher scores mean more confidence in speaking ability CES-D-10= Total score range 0-30, scores >10 indicate symptoms of depression | Number below analyzed is different from overall number analyzed due to participants dropping out of study or self-report forms incomplete. | Posted | Mean | Standard Deviation | score on a scale | 3 time points: pre-assessment, 10 weeks post-therapy cycle A and 10 weeks post-therapy cycle B |
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Adverse event data were collected from the first day of intervention until up to six months after the last day of intervention.
Adverse event data were collected systematically on the last day of each treatment period.
Non-systematic adverse event data were also collected during a participant's study duration starting from the first study activity until up to 6 months post treatment 2.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phonologic-Focused Speech Therapy - Targeted tDCS | Phonologic-Focused Speech Therapy - Targeted tDCS Phonologic-Focused Speech Therapy: Participants are asked to generate or choose from a list phonologic information about a target picture. | 0 | 8 | 0 | 8 | 1 | 8 |
| EG001 | Phonologic-Focused Speech Therapy - Active Control tDCS | Phonologic-Focused Speech Therapy - Active Control tDCS Phonologic-Focused Speech Therapy: Participants are asked to generate or choose from a list phonologic information about a target picture. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | Semantic-Focused Speech Therapy - Targeted tDCS | Semantic-Focused Speech Therapy - Targeted tDCS Semantic-Focused Speech Therapy: Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word. | 0 | 8 | 0 | 8 | 3 | 8 |
| EG003 | Semantic-Focused Speech Therapy - Active Control tDCS | Semantic-Focused Speech Therapy Active Control tDCS Semantic-Focused Speech Therapy: Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word. | 0 | 7 | 0 | 7 | 2 | 7 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Non-systematic Assessment |
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| Skin Discomfort | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Discomfort at stimulation site |
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Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sara Pillay | Medical College of Wisconsin | 414-955-4482 | Sapillay@mcw.edu |
| Dec 18, 2024 |
| Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 25, 2021 | Sep 5, 2024 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| D001037 | Aphasia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
Not provided
Not provided
| Withdrawal by Subject |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| OG003 | Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | Semantic-Focused Speech Therapy Active Control tDCS first, then Targeted tDCS Semantic-Focused Speech Therapy: Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word. There are 10 speech therapy sessions in each cycle. |
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| OG003 | Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | Semantic-Focused Speech Therapy Active Control tDCS first, then Targeted tDCS Semantic-Focused Speech Therapy: Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word. There are 10 speech therapy sessions in each cycle. |
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| OG003 | Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | Semantic-Focused Speech Therapy Active Control tDCS first, then Targeted tDCS Semantic-Focused Speech Therapy: Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word. There are 10 speech therapy sessions in each cycle. |
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Phonologic-Focused Speech Therapy - Active Control tDCS first, then Targeted tDCS Phonologic-Focused Speech Therapy: Participants are asked to generate or choose from a list phonologic information about a target picture. |
| OG002 | Semantic-Focused Speech Therapy - Targeted tDCS First, Then Active Control tDCS | Semantic-Focused Speech Therapy - Targeted tDCS first, then Active Control tDCS Semantic-Focused Speech Therapy: Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word. |
| OG003 | Semantic-Focused Speech Therapy Active Control tDCS First, Then Targeted tDCS | Semantic-Focused Speech Therapy Active Control tDCS first, then Targeted tDCS Semantic-Focused Speech Therapy: Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word. |
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