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Non-invasive Brain Stimulation

Brain Stimulation for Alzheimer's Disease (STIM Trial)

N/A
Recruiting
Led By Benjamin Hampstead, PhD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stable on relevant medications for at least 4 weeks prior to study enrollment
Diagnosis of Mild Cognitive Impairment (MCI) or dementia of the Alzheimer's type (DAT)
Must not have
Certain neurological diseases
Severe sensory impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately following hd-tdcs sessions 5 and final session (<60 minutes)

Summary

This trial will test if different doses of non-invasive brain stimulation can help people with mild cognitive impairment or early Alzheimer's disease.

Who is the study for?
This trial is for individuals with mild cognitive impairment or dementia of the Alzheimer's type who can have an MRI and don't have metal/electronic implants in their upper body/head. They must be stable on current medications for at least 4 weeks.
What is being tested?
The study tests non-invasive brain stimulation (HD-tDCS) at different doses (1 mA, 2 mA, and 3 mA) versus a sham treatment to see its effects on memory in people with cognitive issues related to Alzheimer's.
What are the potential side effects?
Possible side effects of HD-tDCS may include discomfort at the electrode site, itching, tingling, headache, fatigue, and in rare cases seizures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My medications have not changed in the last 4 weeks.
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I have been diagnosed with Mild Cognitive Impairment or Alzheimer's type dementia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a specific neurological condition.
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I have severe difficulty with my senses (sight, hearing, touch).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and post-intervention (after tdcs sessions 5 & 30)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and post-intervention (after tdcs sessions 5 & 30) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Lateral Temporal Cortex Connectivity
Secondary study objectives
Change in Overall Fluid Cognitive Abilities
Cumulative Memory Accuracy Effects of HD-tDCS across daily sessions
Cumulative Memory Reaction Time Effects of HD-tDCS across daily sessions
+6 more
Other study objectives
Change in Attention
Change in Cognitive Functioning
Change in Conceptualization Ability
+11 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: 3 mA Dosage StimulationExperimental Treatment1 Intervention
3 milliAmp dose of HD-tDCS treatment for 30 minutes, for between 5-30 sessions.
Group II: 2 mA Dosage StimulationExperimental Treatment1 Intervention
2 milliAmp dose of HD-tDCS treatment for 30 minutes, for between 5-30 sessions.
Group III: 1 mA Dosage StimulationExperimental Treatment1 Intervention
1 milliAmp dose of HD-tDCS treatment for 30 minutes, for between 5-30 sessions.
Group IV: Sham StimulationPlacebo Group1 Intervention
Sham (placebo) dose of HD-tDCS treatment for 30 minutes, for between 5-30 sessions.

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,789 Previous Clinical Trials
28,188,092 Total Patients Enrolled
University of MichiganLead Sponsor
1,855 Previous Clinical Trials
6,434,821 Total Patients Enrolled
Benjamin Hampstead, PhDPrincipal Investigator - Associate Professor
University of Michigan
2 Previous Clinical Trials
36 Total Patients Enrolled

Media Library

HD-tDCS (Non-invasive Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT03875326 — N/A
Mild Cognitive Impairment Research Study Groups: Sham Stimulation, 1 mA Dosage Stimulation, 2 mA Dosage Stimulation, 3 mA Dosage Stimulation
Mild Cognitive Impairment Clinical Trial 2023: HD-tDCS Highlights & Side Effects. Trial Name: NCT03875326 — N/A
HD-tDCS (Non-invasive Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03875326 — N/A
~20 spots leftby May 2025
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