Cerebellar rTMS for the Treatment of Schizophrenic Patients

This study has been completed.
Sponsor:
Collaborator:
Massachusetts Department of Mental Health Central Office Research Review Committee
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01072617
First received: February 19, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Device: MagPro X100 rTMS Machine
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Enrollment: 20
Study Start Date: February 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Safety of rTMS in schizophrenia patients Device: MagPro X100 rTMS Machine

To maximize the efficacy, participants will receive 10 rTMS sessions to the vermis (lobule VII) of cerebellum. 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 a figure of 8, double-cone-shaped coil by positioning the stimulation coil over the appropriate position on the subject's scalp. rTMS, with the intermittent theta burst pattern (iTBS) (20 trains of 10 bursts given with 8-s intervals), will be applied at 80% of active motor threshold. These parameters are known to cause excitation in brain activity. Each participant will receive 600 pulses per session. The size of the brain area that is stimulated is about 2 x 2.5 cm and is expected to reach the vermis area.

Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system.


  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01072617

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Massachusetts Department of Mental Health Central Office Research Review Committee
  More Information

No publications provided

Responsible Party: Alvaro Pascual-Leone, MD, PhD, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01072617     History of Changes
Other Study ID Numbers: 2007P-000395
Study First Received: February 19, 2010
Last Updated: February 19, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014