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Recruiting NCT05992831

NCT05992831 Transcranial Magnetic Stimulation for MCI

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Clinical Trial Summary
NCT ID NCT05992831
Status Recruiting
Phase
Sponsor Medical University of South Carolina
Condition Mild Cognitive Impairment
Study Type INTERVENTIONAL
Enrollment 60 participants
Start Date 2024-06-18
Primary Completion 2028-04-30

Trial Parameters

Condition Mild Cognitive Impairment
Sponsor Medical University of South Carolina
Study Type INTERVENTIONAL
Phase N/A
Enrollment 60
Sex ALL
Min Age 60 Years
Max Age 85 Years
Start Date 2024-06-18
Completion 2028-04-30
Interventions
Accelerated iTBSSham Comparator

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Brief 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 Criteria

Inclusion Criteria: i. Age 60-85 (inclusive). ii. English as a first/primary language. iii. Adequate sensorimotor function and verbal expressive abilities to complete all assessments. iv. Must have a Co-Participant (e.g. spouse, adult child or relative, sibling, cohabitator, friend, caregiver) who has at least weekly in-person contact with the participant and is willing to participate in the study as a collateral informant. v. Is on fixed pharmacotherapy (i.e. a stable dose of medication/s) for at least 4 weeks prior to enrollment. Cholinesterase inhibitors, NMDA receptor antagonists, and antidepressants are allowed if on a stable regimen for at least 4 weeks prior to enrollment. Prior treatment with anti-amyloid monoclonal antibody therapy is acceptable if last infusion was at least 8 weeks prior to enrollment. Prior TMS treatment is acceptable if last stimulation session was at least 24 weeks prior to enrollment. vi. A documented diagnosis of MCI per NIA-AA criteria or Mild Neurocogn

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