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: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether transcranial alternating current stimulation (tACS) can improve standing, walking, and thinking in older adults. Participants will undergo a single session, receiving either real tACS or a sham version, to determine any noticeable benefits. The trial seeks older adults who can stand and walk independently and have mild cognitive impairment or none. Participants will help researchers determine if tACS can ease daily activities for individuals with these conditions. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could enhance the quality of life for older adults.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using neuroactive drugs (medications that affect the brain). It's best to discuss your specific medications with the study team.

What prior data suggests that this brain stimulation technique is safe for older adults?

Research has shown that transcranial alternating current stimulation (tACS) is generally safe and well-tolerated. Studies have safely used tACS in hundreds of participants, including those with mild Alzheimer’s disease, often finding few serious side effects. Common, mild side effects include slight tingling or itching at the stimulation site, which usually doesn't last long. By using low electrical currents and carefully placing the electrodes, tACS meets safety standards. This makes it a promising option for those interested in clinical trials involving brain stimulation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for mild cognitive impairment involve medications that target neurotransmitter imbalances, such as cholinesterase inhibitors or memantine. However, transcranial alternating current stimulation (tACS) works differently by using electrical currents to stimulate the brain directly. This non-invasive method is designed to enhance brain activity and connectivity, offering a novel approach that could potentially improve cognitive function without the side effects associated with drugs. Researchers are excited about tACS because it represents a shift from chemical to electrical intervention, which could offer safer and potentially quicker cognitive benefits for older adults.

What evidence suggests that this trial's treatments could be effective for mild cognitive impairment?

Research has shown that transcranial alternating current stimulation (tACS) can assist individuals with mild cognitive impairment (MCI). In one study, seven trials involving 246 patients demonstrated improvements in symptoms of Alzheimer's disease and MCI. Another study found that a single session of tACS enhanced memory. This trial will compare real tACS, customized to fit a person's brain structure, with sham tACS. Overall, tACS is considered safe and has shown positive effects on thinking skills, making it a promising option for older adults with MCI. ^{2 3 6 7 8}

Who Is on the Research Team?

Melike Kahya

Principal Investigator

Marcus Institute for Aging Research

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo dual-task standing and cognitive assessments immediately before and after single sessions of 10 Hz tACS and active-sham

1 day

2 visits (in-person)

Follow-up

Participants are monitored for changes in EEG alpha-band power and postural sway speed

4 weeks

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11712744/

Efficacy of Transcranial Alternating Current Stimulation ... We included a total of seven randomized controlled trials comprising 246 patients with Alzheimer's disease or mild cognitive impairment. Our primary outcomes ...

2. translationalneurodegeneration.biomedcentral.com translationalneurodegeneration.biomedcentral.com/articles/10.1186/s40035-024-00423-y

Transcranial alternating current stimulation (tACS) at gamma ... We outline the current knowledge concerning the clinical efficacy, safety, ease-of-use and cost-effectiveness of tACS on early and advanced AD.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1388245725007825

MRI-individualized, multi-electrode tACS enhances the ... Personalized MRI-based tACS improves targeted brain stimulation in mild cognitive impairment patients. Optimized brain stimulation enhances electric field ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06202872

Memory Enhancement Using Transcranial Alternating ... In these patients, a single session of 40 Hz tACS at the precuneus showed to improve episodic memory and to increase gamma power, as measured with ...

5. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2022.962684/full

Transcranial alternating current stimulation combined with ... There was a beneficial effect on cognition after intervention in two patients with Alzheimer's disease-related dementia (ADRD) for a 14-week ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7158579/

TRanscranial AlterNating current Stimulation FOR patients ... The aim of this double‐blind, randomized controlled trial is to examine the efficacy and safety of 40 Hz tACS in patients with mild AD dementia. The tACS ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X21000589

Exposure to gamma tACS in Alzheimer's disease Exposure to γ-tACS over Pz showed a significant improvement of memory performances, along with restoration of intracortical connectivity measures of ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10920470/

Cognitive and Neuropathophysiological Outcomes of Gamma ... Overall, despite the variability in stimulation parameters, all studies found that gamma-tACS was well-tolerated and induced significant improvements in memory ...