240 Participants Needed

Brain Stimulation for Alzheimer's Disease

(STIM Trial)

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Overseen ByEileen A Robinson, RN-BC
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Michigan
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial requires that you have been stable on your current medications for at least 4 weeks before joining, so you should not stop taking them.

What data supports the effectiveness of the treatment HD-tDCS for Alzheimer's Disease?

Research suggests that transcranial direct current stimulation (tDCS), a non-invasive brain stimulation method, shows promise in improving cognitive function and memory in Alzheimer's patients. Studies indicate that tDCS is safe and may help slow down cognitive decline in Alzheimer's disease.12345

Is brain stimulation for Alzheimer's disease safe for humans?

Transcranial Direct Current Stimulation (tDCS), including its high-definition version (HD-tDCS), is generally considered safe and well-tolerated in humans, with no serious adverse effects reported in over 33,200 sessions. However, some studies suggest it could potentially cause harm, so caution is advised.36789

How is HD-tDCS treatment different from other Alzheimer's treatments?

HD-tDCS (High Definition Transcranial Direct Current Stimulation) is unique because it is a non-invasive brain stimulation method that specifically targets brain areas with more precision than traditional methods, potentially improving memory and cognitive function in Alzheimer's patients without the side effects associated with drugs.1241011

Research Team

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Benjamin Hampstead, PhD

Principal Investigator

Associate Professor

Eligibility Criteria

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.

Inclusion Criteria

My medications have not changed in the last 4 weeks.
I have been diagnosed with Mild Cognitive Impairment or Alzheimer's type dementia.
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).

Exclusion Criteria

I have a specific neurological condition.
I have severe difficulty with my senses (sight, hearing, touch).
Specific mental health conditions

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive HD-tDCS treatment with varying doses (sham, 1 mA, 2 mA, 3 mA) for 30 minutes per session, for between 5-30 sessions

5-30 sessions
Daily sessions

Follow-up

Participants are monitored for changes in cognitive functioning and brain connectivity post-treatment

4 weeks

Treatment Details

Interventions

  • HD-tDCS
  • Sham
Trial OverviewThe 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.
Participant Groups
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.

HD-tDCS is already approved in United States, European Union, Canada for the following indications:

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Approved in United States as HD-tDCS for:
  • Depression
  • Anxiety disorders
  • Cognitive enhancement
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Approved in European Union as HD-tDCS for:
  • Major depressive disorder
  • Chronic pain management
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Approved in Canada as HD-tDCS for:
  • Depression
  • Anxiety disorders

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials
1,891
Recruited
6,458,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Findings from Research

Transcranial direct current stimulation (tDCS) is a safe and noninvasive method that shows promise in treating cognitive decline associated with Alzheimer's disease and mild cognitive impairment.
The review highlights the need for further large-scale clinical trials to better understand the mechanisms of tDCS and improve its application in clinical settings.
Potential of Transcranial Direct Current Stimulation in Alzheimer's Disease: Optimizing Trials Toward Clinical Use.Pilloni, G., Charvet, LE., Bikson, M., et al.[2022]
The novel high-definition transcranial direct current stimulation (HD-tDCS) setup was found to be safe and well-tolerated, with fewer adverse effects compared to conventional tDCS, based on a study involving 60 healthy participants.
HD-tDCS significantly improved cognitive performance on a visual task, indicating its potential for more effective neural modulation, while also being compatible with simultaneous fMRI without causing significant heating or image quality issues.
Safety, Tolerability, Blinding Efficacy and Behavioural Effects of a Novel MRI-Compatible, High-Definition tDCS Set-Up.Gbadeyan, O., Steinhauser, M., McMahon, K., et al.[2022]
High-Definition transcranial Direct Current Stimulation (HD-tDCS) at amplitudes up to 4 mA was well tolerated by 292 older adults, with no safety-related adverse events reported and mostly mild sensations experienced during sessions.
The study demonstrated effective blinding for both participants and researchers, indicating that the sham stimulation was convincing, which supports the use of higher amplitudes for potentially greater therapeutic effects in older adults.
Tolerability and blinding of high-definition transcranial direct current stimulation among older adults at intensities of up to 4 mA per electrode.El Jamal, C., Harrie, A., Rahman-Filipiak, A., et al.[2023]

References

Potential of Transcranial Direct Current Stimulation in Alzheimer's Disease: Optimizing Trials Toward Clinical Use. [2022]
Safety, Tolerability, Blinding Efficacy and Behavioural Effects of a Novel MRI-Compatible, High-Definition tDCS Set-Up. [2022]
Tolerability and blinding of high-definition transcranial direct current stimulation among older adults at intensities of up to 4 mA per electrode. [2023]
Transcranial direct current stimulation improves recognition memory in Alzheimer disease. [2022]
Transcranial Direct Current Stimulation Improves Cognitive Function in Mild to Moderate Alzheimer Disease: A Meta-Analysis. [2020]
Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps. [2020]
Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]
A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. [2018]
Safety of transcranial direct current stimulation in healthy participants. [2021]
Action mechanisms of transcranial direct current stimulation in Alzheimer's disease and memory loss. [2021]
Behavioural and electrophysiological modulations induced by transcranial direct current stimulation in healthy elderly and Alzheimer's disease patients: A pilot study. [2020]