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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after each hd-tdcs session, daily
Awards & highlights
STIM Trial 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.Check my eligibility
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.See study design
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.
STIM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My medications have not changed in the last 4 weeks.
Select...
I have been diagnosed with Mild Cognitive Impairment or Alzheimer's type dementia.
STIM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately following hd-tdcs sessions 5 and final session (<60 minutes)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately following hd-tdcs sessions 5 and final session (<60 minutes)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Lateral Temporal Cortex Connectivity
Secondary outcome measures
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 moreOther outcome measures
Change in Attention
Change in Cognitive Functioning
Change in Conceptualization Ability
+11 moreSTIM 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
1,675 Previous Clinical Trials
28,020,645 Total Patients Enrolled
University of MichiganLead Sponsor
1,798 Previous Clinical Trials
6,377,898 Total Patients Enrolled
Benjamin Hampstead, PhDPrincipal Investigator - Associate Professor
University of Michigan
2 Previous Clinical Trials
27 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My medications have not changed in the last 4 weeks.I have been diagnosed with Mild Cognitive Impairment or Alzheimer's type dementia.I have a specific neurological condition.You can't have any metal or electronic implants in your upper body or head that would interfere with MRI or High Definition transcranial direct current stimulation (HD-tDCS).I have severe difficulty with my senses (sight, hearing, touch).Specific mental health conditions
Research Study Groups:
This trial has the following groups:- Group 1: Sham Stimulation
- Group 2: 1 mA Dosage Stimulation
- Group 3: 2 mA Dosage Stimulation
- Group 4: 3 mA Dosage Stimulation
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment currently recruiting participants?
"Affirmative. As indicated on clinicaltrials.gov, this particular medical trial is currently recruiting participants. The study was first revealed to the public on April 1st 2019 and there have been subsequent updates as recently as March 2nd 2022. A total of 240 individuals are expected to take part in the experiment from a single location."
Answered by AI
What is the scope of enrollment in this research project?
"Affirmative, the online clinicaltrials.gov repository indicates that this research is actively recruiting participants. The original trial was uploaded on April 1st 2019 and updated as recently as March 2nd 2022; 240 subjects are needed at a single medical facility."
Answered by AI
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