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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a form of brain stimulation called transcranial direct current stimulation (tDCS) to determine its effects on brain function and memory. The focus is on individuals with mild cognitive impairment (MCI), characterized by noticeable memory or thinking difficulties that do not interfere with daily life. The trial compares real tDCS treatment to a placebo (fake treatment) in both healthy older adults and those with MCI. Suitable candidates are right-handed individuals with normal cognitive function or a diagnosis of MCI, who do not have metal implants in their upper body or head. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on brain health and memory improvement.

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 prior data suggests that Transcranial Direct Current Stimulation (tDCS) is safe for use in this study?

Research shows that transcranial direct current stimulation (tDCS) is generally safe. Studies have found it can be used safely for up to 20 days and can significantly enhance thinking skills without major side effects. Although researchers continue to study tDCS, it is considered well-tolerated. Some people might experience mild tingling or itching on their scalp during treatment, but these sensations are usually temporary and harmless. Overall, available research reassures the safety of tDCS. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Transcranial Direct Current Stimulation (tDCS) for mild cognitive impairment because it offers a non-invasive approach that directly modulates brain activity. Unlike traditional treatments like medications, which often aim to manage symptoms by altering chemical balances in the brain, tDCS uses electrical currents to target specific brain areas, potentially enhancing cognitive function more precisely. This method is appealing because it may provide quicker results with fewer side effects, making it a promising alternative or complement to existing treatments.

What evidence suggests that Transcranial Direct Current Stimulation (tDCS) might be an effective treatment for mild cognitive impairment?

Research has shown mixed results for using transcranial direct current stimulation (tDCS) in people with mild cognitive impairment (MCI). Some studies suggest that tDCS can improve brain function and memory in individuals with Alzheimer's disease, but the benefits for those with MCI remain unclear. For instance, one study found no significant improvement in thinking skills with active tDCS compared to a sham treatment. However, another analysis indicated that tDCS might enhance brain function more than not using it at all. While some research suggests that tDCS can aid memory in MCI, the overall evidence remains weak. This trial will compare active tDCS with sham tDCS to further investigate its effects on MCI. ^{3 4 6 7 8}

Who Is on the Research Team?

Alexandru Iordan, Ph.D

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11090525/

Transcranial direct current stimulation-efficacy in mild ...

The current meta-analysis identified insignificant improvement in cognitive performance with active tDCS treatment as compared to sham tDCS among people with ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39089145/

Systematic review and meta-analysis of transcranial direct ...

Conclusion: The tDCS can ameliorate the global cognition of patients with MCI and AD, and it has a better rehabilitation effect than non-tDCS or sham-tDCS.

3.

journals.lww.com

journals.lww.com/jops/fulltext/2025/01000/efficacy_of_transcranial_direct_current.11.aspx

Efficacy of Transcranial Direct Current Stimulation on...

The study findings suggest that tDCS is effective in improving global cognition in participants with Alzheimer's dementia but not MCI.

4.

alzres.biomedcentral.com

alzres.biomedcentral.com/articles/10.1186/s13195-025-01677-y

A systematic review and meta-analysis of the impact of ...

People with AD showed greater improvements compared to those with MCI or dementia (SMD = 0.91, p = 0.02). However, tDCS did not significantly ...

5.

frontiersin.org

frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2024.1436448/full

The effects of repetitive transcranial magnetic and ...

The results suggest that both rTMS and tDCS improved memory functions in patients with MCI compared with sham stimulation, but the efficacy of ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11040101/

Safety and feasibility of optimized transcranial direct current ...

Previous research has shown that tDCS can be safely used for 20 days and has significant effects on cognitive function (11, 12). Although there ...

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0197457224001927

Systematic review and meta-analysis of transcranial ...

The tDCS can ameliorate the global cognition of patients with MCI and AD, and it has a better rehabilitation effect than non-tDCS or sham-tDCS.

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11306417/

Efficacy and Safety of Transcranial Magnetic Stimulation on ...

The reviewed studies provide favorable evidence of improved cognition with TMS across all groups with cognitive impairment. TMS was safe and ...