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Completed

NCT Number: NCT04504630

Noninvasive Brain Stimulation on Memory in Individuals With Mild Cognitive Impairment and History of Brain Injury

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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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 50 and older
  • Native English speakers
  • 12 years of education or higher
  • Active diagnosis of aMCI
  • History of TBI based on VA/DOD criteria

Exclusion criteria

  • TBI within the past 2 years
  • Lifetime history of stroke, transient ischemic attack, heart attack, or congestive heart failure
  • Lifetime history of epilepsy
  • Major psychiatric disorders (i.e., posttraumatic stress disorder, bipolar disorder, schizophrenia)
  • Substance use disorder
  • Has metal fragments in head
  • Taking medications that may interact with the HD-tDCS effect (i.e., amphetamines, L-dopa, carbamazepine, sulpiride, pergolide, lorazepam, dextromethorphan, D-cycloserine, flunarizine, or ropinirole)

Treatment and study plan

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).

Sham HD-tDCS

Device

Sham HD-tDCS

Primary outcomes

  1. Hopkins Verbal Learning Test-Revised Total Learning

    Time frame: Baseline, immediately following last HD-tDCS session, and again at 3-month follow-up

    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.

  2. Hopkins Verbal Learning Test-Revised Delayed Recall

    Time frame: Baseline, immediately following the last HD-tDCS session, and a 3-month follow-up

    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.

  3. Brief Visuospatial Memory Test-Revised (BVMT-R) Total Learning

    Time frame: Baseline, immediately post-treatment, and a 3 -month follow-up

    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.

  4. Brief Visuospatial Memory Test-Revised Delayed Recall

    Time frame: Baseline, immediately post-treatment, and a 3-month follow-up

    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.

Secondary outcomes

  1. Phonemic Fluency

    Time frame: Baseline, immediately post-treatment, and a 3-month follow-up

    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.

  2. Semantic Fluency

    Time frame: Baseline, immediate post-treatment, and a 3-month follow-up

    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.

  3. Trail Making Test

    Time frame: Baseline, immediate post-treatment, and a 3-month follow-up

    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. Stroop Color and Word Test

    Time frame: Baseline, immediate post-treatment, and a 3-month follow-up

    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.

  5. Digit Span Test

    Time frame: Baseline, immediate post-treatment, and a 3-month follow-up

    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

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • Congressionally Directed Medical Research Programs

Registry information

Official study title

High-Definition Transcranial Direct Current Stimulation on Episodic Memory in Individuals With Amnestic Mild Cognitive Impairment and History of TBI

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Aug 7, 2020
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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