Accelerated Repetitive TMS for Affective Dysfunction: Establishing the Dose-Response Curve

Purpose:

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.

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 - renal - gastrointestinal - pulmonary - metabolic - endocrine - other - 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: - vascular - Alzheimer's disease - other types - Repeated abuse or dependence upon drugs (excluding nicotine and caffeine) within 6 days of study entry, with the exception of alcohol use disorder, which, at the discretion of the study team, may be permitted. See further explanation under protection from risk. - Active participation or plan for enrollment in another evidence-based psychotherapeutic clinical trial - Participation in other psychotherapeutic modalities must have been stable for 3 months prior to enrollment and must remain stable throughout participation. - Currently taking medications that have short half-lives, lower the seizure threshold, and do not have evidence of antidepressant efficacy. These include: - high dose theophylline or stimulants such as methylphenidate patients taking bupropion must be on a stable dose and take less than or equal to 300 mg/day. Stable means the same dose for 5 half-lives. - An implanted device in subject's head (shunt, cochlear implant) and/or metal in subject's head (other than dental implant). - History of seizures or a seizure disorder.

Study is Available At:

Original ID:

00084111

NCT ID:

NCT04657432

Secondary ID:

Study Acronym:

Brief Title:

Brief, High-dose rTMS for Depression

Official Title:

Accelerated Repetitive TMS for Affective Dysfunction: Establishing the Dose-Response Curve

ClinicalTrials.gov Link:

https://clinicaltrials.gov/show/NCT04657432

Overall Status:

Recruiting

Study Phase:

N/A

Genders:

N/A

Minimum Age:

18 Years

Maximum Age:

60 Years

Study Source:

Medical University of South Carolina

Oversight Authority:

There was an error processing this request

Reasons Why Stopped:

Study Type:

Interventional

Study Design:

Number of Arms:

11

Number of Groups:

0

Total Enrollment:

100

Enrollment Type:

Anticipated

Data Source: ClinicalTrials.gov

Date Processed: August 16, 2022

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