A rTMS and Virtual Reality Based Cognitive Rehabilitation Program for MCI

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Central Arkansas Veterans Healthcare System
Study ID
NCT06024473
Status
Recruiting
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Conditions

  • ADL
  • Caregiver Burden
  • Mental Health Issue
  • Mild Cognitive Impairment
  • Quality of Life

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • rTMS — DEVICE
    Transcranial Magnetic Stimulation
  • rTMS+iVCT — DEVICE
    Transcranial Magnetic Stimulation and immersive virtual reality

Study Details

This clinical trial is being conducted to see if brain stimulation and brain training together improves cognitive functioning and mood in older adults diagnosed with Mild Cognitive Impairment (MCI). Brain stimulation will be done using repetitive Transcranial Magnetic Stimulation (rTMS). Brain training will be done using immersive virtual reality cognitive training (iVCT) program. The goals of this clinical trail are as follows: * Examine if rTMS+iVCT intervention can improve and sustain objective cognitive functioning in individuals with MCI more than control or rTMS only groups * Examine if rTMS+iVCT intervention improves participants mental health symptoms, functional abilities, and quality of life more than control or rTMS only groups * Examine the impact of rTMS+iVCT intervention on caregiver burden. Eligible participants will be assigned to a standard treatment (no intervention control) group, rTMS only group of rTMS+iVCT group. All participants will undergo baseline assessment to evaluate their cognitive, emotional, and functional abilities. Those in the rTMS only group will receive rTMS treatments for five days per week for two weeks (total of ten sessions). Those in the rTMS+iVCT group will receive rTMS treatment followed by iVCT training for five days a week for two weeks (total of ten sessions). All participants will then repeat testing 2 weeks and three months after baseline testing to assess for possible treatment related changes and lasting effects.

Key Dates

Start date
Mar 31, 2024
Status verified
Feb 2025
Primary completion
Mar 31, 2026
Completion
Sep 30, 2026

Study Design

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

Arms

  • No Intervention: Standard Treatment
    This arm will be followed without intervention
  • Active Comparator: rTMS
    This group will be randomized to receive rTMS treatment
  • Experimental: rTMS+iVCT
    This group will be randomized to receive rTMS and iVCT treatment

Primary Outcome Measure

Change in Hopkins Verbal Leaning Test Standard Score [ Time Frame: baseline, 2 weeks, 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Central Arkansas VA Healthcare systemLittle RockArkansas72114
Ian Moore, PhD
[email protected]
501-257-2152
[email protected]

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By research site
Central Arkansas VA Healthcare system· Little Rock, AR

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