Noninvasive Brain Stimulation in Mild Cognitive Impairment and Dementia

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-13

Study Completion Date

2024-02-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Alzheimer Disease Mild Cognitive Impairment Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Active stimulation at 1mA

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

Group Type EXPERIMENTAL

Active Transcranial direct current stimulation (STARStim 8)

Intervention Type 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 2mA

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

Group Type EXPERIMENTAL

Active Transcranial direct current stimulation (STARStim 8)

Intervention Type DEVICE

Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver 2mA to the scalp.

Sham group

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

Group Type SHAM_COMPARATOR

Sham Transcranial direct current stimulation (STARStim 8)

Intervention Type DEVICE

Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver no current to the scalp.

Interventions

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Active Transcranial direct current stimulation (STARStim 8)

Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver 1mA to the scalp.

Intervention Type DEVICE

Active Transcranial direct current stimulation (STARStim 8)

Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver 2mA to the scalp.

Intervention Type DEVICE

Sham Transcranial direct current stimulation (STARStim 8)

Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver no current to the scalp.

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No