Brain Stimulation and Cognitive Training for MCI

Summary

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.

Conditions

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

Interventions

DEVICE

Accelerated iTBS

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.

DEVICE

Computerized Cognitive Training

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).

DEVICE

Sham Computerized Cognitive Training

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).

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• National Institute on Aging (NIA)

  collaborator NIH

• Medical University of South Carolina

  lead OTHER

Principal Investigators

• Stephanie Aghamoosa · Medical University of South Carolina

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-16

Primary Completion

2030-05-31

Completion

2030-05-31

FDA Device

Yes

Countries

• United States

Study Locations