NCT06155682 TMS for Inhibition Enhancement in Schizophrenia
| NCT ID | NCT06155682 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Maryland, Baltimore |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 34 participants |
| Start Date | 2026-02-02 |
| Primary Completion | 2029-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 34 participants in total. It began in 2026-02-02 with a primary completion date of 2029-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 inhibitory 1 Hertz (Hz) rTMS targeting motor cortex can increase brain inhibition reflected in a decrease in the short-interval intracortical inhibition (SICI) score from pre-to-post-treatment. We will also collect preliminary data on the effect of rTMS on the resting functional connectivity of the motor cortex and other brain regions and the relationship of change in SICI to change in cognitive performance
Eligibility Criteria
Inclusion Criteria: 1. Age 18-45 years 2. Male or Female 3. Able to participate in the informed consent process and provide voluntary informed consent. 4. 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 Criteria: 1. 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. 2. A history of a current neurological disorder (including, but not limited to Parkinson's Disease, epilepsy, or Multiple Sclerosis) 3. History of head trauma resulting in unconsciousness 4. 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 5. Contraindications for MRI, including pacemakers or other metal in body 6. Suspected DSM-5 intellectual disability based upon clinical interview and psychosocial history 7. Pregnancy 8. Any change in type of antipsychotic medication in the last 30 days and dose in the last 14 days 9. 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 10. Prior history of treatment TMS (equivalent to 5 or more sessions of rTMS or theta-burst) in the past 6 months 11. 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) 12. A score of 7 or more on the Simpson-Angus Scale of Extrapyramidal Symptoms (range 0-52 with higher scores indicating worse extrapyramidal symptoms)
Contact & Investigator
Stephanie Hare, PhD
PRINCIPAL INVESTIGATOR
University of Maryland, Baltimore
Frequently Asked Questions
Who can join the NCT06155682 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06155682 currently recruiting?
Yes, NCT06155682 is actively recruiting participants. Contact the research team at stephanie.hare@som.umaryland.edu for enrollment information.
Where is the NCT06155682 trial being conducted?
This trial is being conducted at Catonsville, United States.
Who is sponsoring the NCT06155682 clinical trial?
NCT06155682 is sponsored by University of Maryland, Baltimore. The principal investigator is Stephanie Hare, PhD at University of Maryland, Baltimore. The trial plans to enroll 34 participants.
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