High-dose rTMS treatment for depression
Accelerated Repetitive TMS for Affective Dysfunction: Establishing the Dose-Response Curve
This study is testing whether a high-dose brain stimulation treatment can help people with major depression and anxiety feel better and how different brain patterns might affect the results.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT04657432 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of high-frequency repetitive transcranial magnetic stimulation (rTMS) on patients with major depression and anxiety. It aims to establish a dose-response relationship for an accelerated protocol known as intermittent theta burst stimulation (iTBS) and assess how individual variations in brain networks influence treatment outcomes. Participants will undergo rTMS sessions while their clinical symptoms are monitored to evaluate the effectiveness of this innovative approach.
Who should consider this trial
Good fit: Ideal candidates include adults with major depression who are able to comply with study protocols and have no contraindicating medical conditions.
Not a fit: Patients with severe psychiatric disorders, unstable medical conditions, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a rapid and effective option for patients suffering from depression and anxiety.
How similar studies have performed: Previous studies have shown promise with rTMS, but this specific accelerated protocol is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Claire Cox, BA
- Email: coxcl@musc.edu
- Phone: (843)792-6282
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.