Status:
NOT_YET_RECRUITING
TMS for Inhibition Enhancement in Schizophrenia
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Schizophrenia
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
This study purpose is to perform a pilot mechanistic trial repetitive transcranial magnetic stimulation (rTMS) clinical trial in 34 people with schizophrenia (Sz). The trial will evaluate whether inhi...
Detailed Description
This study is a randomized double blind clinical trial being funded by the National Institute of Mental Health (NIMH). The primary aim is to estimate feasibility and tolerability of a 5-day, 1Hz rTMS ...
Eligibility Criteria
Inclusion
- Age 18-45 years
- Male or Female
- Able to participate in the informed consent process and provide voluntary informed consent.
- A Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) diagnosis of schizophrenia documented by the Structured Clinical Interview for DSM-5 (SCID-5)
Exclusion
- A history of a DSM-5 substance misuse disorder (other than caffeine or tobacco or mild marijuana misuse) within the past six months; or a positive baseline urine drug screen.
- A history of a current neurological disorder (including, but not limited to Parkinson's Disease, epilepsy, or Multiple Sclerosis)
- History of head trauma resulting in unconsciousness
- Contraindications for TMS, including any history of seizure other than febrile seizure, presence of ferromagnetic metal in cranium, presence of cochlear implant, presence of deep brain stimulation (DBS) electrodes based on medical history
- Contraindications for MRI, including pacemakers or other metal in body
- Suspected DSM-5 intellectual disability based upon clinical interview and psychosocial history
- Pregnancy
- Any change in type of antipsychotic medication in the last 30 days and dose in the last 14 days
- Treatment with a benzodiazepine with a dose equivalent to lorazepam 2 mg/day or greater or any anticonvulsant due to the potential of these medications to affect TMS SICI score and the efficacy of rTMS
- Prior history of rTMS treatment in the past 5 years
- Endorsement of active suicidal ideation on the Columbia-Suicide Severity Rating Scale (version: last 30 days) reflected by "yes" response on items 3, 4, or 5 of the ideation questions and/or "yes" to any of the four suicidal behavior items (actual attempt, interrupted attempt, aborted attempt, preparatory acts/behavior)
- A score of 7 or more on the Simpson-Angus Scale of Extrapyramidal Symptoms (range 0-52 with higher scores indicating worse extrapyramidal symptoms)
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2029
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT06155682
Start Date
November 1 2025
End Date
April 1 2029
Last Update
May 20 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.