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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-AZ190088 | Other Grant/Funding Number | CDMRP |
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| Name | Class |
|---|---|
| Congressionally Directed Medical Research Programs | FED |
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The study will examine the efficacy of high definition transcranial direct current stimulation (HD-tDCS) and its influence on episodic memory in patients with amnestic mild cognitive impairment and a history of Traumatic brain injury. Ten sessions of HD-tDCS to the dorsal anterior cingulate region is expected to result in improvements in episodic memory measures immediately following the last session and at a 3-month follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active HD-tDCS | Active Comparator | Participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting dorsal anterior cingulate region for 20 minutes) across 2 weeks, with episodic memory tasks completed at baseline, immediate follow-up after session 10, and a 3-month follow-up. |
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| Sham HD-tDCS | Sham Comparator | Participants will receive 10 sessions of sham stimulation across 2 weeks, with episodic memory tasks completed at baseline, immediate follow-up after session 10, and a 3-month follow-up. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Definition Transcranial Direct Current Stimulation | Device | This wireless device delivers a very low electrical current to focused regions on the scalp in order to modulate underlying brain circuits to promote neuroplasticity. The device will be fitted onto a neoprene EEG cap, with 1 anode electrode placed and surrounded by 4 cathode electrodes in a ring pattern. Electrical stimulation will be applied using a constant voltage cortical stimulator (Model D185, Digitimer Ltd, UK, maximal output 1000 V/1.5 A) with single square-wave 50-μs pulses (0.1 A/μs rise time). |
| Measure | Description | Time Frame |
|---|---|---|
| Hopkins Verbal Learning Test-Revised Total Learning | Episodic verbal memory will be assessed with the Hopkins Verbal Learning Test-Revised (HVLT-R). The HVLT-R is a verbal episodic memory task where a list of 12 words is read aloud for 3 consecutive trials followed by a 20 minute delayed recall trial. The number of items recalled immediately after each trial are summed to create a total learning score, ranging from 0-36. Also, the number of items recalled for the delayed trial are recorded as a delayed recall score, ranging from 0-12. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better episodic memory performance. | Baseline, immediately following last HD-tDCS session, and again at 3-month follow-up |
| Hopkins Verbal Learning Test-Revised Delayed Recall | Episodic verbal memory will be assessed with the Hopkins Verbal Learning Test-Revised (HVLT-R). The HVLT-R is a verbal episodic memory task where a list of 12 words is read aloud for 3 consecutive trials followed by a 20 minute delayed recall trial. The number of items recalled immediately after each trial are summed to create a total learning score, ranging from 0-36. Also, the number of items recalled for the delayed trial are recorded as a delayed recall score, ranging from 0-12. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better episodic memory performance. | Baseline, immediately following the last HD-tDCS session, and a 3-month follow-up |
| Brief Visuospatial Memory Test-Revised (BVMT-R) Total Learning | Episodic verbal memory will be assessed with the Brief Visuospatial Memory Test-Revised (BVMT-R). The BVMT-R is a visual episodic memory task where where an array of 6 simple geometric visual designs are presented in a 2 x 3 matrix for 10 seconds for 3 trials. The number of items recalled immediately after each trial are summed for accuracy and placement to create a total learning score, ranging from 0-36. Also, the number of items recalled for the delayed trial are recorded as a delayed recall score, ranging from 0-12. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better episodic memory performance. |
| Measure | Description | Time Frame |
|---|---|---|
| Phonemic Fluency | The phonemic verbal fluency task is a measure of language. The subject is required to name as many words as possible that begin with specified letters within 1 minute. Three different letter trials are completed. The outcome measure for this task is the total number of correct responses across the trials, ranging from 0-90. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
There is a plan to upload study data to the FITBIR repository system within one year of completion.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active HD-tDCS | Participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting dorsal anterior cingulate region for 20 minutes) across 2 weeks. |
| FG001 | Sham HD-tDCS |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Assigned to Treatment |
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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 | Mar 15, 2023 |
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| Sham HD-tDCS | Device | Sham HD-tDCS |
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| Baseline, immediately post-treatment, and a 3 -month follow-up |
| Brief Visuospatial Memory Test-Revised Delayed Recall | Episodic verbal memory will be assessed with the Brief Visuospatial Memory Test-Revised (BVMT-R). The BVMT-R is a visual episodic memory task where where an array of 6 simple geometric visual designs are presented in a 2 x 3 matrix for 10 seconds for 3 trials. The number of items recalled immediately after each trial are summed for accuracy and placement to create a total learning score, ranging from 0-36. Also, the number of items recalled for the delayed trial are recorded as a delayed recall score, ranging from 0-12. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better episodic memory performance. | Baseline, immediately post-treatment, and a 3-month follow-up |
