Brain Stimulation for Mild Cognitive Impairment

(miniSTIM Trial)

Overseen By Alexandru Iordan, Ph.D

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Neurological conditions, Mental illness, Sensory impairments, Alcohol or drug abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 week

80 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What data supports the effectiveness of the treatment Transcranial Direct Current Stimulation (tDCS) for mild cognitive impairment?

Research suggests that transcranial direct current stimulation (tDCS) can help improve cognitive functions in people with mild cognitive impairment (MCI) and Alzheimer's disease. Studies have shown that tDCS, especially when combined with cognitive training, may enhance memory and other cognitive abilities in these conditions. ^{1 2 3 4 5}

Is transcranial direct current stimulation (tDCS) safe for humans?

Transcranial direct current stimulation (tDCS) is generally considered safe for humans, with no serious adverse effects reported in over 33,200 sessions across various populations, including potentially vulnerable groups like children and the elderly. Some mild side effects, such as skin irritation, may occur, but these are usually temporary. ^{6 7 8 9 10}

How is the treatment Transcranial Direct Current Stimulation (tDCS) unique for mild cognitive impairment?

Transcranial Direct Current Stimulation (tDCS) is unique because it is a non-invasive brain stimulation technique that can enhance cognitive function by applying a small electrical current to specific brain areas, unlike traditional drug treatments. It is particularly promising for mild cognitive impairment as it may help improve or delay cognitive decline without the side effects associated with medications. ^{1 2 3 4 11}

What is the purpose of this trial?

This study will evaluate the effects of a form of non-invasive brain stimulation on brain functioning and memory in cognitively intact older adults (healthy controls, HC) and in those with mild cognitive impairment (MCI).

Research Team

Alexandru Iordan, Ph.D

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for older adults who are either cognitively healthy or have mild cognitive impairment. Participants should be able to perform daily activities with minimal assistance and must not have any neurological disorders other than MCI.

Inclusion Criteria

I have normal thinking abilities or have been diagnosed with Mild Cognitive Impairment.

Right-handedness

Magnetic resonance 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)

Exclusion Criteria

I have a medical condition that affects my thinking or memory.

Significant mental illness

History of alcohol or drug abuse/dependence

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive HD-tDCS treatment or sham for 20 minutes in 1 session

1 week

1 visit (in-person)

Follow-up

Participants are monitored for changes in brain activation and memory performance

1 week

Treatment Details

Interventions

• Transcranial Direct Current Stimulation (tDCS)

Trial Overview The study is testing the effects of a non-invasive brain stimulation technique called tDCS on brain function and memory. There will be two groups: one receiving active tDCS and another receiving sham (placebo) treatment.

Participant Groups

Group I: MCI active tDCS Experimental Treatment 1 Intervention

3 milliAmp dose of HD-tDCS treatment for 20 minutes, for 1 session.

Group II: HC active tDCS Experimental Treatment 1 Intervention

3 milliAmp dose of HD-tDCS treatment for 20 minutes, for 1 session.

Group III: HC sham tDCS Placebo Group 1 Intervention

Sham (placebo) dose of HD-tDCS treatment for 20 minutes, for 1 session.

Group IV: MCI sham tDCS Placebo Group 1 Intervention

Sham (placebo) dose of HD-tDCS treatment for 20 minutes, for 1 session.

Transcranial Direct Current Stimulation (tDCS) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Transcranial Direct Current Stimulation for:

• Depression
• Stroke rehabilitation
• Chronic pain management
• Research use for various neurological and psychiatric conditions including autism spectrum disorder

Approved in European Union as Transcranial Direct Current Stimulation for:

• Depression
• Stroke rehabilitation
• Chronic pain management
• Research use for various neurological and psychiatric conditions including autism spectrum disorder

Approved in Canada as Transcranial Direct Current Stimulation for:

• Depression
• Stroke rehabilitation
• Chronic pain management
• Research use for various neurological and psychiatric conditions including autism spectrum disorder

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Wayne State University

Collaborator

Trials

318

Recruited

111,000+

Alzheimer's Association

Collaborator

Trials

103

Recruited

44,300+

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential of Transcranial Direct Current Stimulation in Alzheimer's Disease: Optimizing Trials Toward Clinical Use. Pilloni, G., Charvet, LE., Bikson, M., et al.[2022]

Anodal transcranial direct current stimulation (tDCS) applied to the left dorsolateral prefrontal cortex significantly improved cognitive tasks related to processing speed, selective attention, and planning in five older adults with mild cognitive impairment (MCI).

The study suggests that combining tDCS with cognitive stimulation programs may enhance cognitive performance in individuals with MCI, but further research is needed to explore long-term effects and practical applications in daily life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Transcranial Direct Current Stimulation on the Cognitive Functions in Older Adults with Mild Cognitive Impairment: A Pilot Study. Cruz Gonzalez, P., Fong, KNK., Brown, T.[2022]

In a study involving 34 patients with mild cognitive impairment (MCI), those receiving 20 days of anodal transcranial direct current stimulation (tDCS) showed significant improvements in cognitive functions, including episodic verbal memory and overall cognitive function, compared to a sham group.

The results suggest that anodal tDCS may enhance cognitive symptoms in MCI patients, indicating its potential as a therapeutic tool, although further research is needed to clarify the underlying mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects on cognition of 20-day anodal transcranial direct current stimulation over the left dorsolateral prefrontal cortex in patients affected by mild cognitive impairment: a case-control study. Fileccia, E., Di Stasi, V., Poda, R., et al.[2020]

In a study involving 22 participants with mild cognitive impairment (MCI), anodal transcranial direct current stimulation (a-tDCS) combined with cognitive training did not enhance cognitive performance compared to sham stimulation, despite increasing blood flow in the right middle frontal cortex.

Cognitive training alone (SMART) showed significant improvements in executive function and memory in the sham group, but these gains did not last for three months, highlighting the potential of cognitive training in improving cognitive performance in MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Training and Transcranial Direct Current Stimulation in Mild Cognitive Impairment: A Randomized Pilot Trial. Das, N., Spence, JS., Aslan, S., et al.[2022]

In a study involving 17 patients with mild cognitive impairment (MCI) or mild Alzheimer's disease (AD), bitemporal transcranial direct current stimulation (tDCS) significantly improved performance on a memory task (2-back accuracy) compared to bifrontal and sham stimulation.

The stimulation was found to be safe, with only mild and temporary adverse effects reported, indicating that bitemporal tDCS could be a beneficial intervention for enhancing memory in patients with MCI and mild AD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study Comparing Effects of Bifrontal Versus Bitemporal Transcranial Direct Current Stimulation in Mild Cognitive Impairment and Mild Alzheimer Disease. Liu, CS., Herrmann, N., Gallagher, D., et al.[2022]

Transcranial Direct Current Stimulation (tDCS) has been shown to be safe, with no reports of Serious Adverse Effects or irreversible injuries across over 33,200 sessions involving more than 1,000 subjects, including vulnerable populations.

Safety assessments indicate that the current densities used in conventional tDCS (≤4 milliamperes) are significantly lower than those that could potentially cause brain injury, suggesting that tDCS protocols are well within safe limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Bikson, M., Grossman, P., Thomas, C., et al.[2022]

A systematic review of 64 studies involving 2262 participants found that transcranial direct current stimulation (tDCS) has a low dropout rate (6% for active and 7.2% for sham), indicating good acceptability among participants.

Despite the low dropout rates, many studies inadequately reported adverse events (AEs), highlighting a need for improved guidelines to standardize AE reporting in tDCS research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. Aparício, LVM., Guarienti, F., Razza, LB., et al.[2018]

Transcranial Direct Current Stimulation (tDCS) is generally considered safe, but there are concerns that it could lead to significant negative effects in healthy individuals.

The scientific community needs to be alerted about the potential risks of tDCS, emphasizing the importance of protecting healthy volunteers from possible harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcranial direct current stimulation in healthy participants. Boccard-Binet, S., Sen, A.[2021]

Microdermabrasion significantly reduced skin resistance by about 32%, allowing for higher doses of transcranial direct current stimulation (tDCS) without increasing skin sensations or device limitations.

The study found that while microdermabrasion increased perceived sensations slightly when not combined with sonication, overall, it enabled safer and more effective delivery of tDCS by lowering the voltage needed to achieve the same current.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. Chhatbar, PY., Liu, S., Ramakrishnan, V., et al.[2023]

High Definition transcranial direct current stimulation (HD-tDCS) is safe and well-tolerated in older adults, with no serious adverse events reported during a study involving 101 participants at stimulation intensities of 2 mA and 3 mA.

The study demonstrated effective blinding, as participants could not accurately distinguish between active and sham stimulation, indicating that HD-tDCS can be reliably used in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps. Reckow, J., Rahman-Filipiak, A., Garcia, S., et al.[2020]

In a study involving 11 patients with Mild Cognitive Impairment (MCI), transcranial direct current stimulation (tDCS) was found to be safe and well-tolerated, with no significant adverse effects reported during the treatment.

tDCS significantly improved memory recall in patients, with benefits observed immediately after treatment and persisting for at least one month, suggesting its potential as a therapeutic strategy for cognitive deficits in MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical utility and tolerability of transcranial direct current stimulation in mild cognitive impairment. Murugaraja, V., Shivakumar, V., Sivakumar, PT., et al.[2022]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Potential of Transcranial Direct Current Stimulation in Alzheimer's Disease: Optimizing Trials Toward Clinical Use. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

The Effects of Transcranial Direct Current Stimulation on the Cognitive Functions in Older Adults with Mild Cognitive Impairment: A Pilot Study. [2022]

3. Italy pubmed.ncbi.nlm.nih.gov

Effects on cognition of 20-day anodal transcranial direct current stimulation over the left dorsolateral prefrontal cortex in patients affected by mild cognitive impairment: a case-control study. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Cognitive Training and Transcranial Direct Current Stimulation in Mild Cognitive Impairment: A Randomized Pilot Trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

A Pilot Study Comparing Effects of Bifrontal Versus Bitemporal Transcranial Direct Current Stimulation in Mild Cognitive Impairment and Mild Alzheimer Disease. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Safety of transcranial direct current stimulation in healthy participants. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Tolerability and blinding of 4x1 high-definition transcranial direct current stimulation (HD-tDCS) at two and three milliamps. [2020]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical utility and tolerability of transcranial direct current stimulation in mild cognitive impairment. [2022]