Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06155682
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-28
First Post:
2023-11-22
Brief Title:
TMS for Inhibition Enhancement in Schizophrenia
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Cognitive and Neural Correlates of TMS Motor Intracortical Inhibition in Schizophrenia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TIES
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 11 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 ie stop signal reaction time spatial working memory from pre-to-post-treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None