Recruiting

rTMS

Sponsor:

University of Maryland, Baltimore

Code:

NCT06155682

Conditions

Schizophrenia

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

repetitive transcranial magnetic stimulation (active)

repetitive transcranial magnetic stimulation (sham)

Study Details

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

Conditions

Schizophrenia

Study ID

NCT06155682

Start date

Feb 2, 2026

Status verified date

Feb, 2026

Completion date

Apr, 2029

Anticipated

Primary completion date

Mar, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

34 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Active rTMS

multiple trains of active transcranial magnetic stimulation in a day (using the active TMS coil), for multiple days

sham comparator: sham rTMS

multiple trains of sham transcranial magnetic stimulation in a day (using the sham comparator TMS coil), for multiple days

Interventions

repetitive transcranial magnetic stimulation (active)

non-invasive active repetitive stimulation applied to the scalp surface

repetitive transcranial magnetic stimulation (sham)

non-invasive active repetitive stimulation applied to the scalp surface

Primary outcome measure

  • The change in the short interval intracortical inhibition (SICI) score [ Time Frame: one week ]

Central Contacts and Locations

Central contacts

Locations

Maryland Psychiatric Research Center

Recruiting

Catonsville, Maryland, United States, 21228

Contacts

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Feb 13, 2026

Last verified

Feb, 2026

Keywords

  • TMS
  • brain inhibition
  • SICI
  • schizophrenia
  • fMRI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-02-13.