RecruitingNot ApplicableNCT05992831

Transcranial Magnetic Stimulation for MCI

Transcranial Magnetic Stimulation for MCI: A Phase II Dose-Response Study

Sponsor

Medical University of South Carolina

Enrollment

60 participants

Start Date

Jun 18, 2024

Study Type

INTERVENTIONAL

Conditions

Depression Mild Cognitive Impairment

Summary

The goal of this phase II study is to establish the dose-response curves of a safe and clinically feasible non-invasive brain stimulation technique (accelerated Transcranial Magnetic Stimulation (TMS)) to improve both depression and cognitive function in Mild Cognitive Impairment (MCI) patients with comorbid depression. It is known that TMS can effectively treat depression. Identifying the right dose of accelerated TMS in MCI patients is necessary prior to designing subsequent trials to determine efficacy. These results will inform future clinical trials of accelerated TMS for MCI, with the long-term goal of developing an efficacious treatment to prevent dementia.

Eligibility

Min Age: 60 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether repetitive transcranial magnetic stimulation (rTMS — a non-invasive procedure that uses magnetic pulses to stimulate the brain) can help people with mild cognitive impairment (MCI), which is early memory and thinking difficulties that can lead to dementia. **You may be eligible if...** - You are between 60 and 85 years old - English is your first or primary language - You have been diagnosed with mild cognitive impairment (MCI) - You have a close person (spouse, family member, or friend) who sees you at least once a week and can act as a study companion - You are on a stable medication dose **You may NOT be eligible if...** - You are outside the 60–85 age range - You do not have a close contact able to participate - You have conditions that affect your ability to communicate or complete assessments Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAccelerated 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.

DEVICESham 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.