Cognitive Outcomes of Brain Stimulation As a Later-in-Life Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2025-06-03

Brief Summary

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This is a pilot study being done to attempt to improve episodic memory problems in persons with mild cognitive impairment (MCI) or dementia. The pre-supplemental motor area (preSMA) and dorsal anterior cingulate cortex (dACC) have been shown to play a role in episodic memory and language retrieval. Prior studies have suggested that neurostimulation targeting this region can improve episodic memory and word recall. 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 word retrieval and other cognitive functions in patients with MCI or dementia. Entraining the preSMA/dACC circuit with 10 sessions of HD-tDCS will allow us to study whether neurostimulation may be an effective treatment.

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Detailed Description

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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 word retrieval and other cognitive functions in patients with MCI or dementia after 10 sessions of HD-tDCS. There will be two treatment arms: active HD-tDCS (1 mA) and a sham group. For Phase 1, participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) or sham across 2 weeks. Word retrieval and other cognitive tasks will be completed at baseline, immediate follow-up after session 10, and a 2-month follow-up. For Phase 2, participants randomized into the sham group will have the opportunity to return after 2 months and receive the active treatment while being unblinded to their treatment condition. Following 10 active treatment sessions, word retrieval and other cognitive tasks will again be completed immediately following the last HD-tDCS session and then a 2-month follow-up.

Conditions

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Mild Cognitive Impairment Dementia Amnestic Mild Cognitive Impairment - aMCI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

In Phase 1, there will be two treatment arms (active and sham). All subjects will have the option to complete active stimulation of HD-tDCS. Those assigned to the sham condition group will have the option to return for active treatment in Phase 2. Each HD-tDCS condition is comprised of 10 days of active or sham stimulation targeting the pre-SMA (supplemental motor area)/sACC (subgenual anterior cingulate cortex) followed by neuropsychological testing after completion of the last session.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

The subjects will be informed that sham and active HD-tDCS will be used in the study, but they will be masked to condition in Phase 1. Aside from the PI, other study team members who perform assessments will be masked to HD-tDCS condition. Questionnaires will be completed examining how well the participants and outcomes assessors were blinded in Phase 1. During Phase 2, individuals who were assigned to the sham condition will be unblinded following all assessments as they will be given the option to return for the active condition. Study team members will become unblinded as a result.

Study Groups

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Phase 1: Active Treatment

Participants will receive 10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) across 2 weeks. Word retrieval and other cognitive tasks will be completed at baseline, immediate follow-up after session 10, and a 2-month follow-up

Group Type ACTIVE_COMPARATOR

NeuroElectric StarStim

Intervention Type DEVICE

10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) across 2 weeks

Phase 1: Sham Treatment

Participants will receive 10 sessions of sham stimulation across 2 weeks. Word retrieval and other cognitive tasks will be completed at baseline, immediate follow-up after session 10, and a 2-month follow-up

Group Type SHAM_COMPARATOR

Sham Treatment

Intervention Type DEVICE

Sham stimulation for 10 sessions over 2 weeks

Phase 2: Active Treatment

For Phase 2, participants randomized into the sham group will have the opportunity to return after 2 months from completing Phase 1. They will receive the active treatment while being unblinded to their treatment condition. Following 10 active treatment sessions, word retrieval and other cognitive tasks will again be completed immediately following the last HD-tDCS session and then a 2-month follow-up.

Group Type ACTIVE_COMPARATOR

NeuroElectric StarStim

Intervention Type DEVICE

10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) across 2 weeks

Interventions

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NeuroElectric StarStim

10 sessions of active stimulation (1 mA anodal HD-tDCS targeting preSMA/dACC for 20 min) across 2 weeks

Intervention Type DEVICE

Sham Treatment

Sham stimulation for 10 sessions over 2 weeks

Intervention Type DEVICE

Other Intervention Names

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Phase 1/2 Active

Eligibility Criteria

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Inclusion Criteria

Active diagnosis of mild cognitive impairment or dementia, Female and male subjects, All races/ethnicities, Age 55 years and older, Fluent in English,

Exclusion Criteria

Lifetime history of major neurologic syndromes (e.g., epilepsy, brain tumor, etc), Substance use disorder within the past year, Has metal fragments in skull/head, Current vision or hearing impairment that interferes with testing, Current medication use known to alter HD-tDCS reactivity

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No