Noninvasive Brain Stimulation in Mild Cognitive Impairment and Dementia

Last updated: February 27, 2025
Sponsor: University of Texas Southwestern Medical Center
Overall Status: Completed

Phase

N/A

Condition

Mild Cognitive Impairment

Memory Loss

Alzheimer's Disease

Treatment

Active Transcranial direct current stimulation (STARStim 8)

Sham Transcranial direct current stimulation (STARStim 8)

Clinical Study ID

NCT05270408
STU-2021-0974
  • Ages > 50
  • All Genders

Study 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

Inclusion Criteria:

  1. Age 50 and older

  2. Fluent in English

  3. Active diagnosis of MCI or dementia

Exclusion

Exclusion Criteria:

  1. Substance use disorder

  2. Has metal fragments in head

  3. 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)

Study Design

Total Participants: 33
Treatment Group(s): 2
Primary Treatment: Active Transcranial direct current stimulation (STARStim 8)
Phase:
Study Start date:
July 13, 2022
Estimated Completion Date:
February 15, 2024

Study Description

This is a pilot study being done to attempt to improve verbal episodic memory in persons with mild cognitive impairment (MCI) and dementia. Although the hippocampus is a brain structure most often associated with early deficits in MCI and dementia, the pre-supplemental motor area (preSMA) and dorsal anterior cingulate cortex (DACC) have been shown to play a role in verbal episodic memory for such patients. The purpose of this study is to examine the efficacy of high-definition transcranial direct current stimulation (HD-tDCS) to the preSMA/DACC region and its influence on verbal episodic memory in patients with MCI and dementia. Entraining the preSMA/DACC circuit with 10 sessions at one of two levels of HD-tDCS will allow the researchers to investigate whether neuromodulation may be used to improve verbal episodic memory. Participants will receive 10 sessions at one of two levels of active stimulation (1 mA or 2 mA anodal HD-tDCS targeting preSMA/DACC for 20 min) or sham across 2 weeks. The device is used to deliver high definition transcranial direct current stimulation to targeted regions. A verbal episodic memory task will be completed at baseline, immediately following the last HD-tDCS session, and a 2-month follow-up. The investigators plan to recruit English-speaking participants aged 50 years and older with MCI and dementia. Participants will be randomized into HD-tDCS conditions.

Connect with a study center

  • UT Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

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