| Baseline, immediately post-treatment, and a 3-month follow-up |
| Semantic Fluency | The semantic verbal fluency task is a measure of language and involves 3 conditions. The subject is required to name as many animals as possible within 1 minute. The outcome measure for this task is the total number of correct responses, ranging from 0-90. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance. | Baseline, immediate post-treatment, and a 3-month follow-up |
| Trail Making Test | The Trail Making Test is a measure of cognitive flexibility and executive functions. The task requires the subject to as quickly as possible complete two conditions, involving number sequencing and then number-letter switching. The outcome measure for this task is the time in seconds to complete the number-letter switching condition, ranging from 15-300. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance | Baseline, immediate post-treatment, and a 3-month follow-up |
| Stroop Color and Word Test | The Stroop Color and Word Test is a measure of information processing speed and complex attention. The task requires the subject to as quickly as possible complete 3 conditions, involving word reading, color naming, and response inhibition. The outcome measure for this task was the response inhibition trial, which is scored as the total correct items completed in the administration time of 45 seconds, ranging from 0-100. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance. | Baseline, immediate post-treatment, and a 3-month follow-up |
| Digit Span Test | The Wechsler Adult Intelligence Scale-4 Digit Span Test measures simple attention and working memory. The examiner reads aloud a series of numbers of increasing length, and individuals are required to repeat each series across 3 separate conditions, involving forwards, backwards, and in sequence. Each trial is scored as incorrect (0) or correct (1), and the total number of correct trials across the 3 conditions are summed, ranging from 0-48. Scores were converted to standardized scores (scaled-scores) using normative data, ranging from 1-19. Higher scores reflect better episodic memory performance | Baseline, immediate post-treatment, and a 3-month follow-up |
Participants will receive 10 sessions of sham stimulation across 2 weeks.
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| NOT COMPLETED |
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| Started Treatment |
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| Follow-Up at 3 Months |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active HD-tDCS | Participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting dorsal anterior cingulate region for 20 minutes) across 2 weeks. |
| BG001 | Sham HD-tDCS | Participants will receive 10 sessions of sham stimulation across 2 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| 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 | Standard Deviation | 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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| Time since diagnosis | Mean | Standard Deviation | years |
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| Education | Mean | Standard Deviation | 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 | Hopkins Verbal Learning Test-Revised Total Learning | Episodic verbal memory will be assessed with the Hopkins Verbal Learning Test-Revised (HVLT-R). The HVLT-R is a verbal episodic memory task where a list of 12 words is read aloud for 3 consecutive trials followed by a 20 minute delayed recall trial. The number of items recalled immediately after each trial are summed to create a total learning score, ranging from 0-36. Also, the number of items recalled for the delayed trial are recorded as a delayed recall score, ranging from 0-12. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better episodic memory performance. | 4 participants were lost to follow-up | Posted | Mean | Standard Deviation | T-score on a scale | Baseline, immediately following last HD-tDCS session, and again at 3-month follow-up |
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| Primary | Hopkins Verbal Learning Test-Revised Delayed Recall | Episodic verbal memory will be assessed with the Hopkins Verbal Learning Test-Revised (HVLT-R). The HVLT-R is a verbal episodic memory task where a list of 12 words is read aloud for 3 consecutive trials followed by a 20 minute delayed recall trial. The number of items recalled immediately after each trial are summed to create a total learning score, ranging from 0-36. Also, the number of items recalled for the delayed trial are recorded as a delayed recall score, ranging from 0-12. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better episodic memory performance. | 4 participants lost to follow-up | Posted | Mean | Standard Deviation | T-score on a scale | Baseline, immediately following the last HD-tDCS session, and a 3-month follow-up |
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| Primary | Brief Visuospatial Memory Test-Revised (BVMT-R) Total Learning | Episodic verbal memory will be assessed with the Brief Visuospatial Memory Test-Revised (BVMT-R). The BVMT-R is a visual episodic memory task where where an array of 6 simple geometric visual designs are presented in a 2 x 3 matrix for 10 seconds for 3 trials. The number of items recalled immediately after each trial are summed for accuracy and placement to create a total learning score, ranging from 0-36. Also, the number of items recalled for the delayed trial are recorded as a delayed recall score, ranging from 0-12. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better episodic memory performance. | 1 participant in active HD-tDCS group did not complete the BVMT-R immediately post-treatment. 4 participants were lost to follow-up. | Posted | Mean | Standard Deviation | T-score on a scale | Baseline, immediately post-treatment, and a 3 -month follow-up |
