RECRUITINGINTERVENTIONAL
TMS for Inhibition Enhancement in Schizophrenia
Cognitive and Neural Correlates of TMS Motor Intracortical Inhibition in Schizophrenia
About This Trial
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
Who May Be Eligible (Plain English)
Who May Qualify:
1. Age 18-45 years
2. Male or Female
3. Able to participate in the willing to sign a consent form process and provide voluntary willing to sign a consent form.
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)
Who Should NOT Join This Trial:
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 treatment TMS (equivalent to 5 or more sessions of rTMS or theta-burst) in the past 6 months
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)
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Original Eligibility Criteria
View original clinical language
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 treatment TMS (equivalent to 5 or more sessions of rTMS or theta-burst) in the past 6 months
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)
Treatments Being Tested
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
Locations (1)
Maryland Psychiatric Research Center
Catonsville, Maryland, United States