Cerebellar rTMS for the Treatment of Schizophrenic Patients

Study Overview
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Brief Summary
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The primary aim of this protocol is to determine whether the use of repetitive transcranial magnetic stimulation (rTMS) over vermis of the cerebellum may be safe and therapeutically effective in patients with schizophrenia. Because this is the first evaluation of this treatment in this population, the focus of this study is safety.

Official Title
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Safety and Therapeutic Efficacy of Cerebellar Repetitive Transcranial Magnetic Stimulation in Patients With Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Device: Transcranial magnetic stimulation via MagPro x100 device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18-65 years Diagnosis of schizophrenia according to DSM-IV criteria(by a board-certified psychiatrist) Exclusion Criteria: Prior neurosurgical procedures Any history of seizure Previous head injury Contraindication to TMS: Implanted pacemaker Medication pump Vagal stimulator Deep brain stimulator Metallic hardware in the head or scalp: shrapnel, surgical clips, or fragments from welding Signs of increased intracranial pressure TENS unit and ventriculo-peritoneal shunt Pregnancy or lactating; note that a negative pregnancy test will be required if the patient is a female in reproductive years Advanced liver, kidney, cardiac, or pulmonary disease as defined clinically or a terminal medical diagnosis consistent with survival < 1 year A history of significant alcohol or drug abuse in the prior six months No focal cortical insult can be present, including tumor or vascular malformation Patients may not be actively enrolled in a separate intervention study Patients unable to undergo a brain MR: a. claustrophobia refractory to anxiolytics ferromagnetic metal in the body such as a prosthetic heart valve, a pacemaker, or a brain aneurysm clip). Change in antipsychotic medication during the last 4 weeks Any emergency psychiatry department visit during the last 4 weeks Been an inpatient in a psychiatry clinic within the last month Any other axis I diagnosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Safety of rTMS in schizophrenia patients<br>Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days | Device: Transcranial magnetic stimulation via MagPro x100 device<br>* Participants will receive 10 repetitive transcranial magnetic stimulation sessions to the vermis of cerebellum using the MagPro x100 TMS device. These 10 rTMS sessions will be administered from Monday to Friday in five days, twice a day with a minimum of 4-hour gap between the sessions. Repetitive TMS will be applied with the intermittent theta burst pattern (iTBS). These parameters are known to cause excitation in brain activity. Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Adverse event collection at baseline, daily for 5 days during treatment, every other day by phone until the final assessment at week 1 follow up visit. | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive and Negative Syndrome Scale (PANSS) - Positive Subscale | Potential therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) Positive Subscale, a 7 item subscale measuring the presence/absence and severity of positive symptoms of schizophrenia. The minimum score is 7 and the maximum score is 49, with higher values representing greater symptom severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, and 1 week post treatment. The overall PANSS total score (minimum = 30, maximum = 210) is computed by summing the positive, negative, and general subscales; and higher values represent more severe schizophrenia psychopathology. | Baseline, 5 days (post-treatment), 1 week post treatment | 
| Positive and Negative Syndrome Scale (PANSS) - Negative Subscale | Potential therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) Negative Subscale, a 7 item subscale measuring the presence/absence and severity of negative symptoms of schizophrenia. The minimum score is 7 and the maximum score is 49, with higher values representing greater symptom severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, and 1 week post treatment. The overall PANSS total score (minimum = 30, maximum = 210) is computed by summing the positive, negative, and general subscales; and higher values represent more severe schizophrenia psychopathology. | Baseline, 5 days (post-treatment), 1 week post treatment | 
| Positive and Negative Syndrome Scale (PANSS) - General Subscale | Potential therapeutic efficacy was evaluated with the Positive and Negative Syndrome Scale (PANSS) General Subscale, a 16 item subscale measuring the presence/absence and severity of general psychopathology of schizophrenia. The minimum score is 16 and the maximum score is 112, with higher values representing greater psychopathology severity. Therapeutic efficacy was assessed at baseline, after 5 days of treatment, and 1 week post treatment. The overall PANSS total score (minimum = 30, maximum = 210) is computed by summing the positive, negative, and general subscales; and higher values represent more severe schizophrenia psychopathology. | Baseline, 5 days (post-treatment), 1 week post treatment |