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Cerebellar rTMS for the Treatment of Schizophrenic Patients

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial magnetic stimulation via MagPro x100 device
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Safety of rTMS in schizophrenia patients

Arm Description

Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
February 19, 2010
Last Updated
April 28, 2017
Sponsor
Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01072617
Brief Title
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

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Safety of rTMS in schizophrenia patients
Arm Type
Experimental
Arm Description
Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days
Intervention Type
Device
Intervention Name(s)
Transcranial magnetic stimulation via MagPro x100 device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adverse Events
Description
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.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale (PANSS) - Positive Subscale
Description
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.
Time Frame
Baseline, 5 days (post-treatment), 1 week post treatment
Title
Positive and Negative Syndrome Scale (PANSS) - Negative Subscale
Description
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.
Time Frame
Baseline, 5 days (post-treatment), 1 week post treatment
Title
Positive and Negative Syndrome Scale (PANSS) - General Subscale
Description
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.
Time Frame
Baseline, 5 days (post-treatment), 1 week post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alvaro Pascual-Leone, MD, PhD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Cerebellar rTMS for the Treatment of Schizophrenic Patients

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