TMS for Inhibition Enhancement in Schizophrenia

Status Not yet recruiting

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Schizophrenia

Clinical Trial Details

NCT number	NCT06155682
Study type	Interventional
Source	University of Maryland, Baltimore
Contact	Stephanie Hare, PhD
Phone	410-402-6119
Email	stephanie.hare@som.umaryland.edu
Status	Not yet recruiting
Phase	N/A
Start date	March 2025
Completion date	December 2028

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

TMS for Inhibition Enhancement in Schizophrenia — TIES

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms