Accelerated Repetitive TMS for Affective Dysfunction: Establishing the Dose-Response Curve
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Depression
- Sponsor
- Medical University of South Carolina
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Depression severity (change in score)
- Status
- Active, not recruiting
- Last Updated
- 5 months ago
Overview
Brief Summary
High frequency repetitive transcranial magnetic stimulation (rTMS) has been shown to be safe, feasible, and acceptable. Conventionally, rTMS investigations have relied on rational decision trees for dosage determination. The purpose of this study is to systematically examine an accelerated protocol of intermittent theta burst (iTBS). Study 1 aims to provide a quantifiable dose-response curve for iTBS and depressive symptom reduction in major depression. Study 2 aims to determine the role of individual variations of their functional networks compared to the site of stimulation and clinical outcomes.
Investigators
Eligibility Criteria
Inclusion Criteria
- •A negative urine pregnancy test, if female subject of childbearing potential.
- •Able to speak English and complete study forms, adhere to treatment regimens, and be willing to return for regular visits.
- •After full explanation of the study, willingness of participant is demonstrated by signing the informed consent form.
Exclusion Criteria
- •Clinically unstable medical disease:
- •cardiovascular
- •gastrointestinal
- •pulmonary
- •metabolic
- •endocrine
- •CNS disease deemed progressive
- •Moderate or severe traumatic brain injury (TBI)
- •Pregnant females or those currently breast-feeding.
- •Current or history of schizophrenia or other psychotic disorder, except psychosis not otherwise specified (NOS) when the presence of sensory hallucinations is clearly related to the subject's trauma, Bipolar Type I disorder, or dementia:
Outcomes
Primary Outcomes
Depression severity (change in score)
Time Frame: Day 1, post-treatment point of 1 month
Depression severity as assessed by: 3\. Beck Depression Inventory-II (BDI-II) Rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63.
Secondary Outcomes
- Comorbid symptom severity, functional impairment, acceptability, and tolerability(Day 1, post-treatment point of 1 month)