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Cerebellar rTMS for the Treatment of Schizophrenic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01072617
Recruitment Status : Completed
First Posted : February 22, 2010
Results First Posted : June 5, 2017
Last Update Posted : June 5, 2017
Sponsor:
Information provided by (Responsible Party):
Alvaro Pascual-Leone, Beth Israel Deaconess Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Schizophrenia Device: Transcranial magnetic stimulation via MagPro x100 device Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Therapeutic Efficacy of Cerebellar Repetitive Transcranial Magnetic Stimulation in Patients With Schizophrenia
Study Start Date : February 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Safety of rTMS in schizophrenia patients
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

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.


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 3 weeks ]
    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.


Secondary Outcome Measures :
  1. Positive and Negative Syndrome Scale (PANSS) - Positive Subscale [ Time Frame: Baseline, 5 days (post-treatment), 1 week post treatment ]
    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.

  2. Positive and Negative Syndrome Scale (PANSS) - Negative Subscale [ Time Frame: Baseline, 5 days (post-treatment), 1 week post treatment ]
    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.

  3. Positive and Negative Syndrome Scale (PANSS) - General Subscale [ Time Frame: Baseline, 5 days (post-treatment), 1 week post treatment ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01072617


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Alvaro Pascual-Leone, MD, PhD Beth Israel Deaconess Medical Center
More Information
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Responsible Party: Alvaro Pascual-Leone, Professor of Neurology, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01072617    
Other Study ID Numbers: 2007P000395
First Posted: February 22, 2010    Key Record Dates
Results First Posted: June 5, 2017
Last Update Posted: June 5, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders