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The research objective of this study is to examine the efficacy of HD-tDCS to the preSMA/DACC region and its influence on verbal episodic memory in patients with MCI or dementia after 10 sessions of HD-tDCS. There will be three treatment arms: two active HD-tDCS (1 mA or 2 mA) and a sham group. A verbal episodic memory task will be completed at baseline, immediately following the last HD-tDCS session, and a 2-month follow-up.
This is a pilot study being done to attempt to improve verbal episodic memory in persons with mild cognitive impairment (MCI) and dementia. Although the hippocampus is a brain structure most often associated with early deficits in MCI and dementia, the pre-supplemental motor area (preSMA) and dorsal anterior cingulate cortex (DACC) have been shown to play a role in verbal episodic memory for such patients. The purpose of this study is to examine the efficacy of high-definition transcranial direct current stimulation (HD-tDCS) to the preSMA/DACC region and its influence on verbal episodic memory in patients with MCI and dementia. Entraining the preSMA/DACC circuit with 10 sessions at one of two levels of HD-tDCS will allow the researchers to investigate whether neuromodulation may be used to improve verbal episodic memory. Participants will receive 10 sessions at one of two levels of active stimulation (1 mA or 2 mA anodal HD-tDCS targeting preSMA/DACC for 20 min) or sham across 2 weeks. The device is used to deliver high definition transcranial direct current stimulation to targeted regions. A verbal episodic memory task will be completed at baseline, immediately following the last HD-tDCS session, and a 2-month follow-up. The investigators plan to recruit English-speaking participants aged 50 years and older with MCI and dementia. Participants will be randomized into HD-tDCS conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active stimulation at 1mA | Experimental | Participants will receive 1 mA active HD-tDCS for 20 minutes. |
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| Active stimulation at 2mA | Experimental | Participants will receive 2 mA active HD-tDCS for 20 minutes. |
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| Sham group | Sham Comparator | Participants will receive sham HD-tDCS for 20 minutes, meaning no stimulation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Transcranial direct current stimulation (STARStim 8) | Device | Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver 1mA to the scalp. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Score on the Rey Auditory Verbal Learning Test (RAVLT) | The RAVLT is a verbal episodic memory task where a list of 15 words is read aloud for 5 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 0-75. Also, the number of items recalled for the delayed trial are recorded as a delayed recall score, ranging from 0-15. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better episodic memory performance. Changes from baseline for the total learning and delayed recall scores at the last HD-tDCS session and the 2-month follow-up will be measured as the primary outcomes. | Baseline, immediately following last treatment session, and 2-months post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Score on the Brief Visuospatial Memory Test-Revised (BVMT-R) | The BVMT-R is a visual episodic memory task where 6 simple designs are shown for 10 seconds in a 2 x 3 matrix for 3 learning trials followed by a 25-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 visual episodic memory performance. Changes from baseline for the total learning and delayed recall scores at the last HD-tDCS session and the 2-month follow-up will be measured. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian LoBue, PhD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39863318 | Derived | LoBue C, Chiang HS, Salter A, McClintock S, Nguyen TP, Logan R, Smernoff E, Pandya S, Hart J. High definition transcranial direct current stimulation as an intervention for cognitive deficits in Alzheimer's dementia: A randomized controlled trial. J Prev Alzheimers Dis. 2025 Feb;12(2):100023. doi: 10.1016/j.tjpad.2024.100023. Epub 2025 Jan 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham Group | Participants will receive sham HD-tDCS for 20 minutes, meaning no stimulation. Sham Transcranial direct current stimulation (STARStim 8): Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver no current to the scalp. |
| FG001 |
| 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 | Yes | No | No | Study Protocol | Apr 28, 2022 | Dec 10, 2024 |
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| Active Transcranial direct current stimulation (STARStim 8) | Device | Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver 2mA to the scalp. |
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| Sham Transcranial direct current stimulation (STARStim 8) | Device | Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver no current to the scalp. |
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| Baseline, immediately following last treatment session, and 2-months post treatment |
| Change in Score on the Boston Naming Test Short Form | The Boston Naming Test Short Form is a 30 item version of the task (odd and even item versions of the full test) and a measure of language. The subject is shown pictures of objects and is required to correctly name them as quickly as possible. The outcome measure for this task is the total number of correct responses, ranging from 0-30. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance. Changes from baseline to the last HD-tDCS session and the 2-month follow-up will be measured. | Baseline, immediately following last treatment session, and 2-months post treatment |
| Change in Score on the Delis Kaplan Executive Function System (DKEFS) Phonemic Fluency | The DKEFS 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. Changes from baseline to the last HD-tDCS session and the 2-month follow-up will be measured. | Baseline, immediately following last treatment session, and 2-months post treatment |
| Change in Score on the Delis Kaplan Executive Function System (DKEFS) Semantic Fluency | The DKEFS semantic verbal fluency task is a measure of language and involves 3 conditions. The subject is required to name as many animals and people names as possible within 1 minute. The outcome measure for this task is the total number of correct responses for both conditions combined, ranging from 0-90. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance. Changes from baseline to the last HD-tDCS session and the 2-month follow-up will be measured. | Baseline, immediately following last treatment session, and 2-months post treatment |
| Change in Score on the 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. Changes from baseline to the last HD-tDCS session and the 2-month follow-up will be measured. | Baseline, immediately following last treatment session, and 2-months post treatment |
| Change in Score on the Southwestern Assessment of Processing Speed | The Southwestern Assessment of Processing Speed is a measure of psychomotor processing speed. The subject is required to transcribe numbers to their corresponding written symbol as quickly as possible within 60 seconds. The outcome measure for this task is the total number of correct responses, ranging from 0-75. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance. Changes from baseline to the last HD-tDCS session and the 2-month follow-up will be measured. | Baseline, immediately following last treatment session, and 2-months post treatment |
| Change in Score on the DKEFS Color-Word Interference Test | The DKEFS Color-Word Interference test is a measure of information processing speed and complex attention. The task requires the subject to as quickly as possible complete four conditions, involving color naming, word reading, response inhibition, and then switching back-and-forth between two response patterns. The outcome measures for this task was the response inhibition trial and the switching trial, which are scored as the time in seconds to complete the conditions, ranging from 20-180. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance. Changes from baseline to the last HD-tDCS session and the 2-month follow-up will be measured. | Baseline, immediately following last treatment session, and 2-months post treatment |
| Active Stimulation at 1mA |
Participants will receive 1 mA active HD-tDCS for 20 minutes. Active Transcranial direct current stimulation (STARStim 8): Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver 1mA to the scalp. |
| FG002 | Active Stimulation at 2mA | Participants will receive 2 mA active HD-tDCS for 20 minutes. Active Transcranial direct current stimulation (STARStim 8): Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver 2mA to the scalp. |
| Assigned to Treatment With Mild Cognitive Impairment |
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| Assigned to Treatment With Alzheimer Dementia |
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| COMPLETED |
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| NOT COMPLETED |
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| Started Treatment |
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| Follow-Up at 2 Months |
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| Analysis - Primary Outcomes Available |
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Participants with mild cognitive impairment were not analyzed given the limited numbers that were recruited, allocated to treatment, and with data on outcome measures.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sham Group | sham HD-tDCS for 20 minutes, meaning no stimulation. |
| BG001 | Active Stimulation at 1mA | 1 mA active HD-tDCS for 20 minutes. |
| BG002 | Active Stimulation at 2mA | 2 mA active HD-tDCS for 20 minutes. |
| BG003 | 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, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Education | Mean | Standard Deviation | years |
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| Time since diagnosis | Data missing for 3 participants | 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 | Change in Score on the Rey Auditory Verbal Learning Test (RAVLT) | The RAVLT is a verbal episodic memory task where a list of 15 words is read aloud for 5 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 0-75. Also, the number of items recalled for the delayed trial are recorded as a delayed recall score, ranging from 0-15. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better episodic memory performance. Changes from baseline for the total learning and delayed recall scores at the last HD-tDCS session and the 2-month follow-up will be measured as the primary outcomes. | One participant lost to follow-up | Posted | Mean | Standard Deviation | T-score on a scale | Baseline, immediately following last treatment session, and 2-months post treatment |
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| Secondary | Change in Score on the Brief Visuospatial Memory Test-Revised (BVMT-R) | The BVMT-R is a visual episodic memory task where 6 simple designs are shown for 10 seconds in a 2 x 3 matrix for 3 learning trials followed by a 25-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 visual episodic memory performance. Changes from baseline for the total learning and delayed recall scores at the last HD-tDCS session and the 2-month follow-up will be measured. | One participant lost to follow-up | Posted | Mean | Standard Deviation | T-score on a scale | Baseline, immediately following last treatment session, and 2-months post treatment |
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| Secondary | Change in Score on the Boston Naming Test Short Form | The Boston Naming Test Short Form is a 30 item version of the task (odd and even item versions of the full test) and a measure of language. The subject is shown pictures of objects and is required to correctly name them as quickly as possible. The outcome measure for this task is the total number of correct responses, ranging from 0-30. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance. Changes from baseline to the last HD-tDCS session and the 2-month follow-up will be measured. | One participant lost to follow-up | Posted | Mean | Standard Deviation | T-score on a scale | Baseline, immediately following last treatment session, and 2-months post treatment |
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| Secondary | Change in Score on the Delis Kaplan Executive Function System (DKEFS) Phonemic Fluency | The DKEFS 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. Changes from baseline to the last HD-tDCS session and the 2-month follow-up will be measured. | One participant lost to follow-up | Posted | Mean | Standard Deviation | T-score on a scale | Baseline, immediately following last treatment session, and 2-months post treatment |
