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| ID | Type | Description | Link |
|---|---|---|---|
| 4R00DC020185-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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The purpose of this study is to learn more about how brain stimulation affects word finding problems in people who have a traumatic brain injury (TBI). The type of brain stimulation used is called transcranial direct current stimulation (tDCS). tDCS delivers low levels of electric current to the brain and high definition tDCS (HD-tDCS) delivers the current with multiple electrodes on the scalp. This current is delivered with HD-tDCS to parts of the brain that may help with remembering things. The investigators hope that this can help to improve word finding and memory problems in people with TBI.
The investigators plan to recruit English-speaking participants aged 18-85 years with a history of chronic TBI (> 1 year since injury prior to enrollment), all of whom have problems with cognition. The participants will be randomized to receive (1) active first followed by sham HD-tDCS condition, or (2) sham first followed by active condition in order to assess the efficacy of HD-tDCS on improving verbal retrieval function. The randomization will be double-blinded to the participants and the research personnel who administer the procedures. The study therefore adopts a double-blind randomized cross-over design. The proposed study will measure response to HD-tDCS treatment over the pre-supplementary motor area (preSMA) region when compared to sham with verbal retrieval function (verbal fluency, naming, verbal learning) as the primary outcome. Secondary outcome measures include cognitive performance other than verbal retrieval function and electroencephalography (EEG) measures. The participants will receive two phases of 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA for 20 min) or sham across 2 weeks. All participants will be blinded to their condition. EEG and neuropsychological tasks will be completed at baseline, immediate follow-up after session 10, and a 2-month follow-up. The participants will also undergo an MRI session at baseline. Those participants randomized into the active or sham group will have the opportunity to return after 2 months and receive sham (if active first) or active (if sham first) treatment and will undergo the EEG and neuropsychological tests again immediately following the last HD-tDCS session and at a 2-month follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active to Sham Transcranial direct current stimulation | Experimental | Subjects in this arm will first be randomly assigned to receive active stimulation. After completion of active stimulation, subjects will be assigned to sham stimulation. |
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| Sham to Active transcranial direct current stimulation | Experimental | Subjects in this arm will first be randomly assigned to receive sham stimulation. After completion of sham stimulation, subjects will be assigned to active stimulation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Transcranial direct current stimulation | Device | Transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim 20 or 32. Stimulation will consist of 1 milliamp stimulation, with anodal stimulation delivered at electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, then remain at 1 milliamp of stimulation over 20 minutes, and finally ramping down at to 0 milliamps over 60 seconds. |
| Measure | Description | Time Frame |
|---|---|---|
| The Controlled Oral Word Association Test - letter fluency | Evaluation of treatment differences (active versus sham) in change on the Control Word Association Test. Metric: Number of Correct Items Generated | Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment. |
| The Controlled Oral Word Association Test - category fluency | Evaluation of treatment differences (active versus sham) in change on Category Fluency. Metric: Number of Correct Items Generated | Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment. |
| The Boston Naming Test | Evaluation of treatment differences (active versus sham) in change on The Boston Naming Test. Metric: Number of Correct Items Generated. | Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment. |
| The Delis Kaplan Color Word Interference Test | Evaluation of treatment differences (active versus sham) in change on the Delis Kaplan Color Word Interference Test. Metric: Time to Name Items | Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment. |
| Rey Auditory Verbal Learning Test and alternative lists | Evaluation of treatment differences (active versus sham) in change in Rey Auditory Verbal Learning Test. Metric: Number of Total learning items and Correct Recalls. | Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| The Trail Making Test (Parts A & B) | Evaluation of treatment differences (active versus sham) in change on the Trail Making Test (Parts A&B). Metric: Time to Solution | Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment. |
| Digit Span Forward & Backward |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Iris Hall, BS | Contact | 617-667-0289 | ihall1@bidmc.harvard.edu | |
| Hsueh-Sheng Chiang, MD, PhD | Contact | hchiang3@bidmc.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Hsueh-Sheng Chiang, MD, PhD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
Individual participant data (IPD) will be shared in a de-identified format in accordance with NIH data-sharing policies and institutional guidelines.
Data will be available after publication of primary results or 12 months following study completion, whichever occurs first. The data will be accessible for at least 5 years post-publication.
Qualified researchers may request access by submitting a data request with a description of the intended use.
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The participants will be randomly assigned to 1 of 2 treatment arms: (1) 1 milliamp transcranial direct current stimulation (tDCS) active treatment applied to pre-supplementary motor area for 20 minutes over 10 sessions to (2) sham tDCS following the same schedule.
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Participants, assessors, and technicians interacting with participants will be blind to assigned conditions.
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| Sham Transcranial direct current stimulation | Device | Sham transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim 20 or 32. The sham setup will consist of anodal electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, ramp down to 0 milliamps over 60 seconds and then be left off for 20 minutes. |
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Evaluation of treatment differences (active versus sham) in change in Digit Span Forward & Backward. Metric: Memory Span |
| Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment. |
| Rey-Osterrieth Complex Figure Test | Evaluation of treatment differences (active versus sham) in change in Rey-Osterrieth Complex Figure Test scores. Metric: Score | Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment. |
| The Digit Symbol Substitution Test | Evaluation of treatment differences (active versus sham) in change on the Digit Symbol Substitution Test. Metric: Number of Items | Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment. |
| Task-based electroencephalography (EEG) markers during a Go-NoGo task | Evaluation of treatment differences (active versus sham) in EEG change on a Go-NoGo task with different levels of perceptual/semantic complexity. Metric: event-related potentials and time frequency changes. | Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment. |
| Task-based electroencephalography (EEG) markers during a Semantic Object Memory Retrieval task | Evaluation of treatment differences (active versus sham) in EEG change on a Semantic Object Retrieval task. Metric: event-related potentials and time frequency changes. | Treatment differences (active versus sham) in change from Baseline to immediately and 2-months Post-Treatment. |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D000849 | Anomia |
| D019954 | Neurobehavioral Manifestations |
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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 |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
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