Stimulation to Improve Memory (STIM)

University of Michigan

Status: Completed

Conditions: Dementia of Alzheimer Type; Mild Cognitive Impairment

Treatments: Device: 1 mA HD-tDCS; Device: Sham; Device: 3 mA HD-tDCS; Device: 2 mA HD-tDCS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03875326

HUM00146180

1R01AG058724 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full description

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).

Enrollment: 269 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

1. Certain neurological diseases
2. Certain psychiatric conditions
3. Severe sensory impairment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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269 participants in 4 patient groups

Sham Stimulation

Sham Comparator group

Description:

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

Treatment:

Device: Sham

1 mA Dosage Stimulation

Experimental group

Description:

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

Treatment:

Device: 1 mA HD-tDCS

2 mA Dosage Stimulation

Experimental group

Description:

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

Treatment:

Device: 2 mA HD-tDCS

3 mA Dosage Stimulation

Experimental group

Description:

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

Treatment:

Device: 3 mA HD-tDCS