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| Primary | Brief Visuospatial Memory Test-Revised Delayed Recall | Episodic verbal memory will be assessed with the Brief Visuospatial Memory Test-Revised (BVMT-R). The BVMT-R is a visual episodic memory task where where an array of 6 simple geometric visual designs are presented in a 2 x 3 matrix for 10 seconds for 3 trials. The number of items recalled immediately after each trial are summed for accuracy and placement to create a total learning score, ranging from 0-36. Also, the number of items recalled for the delayed trial are recorded as a delayed recall score, ranging from 0-12. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better episodic memory performance. | 1 participant in active HD-tDCS group did not complete the BVMT-R immediately post-treatment. 4 participants were lost to follow-up. | Posted | Mean | Standard Deviation | T-score on a scale | Baseline, immediately post-treatment, and a 3-month follow-up |
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| Secondary | Phonemic Fluency | The phonemic verbal fluency task is a measure of language. The subject is required to name as many words as possible that begin with specified letters within 1 minute. Three different letter trials are completed. The outcome measure for this task is the total number of correct responses across the trials, ranging from 0-90. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance. | 4 participants were lost to follow-up. | Posted | Mean | Standard Deviation | T-score on a scale | Baseline, immediately post-treatment, and a 3-month follow-up |
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| Secondary | Semantic Fluency | The semantic verbal fluency task is a measure of language and involves 3 conditions. The subject is required to name as many animals as possible within 1 minute. The outcome measure for this task is the total number of correct responses, ranging from 0-90. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance. | 4 participants were lost to follow-up. | Posted | Mean | Standard Deviation | T-score on a scale | Baseline, immediate post-treatment, and a 3-month follow-up |
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| Secondary | Trail Making Test | The Trail Making Test is a measure of cognitive flexibility and executive functions. The task requires the subject to as quickly as possible complete two conditions, involving number sequencing and then number-letter switching. The outcome measure for this task is the time in seconds to complete the number-letter switching condition, ranging from 15-300. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance | 4 participants were lost to follow-up | Posted | Mean | Standard Deviation | T-score on a scale | Baseline, immediate post-treatment, and a 3-month follow-up |
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| Secondary | Stroop Color and Word Test | The Stroop Color and Word Test is a measure of information processing speed and complex attention. The task requires the subject to as quickly as possible complete 3 conditions, involving word reading, color naming, and response inhibition. The outcome measure for this task was the response inhibition trial, which is scored as the total correct items completed in the administration time of 45 seconds, ranging from 0-100. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance. | 4 participants were lost to follow-up | Posted | Mean | Standard Deviation | T-score on a scale | Baseline, immediate post-treatment, and a 3-month follow-up |
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| Secondary | Digit Span Test | The Wechsler Adult Intelligence Scale-4 Digit Span Test measures simple attention and working memory. The examiner reads aloud a series of numbers of increasing length, and individuals are required to repeat each series across 3 separate conditions, involving forwards, backwards, and in sequence. Each trial is scored as incorrect (0) or correct (1), and the total number of correct trials across the 3 conditions are summed, ranging from 0-48. Scores were converted to standardized scores (scaled-scores) using normative data, ranging from 1-19. Higher scores reflect better episodic memory performance | 1 participant did not complete the Digit Span Test in the active HD-tDCS group at the 3-month follow-up. 4 participants were lost to follow-up. | Posted | Mean | Standard Deviation | Scaled score on a scale | Baseline, immediate post-treatment, and a 3-month follow-up |
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Adverse events were monitored from the start of assigned treatments (1 mA and sham) through study completion. This involved collection of information about adverse effects daily at the beginning and end of each treatment session and then again at the 3-month follow-up visit.
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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 HD-tDCS | Participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting dorsal anterior cingulate region for 20 minutes) across 2 weeks. | 0 | 16 | 0 | 16 | 0 | 16 |
| EG001 | Sham HD-tDCS | Participants will receive 10 sessions of sham stimulation across 2 weeks. | 0 | 8 | 0 | 8 | 1 | 8 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea and Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christian LoBue, PhD | UT Southwestern Medical Center | 2146484658 | Christian.LoBue@utsw.edu |
| Apr 16, 2025 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 11, 2023 | Mar 11, 2025 | ICF_000.pdf |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D016489 | Head Injuries, Closed |
| D014949 | Wounds, Nonpenetrating |
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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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| Immediate Post-treatment |
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| 3 Month Follow-up |
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