Schizophrenia Clinical Trial
Official title:
Safety and Therapeutic Efficacy of Cerebellar Repetitive Transcranial Magnetic Stimulation in Patients With Schizophrenia
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | April 2009 |
Est. primary completion date | April 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Age between 18-65 years 2. Diagnosis of schizophrenia according to DSM-IV criteria(by a board-certified psychiatrist) Exclusion Criteria: 1. Prior neurosurgical procedures 2. Any history of seizure 3. Previous head injury 4. Contraindication to TMS: 1. Implanted pacemaker 2. Medication pump 3. Vagal stimulator 4. Deep brain stimulator 5. Metallic hardware in the head or scalp: shrapnel, surgical clips, or fragments from welding 6. Signs of increased intracranial pressure 5. TENS unit and ventriculo-peritoneal shunt 6. Pregnancy or lactating; note that a negative pregnancy test will be required if the patient is a female in reproductive years 7. Advanced liver, kidney, cardiac, or pulmonary disease as defined clinically or a terminal medical diagnosis consistent with survival < 1 year 8. A history of significant alcohol or drug abuse in the prior six months 9. No focal cortical insult can be present, including tumor or vascular malformation 10. Patients may not be actively enrolled in a separate intervention study 11. 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). 12. Change in antipsychotic medication during the last 4 weeks 13. Any emergency psychiatry department visit during the last 4 weeks 14. Been an inpatient in a psychiatry clinic within the last month 15. Any other axis I diagnosis |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Beth Israel Deaconess Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Potential adverse events to the intervention | 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. Blood pressure monitoring at baseline and twice daily for 5 days pre and post treatment and at 1 week follow up. Cerebellar exam at baseline, at the end of every treatment day for 5 days and at the 1 week follow up.Pain assessment with a visual analogue scale twice a day, every day for 5 days of treatment | 3 weeks | Yes |
Secondary | Assess potential therapeutic efficacy | Therapeutic efficacy assessed at baseline, the end of 1 week of treatment and at the end at 1 week following completion of treatment. Efficacy will be evaluated with the Positive and Negative Symptoms scale and with neuropsychological testing | 3 weeks | No |
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