1 Hz rTMS to boost motor-cortex inhibition in people with schizophrenia
Cognitive and Neural Correlates of TMS Motor Intracortical Inhibition in Schizophrenia
We will test whether 1 Hz rTMS applied to the motor cortex can increase brain inhibition in adults with schizophrenia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Locations | 1 site (Catonsville, Maryland) |
| Trial ID | NCT06155682 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–45 with a DSM-5 diagnosis of schizophrenia who can give informed consent and have no contraindications to TMS or MRI are ideal candidates.
Not a fit: People with recent substance misuse, a history of seizures or neurologic disorders, ferromagnetic cranial implants, pacemakers, or other TMS/MRI contraindications, or those outside the 18–45 age range are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, this could provide a noninvasive way to enhance cortical inhibition and potentially improve cognitive control in people with schizophrenia.
How similar studies have performed: Previous rTMS studies have shown modulation of cortical excitability and connectivity, but using 1 Hz rTMS specifically to increase SICI in schizophrenia remains preliminary with limited supporting data.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Catonsville, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.