Brain Stimulation for Mild Cognitive Impairment

Overseen By Kathy Tasker

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Hebrew SeniorLife

Must not be taking: Neuroactive drugs

Disqualifiers: Major psychiatric, Parkinson's, Alzheimer's, others

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

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators have designed a brain stimulation study to understand its effect on an individual's standing, walking, and thinking abilities in older adults with and without mild cognitive impairments (MCI). The transcranial alternating current stimulation (tACS) technology has been safely and effectively used in hundreds of individuals. The purpose of this study is to test whether a single session of tACS as compared to sham intervention, improves standing, walking, and thinking in older adults with and without mild cognitive impairments (MCI). Approximately 60 people will take part in this study.

Research Team

Melike Kahya

Principal Investigator

Marcus Institute for Aging Research

Eligibility Criteria

This trial is for adults aged 65 and older, both with and without mild cognitive impairments (MCI), who can stand and walk on their own. Participants must have a MOCA score above 18, be able to understand the study's consent form, and agree to all requirements. Those with major psychiatric disorders, active cancer under treatment, recent severe illness or injury affecting mobility, neurodegenerative diseases other than MCI, or contraindications to brain stimulation are excluded.

Inclusion Criteria

I can stand and walk on my own.

I understand the study, can consent to it, and will follow all its requirements.

I am willing and able to follow all study requirements.

Exclusion Criteria

I am currently receiving chemotherapy or radiation for my cancer.

My MOCA score is 18 or higher.

I do not have major depression, schizophrenia, or psychosis.

Treatment Details

Interventions

• Real tACS
• Sham tACS

Trial Overview The study is examining the effects of transcranial alternating current stimulation (tACS) on standing balance, walking ability, and cognitive function in older adults. It compares real tACS against a sham (placebo-like) intervention in about 60 participants to see if it improves these functions in those with or without MCI.

Participant Groups

Group I: real tACS Active Control 1 Intervention

The investigators will administer the transcranial alternating current stimulation (tACS) intervention at 10 Hz to the participants. This intervention will utilize 6 electrodes; electrode placement and current parameters for each electrode have been optimized using a standard brain to generate an average electric field of 0.25 V/m. To ensure adherence to current safety recommendations for tACS, optimizations will be constrained to a maximum of total injected current 4.0 mA and a max. current per electrode of 2.0 mA. Stimulation will start and end with a 60 s ramp up/down to maximize comfort. This standard approach is both well-tolerated and safe in older adults. In a separate visit, we will use an active sham in which very low-level currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session.

Group II: sham tACS Placebo Group 1 Intervention

The investigators will administer the sham tACS intervention to the participants. They will use an active sham in which very low-level alternating currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session.

Who Is Running the Clinical Trial?

Hebrew SeniorLife

Lead Sponsor

Trials

52

Recruited

273,000+