rTMS Treatment for Positive and Negative Symptoms of Schizophrenia

NCT ID: NCT03413527

Last Updated: 2019-04-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2020-02-29

Brief Summary

This study will examine the effects of rTMS on the negative and positive symptoms of schizophrenia using 2 treatments in sequence applied to related brain areas.

Conditions

Schizophrenia

Study Design

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

Study Groups

rTMS Treatment

Group Type: EXPERIMENTAL

rTMS

Intervention Type: DEVICE

rTMS Treatment

Interventions

rTMS

rTMS Treatment

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. are voluntary and competent to consent to treatment

2. have a diagnosis of schizophrenia or schizoaffective disorder

3. are between the ages of 18 and 75

4. are willing and able to adhere to the treatment schedule

5. Pass the TMS adult safety-screening (TASS) questionnaire

6. have normal thyroid functioning based on pre-study blood work. Patients may be reassessed for the study once thyroid levels have normalized.

7. are willing and able to cooperate with interviews and follow simple instructions

Exclusion Criteria

1. do not pass the TASS Safety Screening Questionnaire

2. have a significant history of seizures

3. have active suicidal intent

4. are pregnant or may be pregnant. A pregnancy test will be performed for fertile women.

5. have failed a course of Electroconvulsive Therapy (ECT) in the current or previous episode

6. have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure except those therapeutically induced by ECT, cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis, or head trauma resulting in loss of consciousness greater than or equal to 5 minutes

7. have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed

8. have had changes in dose or initiation of any psychotropic medication in the 4 weeks prior to screening. Patients may be re-screened once medications have been stable for 4 weeks.

9. currently (or in the last 4 weeks) take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role: lead

Responsible Party

Gary Chaimowitz

Principal Investigator, Head of Forensics Service

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gary Chaimowitz, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

St. Joseph's Healthcare Hamilton

Locations

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Sheila Verhage-Brown, HBSc, MD

Role: CONTACT

sverhage@stjoes.ca

905-522-1155 ext. 36356

Facility Contacts

Sheila Verhage-Brown, HBSc, MD

Role: primary

Other Identifiers

3864

Identifier Type: -

Identifier Source: org_study_id