Transcranial Magnetic Stimulation for MCI

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

June 18, 2024

Primary Completion Date

April 30, 2028

Study Completion Date

April 30, 2028

Conditions
Mild Cognitive ImpairmentDepression
Interventions
DEVICE

Accelerated iTBS

The investigators will treat participants with accelerated intermittent theta burst stimulation. iTBS will be delivered via a MagVenture MagPro TMS System with a Cool-B65 coil, targeting to direct the stimulation to the left dorsolateral prefrontal cortex (l-dlPFC). The investigators will use a standard resting motor threshold (rMT) determination to determine the TMS dose. Treatment will be delivered at 120% of the motor threshold. Total treatment time will be controlled; all participants will perceive receiving active treatment for 10 3-min sessions with 10-15 min inter-session intervals, resulting in a 3-hour treatment day. At pre-treatment, a focal electrical sham will be individually titrated to participant tolerability. Participants then receive an individualized level of sham stimulation throughout treatment, to bolster the blind. Participants will be told that they will be receiving different doses throughout the treatment day, again to maintain the integrity of the blind.

DEVICE

Sham Comparator

To achieve adequate blinding, participants will go through the same number of sessions per day irrespective of the active and/or sham dose-step combination to which they are assigned. Sham sessions will be assigned in random order over the 10 sessions. The sequence of active and/or sham sessions for each treatment day is assigned a random code that is entered into the TMS system by the coordinator to maintain the integrity of the blind.

Trial Locations (1)

29425

RECRUITING

Medical University of South Carolina, Charleston

All Listed Sponsors
collaborator

National Institute on Aging (NIA)

NIH

lead

Medical University of South Carolina

OTHER