Noninvasive Brain Stimulation in Mild Cognitive Impairment and Dementia

NCT05270408 | Completed Results FDA Device

• 1 other identifier: STU-2021-0974
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer Disease; Mild Cognitive Impairment; Dementia

Keywords

Transcranial direct current stimulation; Alzheimer Disease; Mild Cognitive Impairment; Dementia; MCI; Mild neurocognitive disorder; Amnestic; Pre- alzheimer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Change in Score on the Brief Visuospatial Memory Test-Revised (BVMT-R)

  Baseline, immediately following last treatment session, and 2-months post treatment

• Change in Score on the Boston Naming Test Short Form

  Baseline, immediately following last treatment session, and 2-months post treatment

• Change in Score on the Delis Kaplan Executive Function System (DKEFS) Phonemic Fluency

  Baseline, immediately following last treatment session, and 2-months post treatment

• Change in Score on the Delis Kaplan Executive Function System (DKEFS) Semantic Fluency

  Baseline, immediately following last treatment session, and 2-months post treatment

• Change in Score on the Trail Making Test

  Baseline, immediately following last treatment session, and 2-months post treatment

Study Arms (3)

Active stimulation at 1mA

EXPERIMENTAL

Participants will receive 1 mA active HD-tDCS for 20 minutes.

Device: Active Transcranial direct current stimulation (STARStim 8)

Active stimulation at 2mA

EXPERIMENTAL

Participants will receive 2 mA active HD-tDCS for 20 minutes.

Device: Active Transcranial direct current stimulation (STARStim 8)

Sham group

SHAM COMPARATOR

Participants will receive sham HD-tDCS for 20 minutes, meaning no stimulation.

Device: Sham Transcranial direct current stimulation (STARStim 8)

Interventions

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.

Active stimulation at 1mA

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.

Sham group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 50 and older
• Fluent in English
• Active diagnosis of MCI or dementia

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (1)

• 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.

  PMID: 39863318 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Dementia; Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Mental Disorders; Cognition Disorders

Results Point of Contact

• Title: Dr Christian LoBue
• Organization: UT Southwestern Medical Center

Christian.LoBue@utsouthwestern.edu

2146485265

Study Officials

• Christian LoBue, PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSISTANT PROFESSOR

Study Record Dates

• First Submitted: December 30, 2021
• First Posted: March 8, 2022
• Study Start: July 13, 2022
• Primary Completion: February 15, 2024
• Study Completion: February 15, 2024
• Last Updated: March 5, 2025
• Results First Posted: March 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)