Brief, High-dose rTMS for Depression
Running, not enrolling · Not applicable
Conditions studied: Depression, Anxiety
In brief
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.
Key facts
- Study ID
- NCT04657432
- Run by
- Medical University of South Carolina
- People needed
- 70
- Starts
- 2021-05-25
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-04-02
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Medical University of South Carolina — Charleston, South Carolina, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.