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Noninvasive Brain Stimulation in Mild Cognitive Impairment and Dementia

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Completed

Conditions

Alzheimer Disease
Mild Cognitive Impairment
Dementia

Treatments

Device: Sham Transcranial direct current stimulation (STARStim 8)
Device: Active Transcranial direct current stimulation (STARStim 8)

Study type

Interventional

Funder types

Other

Identifiers

NCT05270408
STU-2021-0974

Details and patient eligibility

About

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.

Full 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.

Enrollment

34 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Age 50 and older
  2. Fluent in English
  3. Active diagnosis of MCI or dementia

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

34 participants in 3 patient groups

Active stimulation at 1mA
Experimental group
Description:
Participants will receive 1 mA active HD-tDCS for 20 minutes.
Treatment:
Device: Active Transcranial direct current stimulation (STARStim 8)
Device: Active Transcranial direct current stimulation (STARStim 8)
Active stimulation at 2mA
Experimental group
Description:
Participants will receive 2 mA active HD-tDCS for 20 minutes.
Treatment:
Device: Active Transcranial direct current stimulation (STARStim 8)
Device: Active Transcranial direct current stimulation (STARStim 8)
Sham group
Sham Comparator group
Description:
Participants will receive sham HD-tDCS for 20 minutes, meaning no stimulation.
Treatment:
Device: Sham Transcranial direct current stimulation (STARStim 8)

Trial contacts and locations

1

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Central trial contact

Stephanie Neaves, MA; Hannah Cabrera, MS

Data sourced from clinicaltrials.gov

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