Status:
COMPLETED
rTMS for Emotional Difficulties in Verterans
Lead Sponsor:
VA Office of Research and Development
Conditions:
Mental Health
Depression
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
Mental illness rarely occurs as a single, easily categorized condition. Instead, multiple disorders often co-occur. This complicates the treatment plan for many Veterans, especially those suffering th...
Detailed Description
The investigators propose that because rTMS to dlPFC is targeting cognitive neurocircuitry integral to adaptive cognitive functioning, promoting neuroplasticity in this network with rTMS could be more...
Eligibility Criteria
Inclusion
- 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
- Clinically unstable medical disease:
- cardiovascular
- renal
- gastrointestinal
- pulmonary
- metabolic
- endocrine
- other
- CNS disease deemed progressive
- Moderate or severe traumatic brain injury (TBI) - (using VA/DoD Clinical Practice Guidelines)
- 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.
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2023
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03749967
Start Date
February 1 2019
End Date
October 28 2023
Last Update
November 9 2023
Active Locations (1)
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1
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, United States, 29401-5703