Stimulation to Improve Memory

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

269 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2024-12-19

Brief Summary

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This study will test the effects of different doses of a form of non-invasive brain stimulation for the treatment of individuals with mild cognitive impairment (MCI) and dementia of the Alzheimer's Type (DAT).

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Detailed Description

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This research study is being done to learn important information about the effects of weak electrical stimulation on brain functioning in those with mild cognitive impairment (MCI) and dementia of the Alzheimer's type (DAT). The findings will help determine "how much" stimulation is needed to enhance memory and thinking abilities, how it affects brain functioning, and who is most likely to benefit. Ultimately, this information may guide treatment efforts for those at various stages of Alzheimer's disease. The study will use brain imaging to see whether these treatments change how participants learn and remember information. Functional magnetic resonance imaging (fMRI) and positron emission tomography (PET) scans will be used. The study will also use cognitive tests and questionnaires to examine whether participants' memory (and related abilities) change because of treatment. The study will enroll participants with a diagnosis of MCI or DAT. It is expected but not required that participants will be co-enrolled in the University of Michigan Memory and Aging Project (UM-MAP; HUM00000382).

Conditions

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Mild Cognitive Impairment Dementia of Alzheimer Type

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Eligible participants will be randomized 1:1:1:1 to receive either sham, 1mA, 2mA, or 3mA HD-tDCS for at least 5 sessions and up to 30 sessions using a blocked randomization design.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Sham Stimulation

Sham (placebo) dose of HD-tDCS treatment for 30 minutes, for between 5-30 sessions.

Group Type SHAM_COMPARATOR

Sham

Intervention Type DEVICE

Participants will receive sham (placebo) HD-tDCS for 30 minutes, for between 5-30 sessions.

1 mA Dosage Stimulation

1 milliAmp dose of HD-tDCS treatment for 30 minutes, for between 5-30 sessions.

Group Type EXPERIMENTAL

1 mA HD-tDCS

Intervention Type DEVICE

Participants will receive HD-tDCS at 1 mA for 30 minutes, for between 5-30 sessions.

2 mA Dosage Stimulation

2 milliAmp dose of HD-tDCS treatment for 30 minutes, for between 5-30 sessions.

Group Type EXPERIMENTAL

2 mA HD-tDCS

Intervention Type DEVICE

Participants will receive HD-tDCS at 2 mA for 30 minutes, for between 5-30 sessions.

3 mA Dosage Stimulation

3 milliAmp dose of HD-tDCS treatment for 30 minutes, for between 5-30 sessions.

Group Type EXPERIMENTAL

3 mA HD-tDCS

Intervention Type DEVICE

Participants will receive HD-tDCS at 3 mA for 30 minutes, for between 5-30 sessions.

Interventions

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1 mA HD-tDCS

Participants will receive HD-tDCS at 1 mA for 30 minutes, for between 5-30 sessions.

Intervention Type DEVICE

2 mA HD-tDCS

Participants will receive HD-tDCS at 2 mA for 30 minutes, for between 5-30 sessions.

Intervention Type DEVICE

3 mA HD-tDCS

Participants will receive HD-tDCS at 3 mA for 30 minutes, for between 5-30 sessions.

Intervention Type DEVICE

Sham

Participants will receive sham (placebo) HD-tDCS for 30 minutes, for between 5-30 sessions.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of Mild Cognitive Impairment (MCI) or dementia of the Alzheimer's type (DAT)
2. Must be MRI compatible, criteria that also apply for High Definition transcranial direct current stimulation (HD-tDCS; e.g., absence of metallic or electronic implants in the upper body or head)
3. Stable on relevant medications for at least 4 weeks prior to study enrollment