Cerebellar rTMS for the Treatment of Schizophrenic Patients

Not Applicable

Completed

• Conditions: Schizophrenia
• Interventions: Device: Transcranial magnetic stimulation via MagPro x100 device

• Registration Number: NCT01072617
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Study First Submitted: 2010-02-19
• Study First Submitted QC: 2010-02-19
• Study First Posted: 2010-02-22
• Results First Submitted: 2017-01-20
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-28
• Last Update Submitted: 2017-04-28
• Results First Posted: 2017-06-05
• Last Update Posted: 2017-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Safety of rTMS in schizophrenia patients	Transcranial magnetic stimulation via MagPro x100 device	Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days

Primary Outcome Measures

Name	Time	Method
Adverse Events	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

Name	Time	Method
Positive and Negative Syndrome Scale (PANSS) - Negative Subscale	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.
Positive and Negative Syndrome Scale (PANSS) - Positive Subscale	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.
Positive and Negative Syndrome Scale (PANSS) - General Subscale	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.

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States