Cerebellar rTMS for the Treatment of Schizophrenic Patients

Schizophrenia Clinical Trial

Official title:

Safety and Therapeutic Efficacy of Cerebellar Repetitive Transcranial Magnetic Stimulation in Patients With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01072617
• Other study ID #: 2007P-000395
• Status: Completed
• Phase: N/A
• First received: February 19, 2010
• Last updated: February 3, 2015
• Start date: February 2008
• Est. completion date: April 2009

Study information

• Verified date: February 2015
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Potential adverse events to the intervention	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. Blood pressure monitoring at baseline and twice daily for 5 days pre and post treatment and at 1 week follow up. Cerebellar exam at baseline, at the end of every treatment day for 5 days and at the 1 week follow up.Pain assessment with a visual analogue scale twice a day, every day for 5 days of treatment	3 weeks	Yes
Secondary	Assess potential therapeutic efficacy	Therapeutic efficacy assessed at baseline, the end of 1 week of treatment and at the end at 1 week following completion of treatment. Efficacy will be evaluated with the Positive and Negative Symptoms scale and with neuropsychological testing	3 weeks	No