TMS for Inhibition Enhancement in Schizophrenia

NCT ID: NCT06155682

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2029-04-30

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

Detailed Description

This study is a randomized double blind clinical trial being funded by the National Institute of Mental Health (NIMH). The primary aim is to estimate feasibility and tolerability of a 5-day, 1Hz rTMS intervention in 34 participants with schizophrenia. A secondary aim is to assess target engagement by investigating whether 1 Hz rTMS applied to motor cortex can enhance intracortical inhibition in participants with schizophrenia. The participants with Sz will be randomized in a 1:1 ratio to either active 1Hz rTMS or sham 1Hz rTMS. We do not necessarily anticipate a statistically significant difference between treatment groups, given our limited sample size. Rather, we are focused on generating effect size estimates that will help us determine whether and how to proceed to the next phase of research and a future R01 submission. We will explore the relationship between change in SICI score (pre-to-post-treatment) and total scores of clinical scales (Fagerstrom nicotine dependence, the brief psychiatric rating scale and the brief negative symptoms scale) and medication dose and type. We will also collect preliminary data on the effect of rTMS on the resting state functional connectivity of the motor cortex with other brain regions, and the change performance on cognitive tasks (i.e., stop signal reaction time, spatial working memory) from pre-to-post-treatment.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Active rTMS

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

Group Type: ACTIVE_COMPARATOR

repetitive transcranial magnetic stimulation (active)

Intervention Type: DEVICE

non-invasive active repetitive stimulation applied to the scalp surface

sham rTMS

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

Group Type: SHAM_COMPARATOR

repetitive transcranial magnetic stimulation (sham)

Intervention Type: DEVICE

non-invasive active repetitive stimulation applied to the scalp surface

Interventions

repetitive transcranial magnetic stimulation (active)

non-invasive active repetitive stimulation applied to the scalp surface

Intervention Type: DEVICE

repetitive transcranial magnetic stimulation (sham)

non-invasive active repetitive stimulation applied to the scalp surface

Intervention Type: DEVICE

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 rTMS treatment in the past 5 years

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Stephanie Hare

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephanie Hare, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Central Contacts

Stephanie Hare, PhD

Role: CONTACT

stephanie.hare@som.umaryland.edu

410-402-6119

Jennifer Zaranski

Role: CONTACT

jzaranski@som.umaryland.edu

Related Links

http://www.mprc.umaryland.edu

Maryland Psychiatric Research Center

Other Identifiers

HP-00108871

Identifier Type: -

Identifier Source: org_study_id