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TMS for Inhibition Enhancement in Schizophrenia

Cognitive and Neural Correlates of TMS Motor Intracortical Inhibition in Schizophrenia

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 45 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small study tests whether repeated magnetic pulses to the brain (rTMS) can help the brain slow down its signals. It is for 34 adults ages 18–45 with schizophrenia. Researchers will also study changes in brain connections and thinking skills.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18–45 years old.
  • You are male or female.
  • You can understand the study and freely agree to take part.
  • You have schizophrenia, confirmed through a structured mental health interview.

Who can't join

  • You had a substance use disorder in the past 6 months, except for caffeine, tobacco, or mild marijuana misuse; or your starting urine drug test is positive.
  • You have a current brain or nerve disorder, such as Parkinson’s disease, epilepsy, or multiple sclerosis; a past head injury that made you pass out; or a suspected intellectual disability that affects learning and understanding.
  • TMS or MRI is unsafe for you. Reasons include past seizures other than fever-related seizures, magnetic metal in your skull, a hearing implant, deep brain stimulation wires, a pacemaker, or other metal in your body.
  • You are pregnant.
  • Your antipsychotic medicine type changed in the past 30 days or its dose changed in the past 14 days. You also cannot take any anti-seizure medicine or a benzodiazepine at a dose equal to at least 2 mg of lorazepam per day.
  • You had 5 or more sessions of rTMS or theta-burst TMS treatment in the past 6 months.
  • Your suicide screening shows active thoughts of suicide involving a method, intent, or plan, or any listed suicide-related behavior, such as an attempt or steps to prepare for one.
  • You score 7 or higher on the Simpson-Angus Scale, which measures movement symptoms.

Simplified for readability. The official criteria below are what the study team uses.

Official 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)

Study sites (1)

MD