ACTIVE_NOT_RECRUITING

Brief, High-dose rTMS for Depression

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-05-25

Study Completion:2025-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04657432

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	* 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. * 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.

Inclusion Criteria

Exclusion 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.

* 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.
* 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.

Contacts and Locations

Study Locations (Sites)

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-25

Study Completion Date2025-12-01

Study Record Updates

Study Start Date2021-05-25

Study Completion Date2025-12-01

Terms related to this study

Additional Relevant MeSH Terms

Depression
Anxiety