Cerebellar rTMS for the Treatment of Schizophrenic Patients

NCT ID: NCT01072617

Last Updated: 2017-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2009-04-30

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Transcranial magnetic stimulation via MagPro x100 device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Alvaro Pascual-Leone

Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alvaro Pascual-Leone, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2007P000395

Identifier Type: -

Identifier Source: org_study_id