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In the present sham-controlled study, the investigators examine whether tDCS could be used to enhance language abilities (e.g., picture naming) in individuals with primary progressive aphasia (PPA) primarily characterized by difficulties with speech production.
Primary Progressive Aphasia (PPA) is a neurodegenerative condition characterized by insidious irreversible loss of language abilities. Prior studies suggest that transcranial direct current stimulation (tDCS) directed toward language areas of the brain may help to ameliorate symptoms of PPA. In the current study, the investigators are examining whether tDCS could be used to enhance language abilities (e.g., picture naming) in individuals with PPA variants primarily characterized by difficulties with speech production (non-fluent and logopenic). Participants are being recruited from the Penn Frontotemporal Dementia Center to receive 10 days of both real and sham tDCS (counter-balanced, full-crossover design; participants are naïve to stimulation condition). A battery of language tests are being administered at baseline, immediately post-tDCS (real and sham), and six weeks and twelve weeks following stimulation. Real tDCS may improve language performance in some individuals with PPA. Specifically, the investigators expect that tDCS will be more effective in people whose baseline performance is worse based on previous research. Severity of deficits at baseline may be an important factor in predicting which patients will respond positively to language-targeted tDCS therapies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real tDCS | Experimental | Transcranial direct current stimulation (tDCS) is a type of noninvasive brain stimulation that modulates the resting excitability of neuronal populations, thereby altering patterns of brain activity in potentially behaviorally relevant ways. The stimulation involves 20 minutes of constant stimulation at 1.5 mA. |
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| Sham tDCS | Sham Comparator | Sham tDCS uses identical stimulation parameters as the active condition, however terminates after 30 seconds in order to mimic the sensation of real tDCS. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial direct current stimulation | Device | Transcranial direct current stimulation (tDCS) is a type of noninvasive brain stimulation that modulates the resting excitability of neuronal populations, thereby altering patterns of brain activity in potentially behaviorally relevant ways. The stimulation involves 20 minutes of constant stimulation at 1.5 mA. |
| Measure | Description | Time Frame |
|---|---|---|
| Aphasia Severity (WAB-AQ): Effects of Active tDCS (Baseline vs. 0 Weeks Immediately Following Stimulation) | The Western Aphasia Battery (WAB) was administered at baseline and immediately post-tDCS (real; sham) following the termination of the tDCS session on the same day (0 week). We computed WAB-Aphasia Quotient (WAB-AQ), a measure of overall aphasia severity with higher scores indicating better language performance. The WAB assesses the following language domains in subtests: fluency, comprehension, repetition, and naming. We examined change in WAB-AQ and each of the sub-tests from baseline. Difference scores were computed by subtracting the post-intervention score (0 weeks) from baseline for each study arm to assess the impact of real/active vs sham tDCS on severity and each sub-test. Scale title: WAB-AQ; scale values: 0-100; higher scores=better outcome. | Difference in WAB-AQ from Baseline at 0-weeks Post-stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| Naming Ability (WAB Naming Subtest): Effects of Active tDCS Baseline vs. 0 Weeks Immediately Following Stimulation | WAB-naming subtest used common objects as stimuli. Participants were required to name the objects. Three-point maximum score could be earned for each stimulus and a total of 60-points could be earned on this task; points were deducted if the response was incorrect and required a cue or if the response included a paraphasia. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| H B Coslett, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28713256 | Derived | McConathey EM, White NC, Gervits F, Ash S, Coslett HB, Grossman M, Hamilton RH. Baseline Performance Predicts tDCS-Mediated Improvements in Language Symptoms in Primary Progressive Aphasia. Front Hum Neurosci. 2017 Jun 30;11:347. doi: 10.3389/fnhum.2017.00347. eCollection 2017. |
| Label | URL |
|---|---|
| Lab website | View source |
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16 participants were enrolled in the study. Subjects were enrolled if they were native English speakers, right handed, and received a diagnosis of primary progressive aphasia (PPA). Note that one participant was diagnosed as having PPA at the time of enrollment; however, it was later learned that this was a misdiagnosis and their data were not analyzed. Baseline Characteristics reported for N=13. The washout period between treatment arms was 12 weeks.
Recruitment period: 10/2017-11/2019. Patients with Primary Progressive Aphasia will be recruited from the clinical practices of Drs. H. Branch Coslett, Roy Hamilton, and Murray Grossman at the Hospital of the University of Pennsylvania. Additional recruitment measures involve flyers posted around the University of Pennsylvania campus and the Hospital of the University of Pennsylvania grounds, as well as online FTD/PPA support groups and in-person support groups around the Philadelphia area.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active tDCS, Then Sham tDCS | Transcranial direct current stimulation (tDCS) is a type of noninvasive brain stimulation that modulates the resting excitability of neuronal populations, thereby altering patterns of brain activity in potentially behaviorally relevant ways. The active stimulation involves 20 minutes of constant stimulation at 1.5 mA intensity. Following a washout period of 12 weeks after active tDCS in Arm 1, subjects then crossed over to treatment Arm 2, and received sham tDCS. |
| FG001 | Sham tDCS, Then Active tDCS | Sham tDCS uses identical stimulation parameters as the active condition, however terminates after 30 seconds in order to mimic the sensation of active tDCS. Following a washout period of 12 weeks after sham tDCS in Arm 1, subjects then crossed over to treatment Arm 2, and received active tDCS. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm 1 |
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| Arm 2 |
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Analyses were conducted on 13 of the 16 people enrolled in the study. Two participants were not included in analyses because they did not complete both arms of the study, and one person was excluded because they were misdiagnosed as having primary progressive aphasia.
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| ID | Title | Description |
|---|---|---|
| BG000 | Active tDCS, Then Sham | Transcranial direct current stimulation (tDCS) is a type of noninvasive brain stimulation that modulates the resting excitability of neuronal populations, thereby altering patterns of brain activity in potentially behaviorally relevant ways. The active stimulation condition involves 20 minutes of constant stimulation at 1.5 mA. Arm 1 data were collected prior to active tDCS, whereas Arm 2 data reflect performance 12 weeks following active tDCS (prior to crossing over to the sham tDCS treatment arm). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Aphasia Severity (WAB-AQ): Effects of Active tDCS (Baseline vs. 0 Weeks Immediately Following Stimulation) | The Western Aphasia Battery (WAB) was administered at baseline and immediately post-tDCS (real; sham) following the termination of the tDCS session on the same day (0 week). We computed WAB-Aphasia Quotient (WAB-AQ), a measure of overall aphasia severity with higher scores indicating better language performance. The WAB assesses the following language domains in subtests: fluency, comprehension, repetition, and naming. We examined change in WAB-AQ and each of the sub-tests from baseline. Difference scores were computed by subtracting the post-intervention score (0 weeks) from baseline for each study arm to assess the impact of real/active vs sham tDCS on severity and each sub-test. Scale title: WAB-AQ; scale values: 0-100; higher scores=better outcome. | Participants who completed both arms of the study to the 0-week follow-up (N=13). Of the 16 participants enrolled, 3 were excluded from the 0-week follow-up for the following reasons: withdrew prior to starting treatment arm 1 (n=2) and misdiagnosed as PPA (n=1). | Posted | Mean | Standard Deviation | score on a scale | Difference in WAB-AQ from Baseline at 0-weeks Post-stimulation |
2 years
Adverse events are reported to the PI and IRB within 24-48 hours of the initial event.
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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 | Active tDCS | Transcranial direct current stimulation (tDCS) is a type of noninvasive brain stimulation that modulates the resting excitability of neuronal populations, thereby altering patterns of brain activity in potentially behaviorally relevant ways. The active stimulation involves 20 minutes of constant stimulation at 1.5 mA intensity. |
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Withdrawal of two participants resulted in 14/16 who completed at least one treatment arm; additional participants were excluded due to not completing both treatment arms (N=2) and misdiagnosis (N=1). Data analyzed for N=13 participants for baseline to 0-week post-stimulation. One participant's second treatment arm was delayed by one week.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. H. Branch Coslett | University of Pennsylvania | 2156623606 | hbc@pennmedicine.upenn.edu |
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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 | May 2, 2019 | Mar 2, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D018888 | Aphasia, Primary Progressive |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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|
| Difference in WAB Naming Subtest from Baseline at 0-weeks Post-stimulation |
| NOT COMPLETED |
|
|
| BG001 | Sham tDCS, Then Active | Sham tDCS uses identical stimulation parameters as the active condition, however terminates after 30 seconds in order to mimic the sensation of real tDCS. Arm 1 data were collected prior to sham tDCS, whereas Arm 2 data reflect performance 12 weeks following sham tDCS (prior to crossing over to the active tDCS treatment arm). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Western Aphasia Battery - Aphasia Quotient (WAB-AQ) | The WAB-AQ is a weighted average of all subtest scores relating to spoken language, measuring language ability. It is a sum of all subtest scores from the first part of the WAB (Spontaneous speech, Auditory verbal comprehension, Repetition, Naming and word finding). We report the total average score and standard deviation. The total range is 0-100 (higher scores indicating better performance). | Mean | Standard Deviation | units on a scale |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Active tDCS, Then Sham tDCS | Transcranial direct current stimulation (tDCS) is a type of noninvasive brain stimulation that modulates the resting excitability of neuronal populations, thereby altering patterns of brain activity in potentially behaviorally relevant ways. The active stimulation involves 20 minutes of constant stimulation at 1.5 mA intensity. Following a washout period of 12 weeks after active tDCS in Arm 1, subjects then crossed over to treatment Arm 2, and received sham tDCS. |
| OG001 | Sham tDCS, Then Active tDCS | Sham tDCS uses identical stimulation parameters as the active condition, however terminates after 30 seconds in order to mimic the sensation of active tDCS. Following a washout period of 12 weeks after sham tDCS in Arm 1, subjects then crossed over to treatment Arm 2, and received active tDCS. |
|
|
|
| Secondary | Naming Ability (WAB Naming Subtest): Effects of Active tDCS Baseline vs. 0 Weeks Immediately Following Stimulation | WAB-naming subtest used common objects as stimuli. Participants were required to name the objects. Three-point maximum score could be earned for each stimulus and a total of 60-points could be earned on this task; points were deducted if the response was incorrect and required a cue or if the response included a paraphasia. | Participants who completed both arms of the study to the 0-week follow-up (N=13). Of the 16 participants enrolled, 3 were excluded from the 0-week follow-up for the following reasons: withdrew prior to starting treatment arm 1 (n=2) and misdiagnosed as PPA (n=1). | Posted | Mean | Standard Deviation | score on a scale | Difference in WAB Naming Subtest from Baseline at 0-weeks Post-stimulation |
|
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Sham tDCS | Sham tDCS uses identical stimulation parameters as the active condition, however terminates after 30 seconds in order to mimic the sensation of active tDCS. | 0 | 16 | 0 | 16 | 0 | 16 |
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| D001037 |
| Aphasia |
| 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 |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |