N/A
N=26
Noninvasive Brain Stimulation on Memory in Individuals With Mild Cognitive Impairment and History of Brain Injury
Amnestic Mild Cognitive Impairment · Traumatic Brain Injury · Mild Traumatic Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT04504630 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Hopkins Verbal Learning Test-Revised Total Learning — 35.8; 35.9; 34.2; 31.6 T-score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- High Definition Transcranial Direct Current Stimulation (Device); Sham HD-tDCS (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hopkins Verbal Learning Test-Revised Total Learning |
35.8; 35.9; 34.2; 31.6; 32.7; 37.1 | — |
| PRIMARY Hopkins Verbal Learning Test-Revised Delayed Recall |
30.1; 31.0; 27.7; 26.9; 26.9; 32.4 | — |
| PRIMARY Brief Visuospatial Memory Test-Revised (BVMT-R) Total Learning |
33.0; 29.1; 32.3; 33.3; 33.8; 34.1 | — |
| PRIMARY Brief Visuospatial Memory Test-Revised Delayed Recall |
32.6; 32.4; 32.4; 32.0; 31.6; 32.4 | — |
| SECONDARY Phonemic Fluency |
45.8; 49.1; 46.3; 53.0; 49.1; 54.6 | — |
| SECONDARY Semantic Fluency |
38.4; 37.4; 38.6; 42.2; 37.3; 38.4 | — |
| SECONDARY Trail Making Test |
41.6; 41.9; 45.7; 44.1; 47.8; 39.1 | — |
| SECONDARY Stroop Color and Word Test |
38.8; 39.1; 41.6; 40.0; 39.9; 37.9 | — |
| SECONDARY Digit Span Test |
10.8; 9.8; 10.6; 10.4; 10.8; 9.4 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT04504630). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.