NCT05661084

Non-invasive Brain Stimulation for Cognitive and Motor Dysfunction in Dementia

Multifocal Transcranial Current Stimulation for Cognitive and Motor Dysfunction in Dementia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Hebrew SeniorLife · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

This project aims to examine the efficacy of remote, caregiver-led tES/brain stimulation intervention targeted to improve memory, mobility, and executive functioning among older adults with mild cognitive impairment or mild dementia.

Detailed description

This is a randomized controlled trial to test the efficacy of a home-based brain stimulation intervention of tACS (for angular gyrus) and tDCS (for the prefrontal cortex) to improve memory, mobility, and executive function. It will include 144 older adults with mild dementia or mild cognitive impairment and their caregiver/administrator who will be trained to lead the remote, home-based brain stimulation. Participants will be randomized into one of four conditions, a) active combination of tACS + tDCS, b) combination of active tACS + sham tDCS, c) combination of sham tACS + active tDCS, and d) combination of sham tACS + sham tDCS. Participants will engage in a set of pre-intervention assessments, the brain stimulation intervention--consisting of 20, once-daily 30-min stimulation sessions administered over a 4-week period, and a set of post-intervention assessments (immediately following brain stimulation, 3 months post-brain stimulation, and 6 months post-brain stimulation). This project is expected to demonstrate that tACS and tDCS can be combined to optimize the functional impact of a home-based tES intervention for older adults with mild dementia.

Conditions

• Dementia
• Memory Loss
• Alzheimer Disease
• Executive Dysfunction
• Mobility Limitation

Interventions

Type	Name	Description
DEVICE	Transcranial alternating current stimulation (tACS) (active); Transcranial direct current stimulation (tDCS) (active)	Transcranial electrical stimulation (tES), via alternating and direct current, will be administered to the participant in their home by their caregiver administrator to the left angular gyrus and prefrontal cortex.
DEVICE	Transcranial alternating current stimulation (tACS) (sham); Transcranial direct current stimulation (tDCS) (sham)	A sham transcranial electrical stimulation (tES) will be administered to the participant in their home by their caregiver administrator to the left angular gyrus and prefrontal cortex. It will physically mimic active stimulation.
DEVICE	Transcranial alternating current stimulation (tACS) (active); Transcranial direct current stimulation (tDCS) (sham)	Transcranial electrical stimulation (tES), via alternating and direct current, will be administered to the participant in their home by their caregiver administrator. Active tACS to the left angular gyrus and sham tDCS to the prefrontal cortex.
DEVICE	Transcranial alternating current stimulation (tACS) (sham); Transcranial direct current stimulation (tDCS) (active)	Transcranial electrical stimulation (tES), via alternating and direct current, will be administered to the participant in their home by their caregiver administrator. Sham tACS to the left angular gyrus and active tDCS to the prefrontal cortex.

Timeline

• Start date: 2023-01-24
• Primary completion: 2026-12-31
• Completion: 2027-08-31
• First posted: 2022-12-22
• Last updated: 2026-01-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study