What this study is
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
What's being tested
- repetitive transcranial magnetic stimulation (active)
Intervention · DEVICE
- repetitive transcranial magnetic stimulation (sham)
Intervention · DEVICE
Both interventions
non-invasive active repetitive stimulation applied to the scalp surface
Study details
- Official title
- Cognitive and Neural Correlates of TMS Motor Intracortical Inhibition in Schizophrenia
- Sponsor
- University of Maryland, Baltimore
- Conditions
- Schizophrenia
- Enrolling
- 34 people
- Starts
- 2026-02-02
- Est. completion
- 2029-04
- Design
- Triple-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 45 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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)
You can't join if
- 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 treatment TMS (equivalent to 5 or more sessions of rTMS or theta-burst) in the past 6 months
- 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)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMaryland Psychiatric Research Center
Catonsville, Maryland, United States
- Stephanie M Hare, PhD · Contact410-402-6119stephanie.hare@som.umaryland.edu
Recruiting
Study team
Sponsor
University of Maryland, Baltimore
Study ID HP-00108871
Principal investigator
Stephanie Hare, PhD
University of Maryland, Baltimore
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.