Brain Stimulation and Cognitive Training for MCI

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT07526740
Status
Recruiting
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Conditions

  • Cognition Disorders
  • Cognitive Dysfunction
  • Mild Cognitive Impairment (MCI)
  • Mild Neurocognitive Disorder
  • Neurocognitive Disorders

Eligibility Criteria

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

Interventions

  • Accelerated iTBS — DEVICE
    A MagVenture MagPro Transcranial Magnetic Stimulation (TMS) System with Brainsight neuronavigation will be used. All participants will receive active treatment: 12 sessions (3 min each) of iTBS on each of 3 treatment days within an 8-day span. A single session = 600 pulses of 50 Hz iTBS triplets delivered every 200ms in 2s trains repeated every 10s (8s inter-train interval) for 190s. Stimulation intensity is 120% resting motor threshold (rMT) delivered at the left dorsolateral prefrontal cortex. Total pulses = 21,600. Inter-session intervals will be approx. 15 min.
  • Computerized Cognitive Training — DEVICE
    CCT will be delivered through the online BrainHQ platform. Participants will engage in adaptive visual speed of processing training during the 15-min breaks between iTBS sessions (11 sessions on each treatment day, total CCT time = 495 min).
  • Sham Computerized Cognitive Training — DEVICE
    Sham CCT will be delivered through the online BrainHQ platform. Participants will engage in non-adaptive control games during the 15-min breaks between iTBS sessions (11 sessions on each treatment day, total sham CCT time = 495 min).

Study Details

This is a randomized clinical trial of a treatment that combines non-invasive brain stimulation with computerized cognitive training (CCT) for people with mild cognitive impairment (MCI). The form of brain stimulation used in this study is accelerated intermittent theta burst stimulation (iTBS). All participants receive the same amount of iTBS and are randomly assigned to engage in one of two types of CCT. The goals of the study are to see if this combined treatment is feasible and acceptable to people with MCI and whether combined iTBS and CCT improves memory, thinking skills, mood, and daily function.

Key Dates

Start date
Mar 16, 2026
Status verified
May 2026
Primary completion
May 31, 2030
Completion
May 31, 2030

Study Design

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

Arms

  • Experimental: iTBS+CCT
    Participants will receive 12 sessions of accelerated iTBS and 11 sessions of active CCT on each of 3 treatment days.
  • Sham Comparator: iTBS+shamCCT
    Participants will receive 12 sessions of accelerated iTBS and 11 sessions of sham CCT on each of 3 treatment days.

Primary Outcome Measure

Retention [ Time Frame: From enrollment to the end of study at week 6 (1-month post-treatment assessment). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South CarolinaCharlestonSouth Carolina29425
Kaitlin Cox
843-608-1674

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By research site
Medical University of South Carolina· Charleston, SC

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