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| Secondary | Change in Score on the Delis Kaplan Executive Function System (DKEFS) Semantic Fluency | The DKEFS semantic verbal fluency task is a measure of language and involves 3 conditions. The subject is required to name as many animals and people names as possible within 1 minute. The outcome measure for this task is the total number of correct responses for both conditions combined, ranging from 0-90. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance. Changes from baseline to the last HD-tDCS session and the 2-month follow-up will be measured. | One participant lost to follow-up | Posted | Mean | Standard Deviation | T-score on a scale | Baseline, immediately following last treatment session, and 2-months post treatment |
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| Secondary | Change in Score on the 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. Changes from baseline to the last HD-tDCS session and the 2-month follow-up will be measured. | Several participants were unable to complete the test in the administration time due to the level of cognitive impairment. Thus, the test was discontinued for many participants, prohibiting scores to be derived for several in data analysis. Scores are therefore missing for these, and the number that was able to complete the test varied across conditions and time points. | Posted | Mean | Standard Deviation | T-score on a scale | Baseline, immediately following last treatment session, and 2-months post treatment |
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| Secondary | Change in Score on the Southwestern Assessment of Processing Speed | The Southwestern Assessment of Processing Speed is a measure of psychomotor processing speed. The subject is required to transcribe numbers to their corresponding written symbol as quickly as possible within 60 seconds. The outcome measure for this task is the total number of correct responses, ranging from 0-75. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance. Changes from baseline to the last HD-tDCS session and the 2-month follow-up will be measured. | One participant lost to follow-up. Data missing for this measure on one participant in active 2 mA group. | Posted | Mean | Standard Deviation | T-score on a scale | Baseline, immediately following last treatment session, and 2-months post treatment |
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| Secondary | Change in Score on the DKEFS Color-Word Interference Test | The DKEFS Color-Word Interference test is a measure of information processing speed and complex attention. The task requires the subject to as quickly as possible complete four conditions, involving color naming, word reading, response inhibition, and then switching back-and-forth between two response patterns. The outcome measures for this task was the response inhibition trial and the switching trial, which are scored as the time in seconds to complete the conditions, ranging from 20-180. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance. Changes from baseline to the last HD-tDCS session and the 2-month follow-up will be measured. | Several participants were unable to complete the test in the administration time due to the level of cognitive impairment. Thus, the test was discontinued for many participants, prohibiting scores to be derived for several in data analysis. Scores are therefore missing for these, and the number that was able to complete the test varied across conditions and time points. | Posted | Mean | Standard Deviation | T-score on a scale | Baseline, immediately following last treatment session, and 2-months post treatment |
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Adverse events were monitored from the start of assigned treatments (1 mA, 2 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 2-month 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 | Sham Group | sham HD-tDCS for 20 minutes, meaning no stimulation. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG001 | Active Stimulation at 1mA | 1 mA active HD-tDCS for 20 minutes. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG002 | Active Stimulation at 2mA | 2 mA active HD-tDCS for 20 minutes. | 0 | 13 | 1 | 13 | 0 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Cardiac disorders | Systematic Assessment | Patient with pre-existing cardiac condition discovered to have cardiac decline during a medical visit. Hospitalized and treated. Participant recovered well. Not considered related to the treatment protocol. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Christian LoBue | UT Southwestern Medical Center | 2146485265 | Christian.LoBue@utsouthwestern.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 8, 2024 | Dec 10, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| D003704 | Dementia |
| D019965 | Neurocognitive Disorders |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
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| RAVLT Total Learning Immediate post-treatment |
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| RAVLT Total Learning 2 months |
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| RAVLT Delayed Baseline |
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| RAVLT Delayed Immediate Post-treatment |
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| RAVLT Delayed 2 Months |
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| 0.18 |
| Cohen's d |
| 0.69 |
| 2-Sided |
| Superiority |
| RAVLT Delayed | ANCOVA | 0.48 | Cohen's d | 0.74 | 2-Sided | Superiority |
| RAVLT Delayed | ANCOVA | 0.64 | Cohen's d | 0.19 | 2-Sided | Superiority |
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| Units | Counts |
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| Units | Counts |
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| Participants |
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| OG002 | Active Stimulation at 2mA | Participants will receive 2 mA active HD-tDCS for 20 minutes. Active Transcranial direct current stimulation (STARStim 8): Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver 2mA to the scalp. |
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| Active Stimulation at 2mA |
2 mA active HD-tDCS for 20 minutes. |
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| Units | Counts |
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| Participants |
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| OG002 | Active Stimulation at 2mA | 2 mA active HD-tDCS for 20 minutes. |
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