NCT06155682

TMS for Inhibition Enhancement in Schizophrenia

Cognitive and Neural Correlates of TMS Motor Intracortical Inhibition in Schizophrenia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	repetitive transcranial magnetic stimulation (active)	non-invasive active repetitive stimulation applied to the scalp surface
DEVICE	repetitive transcranial magnetic stimulation (sham)	non-invasive active repetitive stimulation applied to the scalp surface

Timeline

• Start date: 2026-02-02
• Primary completion: 2029-03-01
• Completion: 2029-04-01
• First posted: 2023-12-04
• Last updated: 2026-02-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study