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rTMS Treatment for Positive and Negative Symptoms of Schizophrenia

Primary Purpose

Schizophrenia

Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
rTMS
Sponsored by
St. Joseph's Healthcare Hamilton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring rTMS

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Joseph's Healthcare HamiltonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

rTMS Treatment

Arm Description

Outcomes

Primary Outcome Measures

Positive and Negative Symptom Scale (PANSS)
semi-structured interview designed to rate the severity of schizophrenia symptoms. Score from 0-231, with higher score being worse.

Secondary Outcome Measures

Beck Depression Inventory
Self-report questionnaire for depression symptoms. Scores range from 0-63, with higher being worse.
Hamilton Depression Rating Scale (HAM-D)
Clinician-rated scale for depression symptoms. Scores range from 0-53, with higher being worse.

Full Information

First Posted
January 17, 2018
Last Updated
April 18, 2019
Sponsor
St. Joseph's Healthcare Hamilton
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1. Study Identification

Unique Protocol Identification Number
NCT03413527
Brief Title
rTMS Treatment for Positive and Negative Symptoms of Schizophrenia
Official Title
Examining the Impact of Transcranial Magnetic Stimulation (rTMS) on Schizophrenia and Related Disorders: A Case Series
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (Actual)
Primary Completion Date
February 2020 (Anticipated)
Study Completion Date
February 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Joseph's Healthcare Hamilton

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
rTMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
rTMS Treatment
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
rTMS
Intervention Description
rTMS Treatment
Primary Outcome Measure Information:
Title
Positive and Negative Symptom Scale (PANSS)
Description
semi-structured interview designed to rate the severity of schizophrenia symptoms. Score from 0-231, with higher score being worse.
Time Frame
Change from pre-treatment to post treatment over 6 weeks
Secondary Outcome Measure Information:
Title
Beck Depression Inventory
Description
Self-report questionnaire for depression symptoms. Scores range from 0-63, with higher being worse.
Time Frame
Change from pre-treatment to post treatment over 6 weeks
Title
Hamilton Depression Rating Scale (HAM-D)
Description
Clinician-rated scale for depression symptoms. Scores range from 0-53, with higher being worse.
Time Frame
change from pre-treatment to post treatment over 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: are voluntary and competent to consent to treatment have a diagnosis of schizophrenia or schizoaffective disorder are between the ages of 18 and 75 are willing and able to adhere to the treatment schedule Pass the TMS adult safety-screening (TASS) questionnaire have normal thyroid functioning based on pre-study blood work. Patients may be reassessed for the study once thyroid levels have normalized. are willing and able to cooperate with interviews and follow simple instructions Exclusion Criteria: do not pass the TASS Safety Screening Questionnaire have a significant history of seizures have active suicidal intent are pregnant or may be pregnant. A pregnancy test will be performed for fertile women. have failed a course of Electroconvulsive Therapy (ECT) in the current or previous episode 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 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 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. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sheila Verhage-Brown, HBSc, MD
Phone
905-522-1155
Ext
36356
Email
sverhage@stjoes.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Chaimowitz, MD, FRCPC
Organizational Affiliation
St. Joseph's Healthcare Hamilton
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N3K7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheila Verhage-Brown, HBSc, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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rTMS Treatment for Positive and Negative Symptoms of Schizophrenia

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