1 Hz rTMS to boost motor-cortex inhibition in people with schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind pilot trial will enroll 34 adults with schizophrenia who are randomized 1:1 to active or sham 1 Hz rTMS targeting the motor cortex. Treatments are delivered over five consecutive days with pre- and post-treatment measurement of short-interval intracortical inhibition (SICI). The study will also collect resting-state fMRI to examine changes in motor cortex connectivity and will measure cognitive performance (stop-signal reaction time, spatial working memory) and clinical scales. The primary aims are to estimate feasibility and tolerability and to generate effect size estimates for target engagement.

Why it matters

Who can join: the full rules

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)

Where it's running

• Maryland Psychiatric Research Center
  Catonsville, Maryland, United States Recruiting

Study contacts

• Principal investigator: Stephanie Hare, PhD — University of Maryland, Baltimore
• Study coordinator: Stephanie Hare, PhD
• Email: stephanie.hare@som.umaryland.edu
• Phone: 410-402-6119

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.