Back to resultsThe Effect of Rapid Transcranial Magnetic Stimulation (rTMS) on Aggression in Forensic Patients
Primary Purpose
Aggression
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
rTMS
Sponsored by
About this trial
This is an interventional treatment trial for Aggression focused on measuring rTMS, Repetitive Transcranial Magnetic Stimulation, Brain Stimulation
Eligibility Criteria
Inclusion Criteria:
- are voluntary and competent to consent to treatment
- are a current Forensics inpatient at St. Joseph's West 5th Campus
- demonstrate aggressive behavior as confirmed by a psychologist or psychiatrist including verbal and physical aggression
- are between the ages of 18 and 65
- have had no changes in dose or initiation of any psychotropic medication in the 4 weeks prior to motor threshold
- are willing and able to adhere to the treatment schedule
- pass the TMS adult Safety-Screening (TASS) Questionnaire
Exclusion Criteria:
- Withdraw consent to participate in the study
- fail the TASS Safety Screening Questionnaire
- have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump, or a significant history of seizures
- have active suicidal intent
- are pregnant as confirmed by pregnancy test completed as part of pre-study screening
- 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 significant history of seizure except those therapeutically induced by electroconvulsive therapy (ECT), cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis
- 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
- currently (or in the last 4 weeks) take more than lorazepam 2 mg daily (or equivalent) due to seizure risk or any dose of an anticonvulsant due to the potential to limit rTMS efficacy
- non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).
Sites / Locations
- St. Joseph's Healthcare HamiltonRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
rTMS
Arm Description
treatment with repetitive transcranial magnetic stimulation for 30 days
Outcomes
Primary Outcome Measures
Change in Aggressive Incident Scale (AIS)
ranking scale of aggressive incidents
Secondary Outcome Measures
Full Information
NCT ID
NCT02990442
First Posted
November 23, 2016
Last Updated
April 18, 2019
Sponsor
St. Joseph's Healthcare Hamilton
Collaborators
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT02990442
Brief Title
The Effect of Rapid Transcranial Magnetic Stimulation (rTMS) on Aggression in Forensic Patients
Official Title
The Effect of Rapid Transcranial Magnetic Stimulation (rTMS) on Aggression in Forensic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
March 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Joseph's Healthcare Hamilton
Collaborators
University Health Network, Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Forensic patients will undergo 30 rTMS treatments, once per day each business day using a 1Hz frequency at the right dorso-lateral pre frontal cortex, located using modified BEAM F3. Patients will be assessed before and after the study with a battery of assessments and using 2 computer tasks: a ball passing task, and the Point Subtraction Aggression Paradigm (PSAP). The investigators will also monitor and record aggressive incidents that take place on the unit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aggression
Keywords
rTMS, Repetitive Transcranial Magnetic Stimulation, Brain Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
rTMS
Arm Type
Experimental
Arm Description
treatment with repetitive transcranial magnetic stimulation for 30 days
Intervention Type
Device
Intervention Name(s)
rTMS
Intervention Description
repetitive transcranial magnetic stimulation, 1Hz protocol to right dorsolateral pre frontal cortex (R_DLPFC)
Primary Outcome Measure Information:
Title
Change in Aggressive Incident Scale (AIS)
Description
ranking scale of aggressive incidents
Time Frame
30 days
Other Pre-specified Outcome Measures:
Title
Change in Ball sharing task score
Description
computer task
Time Frame
30 days
Title
Change in Point Subtraction Aggression Paradigm (PSAP)
Description
computer task
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
are voluntary and competent to consent to treatment
are a current Forensics inpatient at St. Joseph's West 5th Campus
demonstrate aggressive behavior as confirmed by a psychologist or psychiatrist including verbal and physical aggression
are between the ages of 18 and 65
have had no changes in dose or initiation of any psychotropic medication in the 4 weeks prior to motor threshold
are willing and able to adhere to the treatment schedule
pass the TMS adult Safety-Screening (TASS) Questionnaire
Exclusion Criteria:
Withdraw consent to participate in the study
fail the TASS Safety Screening Questionnaire
have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump, or a significant history of seizures
have active suicidal intent
are pregnant as confirmed by pregnancy test completed as part of pre-study screening
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 significant history of seizure except those therapeutically induced by electroconvulsive therapy (ECT), cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis
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
currently (or in the last 4 weeks) take more than lorazepam 2 mg daily (or equivalent) due to seizure risk or any dose of an anticonvulsant due to the potential to limit rTMS efficacy
non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sheila Verhage-Brown, 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
Head of Forensics
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, MD
Phone
905-522-1155
Ext
36356
Email
sverhage@stjoes.ca
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Rapid Transcranial Magnetic Stimulation (rTMS) on Aggression in Forensic Patients
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