TMS for Inhibition Enhancement in Schizophrenia
TIES
Cognitive and Neural Correlates of TMS Motor Intracortical Inhibition in Schizophrenia
1 other identifier
interventional
34
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable schizophrenia
Started Feb 2026
Typical duration for not_applicable schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 22, 2023
CompletedFirst Posted
Study publicly available on registry
December 4, 2023
CompletedStudy Start
First participant enrolled
February 2, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2029
February 13, 2026
February 1, 2026
3.1 years
November 22, 2023
February 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The change in the short interval intracortical inhibition (SICI) score
At baseline, and at the end of 5 days of rTMS treatment, we will perform 24 trials of paired-pulse TMS to calculate SICI score (defined as the ratio of the evoked motor potential to the paired-pulse TMS in our SICI protocol relative to a single suprathreshold pulse). We will average across these 24 trials to get an average SICI score (both pre-TMS and post-TMS). We will calculate the change in SICI score (pre-TMS to post-TMS) for each participant.
one week
Secondary Outcomes (2)
change in motor cortex functional connectivity
one week
change in neurocognitive performance
one week
Study Arms (2)
Active rTMS
ACTIVE COMPARATORmultiple trains of active transcranial magnetic stimulation in a day (using the active TMS coil), for multiple days
sham rTMS
SHAM COMPARATORmultiple trains of sham transcranial magnetic stimulation in a day (using the sham comparator TMS coil), for multiple days
Interventions
non-invasive active repetitive stimulation applied to the scalp surface
non-invasive active repetitive stimulation applied to the scalp surface
Eligibility Criteria
You may qualify if:
- Age 18-45 years
- Male or Female
- Able to participate in the informed consent process and provide voluntary informed consent.
- 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)
You may not qualify if:
- 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.
- A history of a current neurological disorder (including, but not limited to Parkinson's Disease, epilepsy, or Multiple Sclerosis)
- History of head trauma resulting in unconsciousness
- 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
- Contraindications for MRI, including pacemakers or other metal in body
- Suspected DSM-5 intellectual disability based upon clinical interview and psychosocial history
- Pregnancy
- Any change in type of antipsychotic medication in the last 30 days and dose in the last 14 days
- 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
- Prior history of treatment TMS (equivalent to 5 or more sessions of rTMS or theta-burst) in the past 6 months
- 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)
- A score of 7 or more on the Simpson-Angus Scale of Extrapyramidal Symptoms (range 0-52 with higher scores indicating worse extrapyramidal symptoms)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maryland Psychiatric Research Center
Catonsville, Maryland, 21228, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephanie Hare, PhD
University of Maryland, Baltimore
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
November 22, 2023
First Posted
December 4, 2023
Study Start
February 2, 2026
Primary Completion (Estimated)
March 1, 2029
Study Completion (Estimated)
April 1, 2029
Last Updated
February 13, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share