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Clinical Trials/NCT04504630
NCT04504630
Completed
Not Applicable

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

University of Texas Southwestern Medical Center1 site in 1 country26 target enrollmentDecember 5, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Amnestic Mild Cognitive Impairment
Sponsor
University of Texas Southwestern Medical Center
Enrollment
26
Locations
1
Primary Endpoint
Hopkins Verbal Learning Test-Revised Total Learning
Status
Completed
Last Updated
3 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
December 5, 2020
End Date
January 30, 2025
Last Updated
3 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Christian Lobue

Associate Professor

University of Texas Southwestern Medical Center

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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.

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.

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.

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

  • Phonemic Fluency(Baseline, immediately post-treatment, and a 3-month follow-up)
  • Semantic Fluency(Baseline, immediate post-treatment, and a 3-month follow-up)
  • Trail Making Test(Baseline, immediate post-treatment, and a 3-month follow-up)
  • Stroop Color and Word Test(Baseline, immediate post-treatment, and a 3-month follow-up)
  • Digit Span Test(Baseline, immediate post-treatment, and a 3-month follow-up)

Study Sites (1)

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