Clinical trial NCT01072617: Cerebellar rTMS for the Treatment of Schizophrenic Patients
Official title: Safety and Therapeutic Efficacy of Cerebellar Repetitive Transcranial Magnetic Stimulation in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2010-02-22
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Adverse Events
timeFrame: 3 weeks
Secondary outcomes:
measure: Positive and Negative Syndrome Scale (PANSS) - Positive Subscale
timeFrame: Baseline, 5 days (post-treatment), 1 week post treatment
measure: Positive and Negative Syndrome Scale (PANSS) - Negative Subscale
timeFrame: Baseline, 5 days (post-treatment), 1 week post treatment
measure: Positive and Negative Syndrome Scale (PANSS) - General Subscale
timeFrame: Baseline, 5 days (post-treatment), 1 week post treatment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Alvaro Pascual-Leone, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: