N/A
N=33
Noninvasive Brain Stimulation in Mild Cognitive Impairment and Dementia
Alzheimer Disease · Mild Cognitive Impairment · Dementia
Bottom Line
View on ClinicalTrials.gov: NCT05270408 ↗Enrolled (actual)
33
Serious AEs
3.3%
Results posted
Mar 2025
Primary outcome: Primary: Change in Score on the Rey Auditory Verbal Learning Test (RAVLT) — 13.8; 17.8; 18.0; 13.4 T-score on a scale — p=0.25
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active Transcranial direct current stimulation (STARStim 8) (Device); Sham Transcranial direct current stimulation (STARStim 8) (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Score on the Rey Auditory Verbal Learning Test (RAVLT) |
13.8; 17.8; 18.0; 13.4; 21.0; 21.9 | 0.25 |
| SECONDARY Change in Score on the Brief Visuospatial Memory Test-Revised (BVMT-R) |
20.8; 24.2; 21.7; 22.8; 24.2; 21.1 | 0.98 |
| SECONDARY Change in Score on the Boston Naming Test Short Form |
30.6; 31.6; 30.1; 30.4; 31.5; 31.9 | 0.94 |
| SECONDARY Change in Score on the Delis Kaplan Executive Function System (DKEFS) Phonemic Fluency |
39.0; 37.5; 32.7; 33.6; 40.4; 35.9 | 0.06 |
| SECONDARY Change in Score on the Delis Kaplan Executive Function System (DKEFS) Semantic Fluency |
24.2; 28.1; 24.9; 25.0; 30.9; 22.8 | 0.61 |
| SECONDARY Change in Score on the Trail Making Test |
22.3; 31.3; 22.8; 28.0; 24.4; 20.6 | — |
| SECONDARY Change in Score on the Southwestern Assessment of Processing Speed |
27.6; 34.0; 26.1; 30.2; 31.0; 27.9 | 0.11 |
| SECONDARY Change in Score on the DKEFS Color-Word Interference Test |
35.5; 25.1; 35.0; 29.7; 30.3; 34.2 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Age 50 and older
- Fluent in English
- Active diagnosis of MCI or dementia
Exclusion Criteria
- 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 (NCT05270408). 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.