Multi-session Transcranial Alternating Current Stimulation to Improve Dual-task Standing and Brain Activity in Older Adults With Mild Cognitive Impairment

Part of paid clinical trials in High Point, North Carolina.

Sponsor
High Point University
Study ID
NCT07097051
Phase
PHASE2
Status
Recruiting
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Conditions

  • Mild Cognitive Impairment (MCI)

Eligibility Criteria

Sex
ALL
Age
65 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • real tACS — OTHER
    Those who randomized into real tACS arm will receive ten-session of individually tailored tACS targeting peak alpha power for 20-minutes
  • sham tACS — OTHER
    Those who randomized into sham tACS arm will receive ten-session of active sham tACS intervention for 20-minutes

Study Details

Older adults with Mild Cognitive Impairment (MCI) often show less brain activity in a specific range (8-13 Hz, known as alpha power) compared to healthy older adults. Those with lower alpha activity, especially in the front part of the brain, usually have problems with executive functions like planning and multitasking. Our research has shown that older adults with lower alpha power in these areas also struggle more with balance when they have to do two things at once (like standing and performing a cognitive task simultaneously). The investigators believe that increasing alpha power in older adults with MCI could improve their balance and executive function, helping them stay independent longer. In early studies, the investigators found that using transcranial alternating current stimulation (tACS) at 10 Hz on the front part of the brain can boost alpha power and balance immediately after a single session in older adults with MCI. The effect was stronger in those whose natural brain activity was close to the 10 Hz stimulation. Based on these findings, the investigators plan to conduct a pilot study with older adults aged 65-85 years with MCI. Participants will be randomly assigned to receive either real tACS or a sham (placebo) treatment. Our main hypothesis is that real tACS will improve balance when multitasking, and these improvements will last for 1 to 3 months after the treatment. The investigators also believe that tACS will enhance other aspects of executive function and mobility and that these improvements will be linked to increased alpha activity in the brain. Through this study, we aim to gather strong evidence that tailored tACS is a promising treatment to improve cognitive and motor functions and overall brain activity in older adults with MCI.

Key Dates

Start date
May 13, 2025
Status verified
Jul 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: real tACS
    The investigators will administer the transcranial alternating current stimulation (tACS) intervention individually tailored to peak alpha power to the participants. This intervention will utilize 8 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 and the entire session will take 22-minute. This standard approach is both well-tolerated and safe in older adults.
  • Placebo Comparator: sham tACS
    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 session. Stimulation will start and end with a 60 s ramp up/down to maximize comfort and the entire session will last in 22-minutes.

Primary Outcome Measure

EEG alpha-band power [ Time Frame: Baseline, immediate post-intervention assessments, Follow-up visit #1 (4 weeks later of post-intervention assessment, Follow-up visit #2 (12 weeks later post-intervention assessment). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
High Point UniversityHigh PointNorth Carolina27262
Melike Kahya
[email protected]
3368419632

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