Cerebellar rTMS for the Treatment of Schizophrenic Patients

Beth Israel Lahey Health

Status: Completed

Conditions: Schizophrenia

Treatments: Device: Transcranial magnetic stimulation via MagPro x100 device

Study type: Interventional

Funder types: Other

Identifiers

NCT01072617

2007P000395

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Safety of rTMS in schizophrenia patients

Experimental group

Description:

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

Treatment:

Device: Transcranial magnetic stimulation via MagPro x100 device