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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Hebrew SeniorLife
Study ID
NCT05661084
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Transcranial alternating current stimulation (tACS) (active); Transcranial direct current stimulation (tDCS) (active) — DEVICE
    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.
  • Transcranial alternating current stimulation (tACS) (sham); Transcranial direct current stimulation (tDCS) (sham) — DEVICE
    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.
  • Transcranial alternating current stimulation (tACS) (active); Transcranial direct current stimulation (tDCS) (sham) — DEVICE
    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.
  • Transcranial alternating current stimulation (tACS) (sham); Transcranial direct current stimulation (tDCS) (active) — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jan 24, 2023
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Aug 31, 2027

Study Design

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

Arms

  • Experimental: tACS(AG) + tDCS(PFC) combo active
    Participants (Ps) will undergo 20min of daily home-based tACS active + tDCS active intervention over the left angular gyrus and prefrontal cortex for 4 weeks by their trained caregiver/administrators (As).
  • Active Comparator: tACS(AG) active + tDCS(PFC) sham
    Participants (Ps) will undergo 20min of daily home-based tACS active + tDCS sham intervention over the left angular gyrus and prefrontal cortex for 4 weeks by their trained caregiver/administrators (As).
  • Active Comparator: tACS(AG) sham + tDCS(PFC) active
    Participants (Ps) will undergo 20min of daily home-based tACS sham + tDCS active intervention over the left angular gyrus and prefrontal cortex for 4 weeks by their trained caregiver/administrators (As).
  • Sham Comparator: tACS(AG) sham + tDCS(PFC) sham
    Participants (Ps) will undergo 20min of daily home-based tACS sham + tDCS sham intervention over the left angular gyrus and prefrontal cortex for 4 weeks by their trained caregiver/administrators (As).

Primary Outcome Measure

Change in Rey Auditory Verbal Learning Test (RAVLT) Total Recall [ Time Frame: baseline, immediate post-intervention, 3 month follow up , 6 month follow up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hinda and Arthur Marcus Institute for Aging ResearchBostonMassachusetts02131
Alvaro Pascual-Leone, MD; PhD
[email protected]
617-971-5416
PhD
Davide Cappon, PhD (SUB_INVESTIGATOR)
Brad Manor, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Hinda and Arthur Marcus Institute for Aging Research· Boston, MA

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