The Effect of Rapid Transcranial Magnetic Stimulation (rTMS) on Aggression in Forensic Patients

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.

Study Overview

• Status: Unknown
• Conditions: Aggression
• Intervention / Treatment: Device: rTMS

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N3K7
      • Recruiting
      • St. Joseph's Healthcare Hamilton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. are voluntary and competent to consent to treatment
2. are a current Forensics inpatient at St. Joseph's West 5th Campus
3. demonstrate aggressive behavior as confirmed by a psychologist or psychiatrist including verbal and physical aggression
4. are between the ages of 18 and 65
5. have had no changes in dose or initiation of any psychotropic medication in the 4 weeks prior to motor threshold
6. are willing and able to adhere to the treatment schedule
7. pass the TMS adult Safety-Screening (TASS) Questionnaire

Exclusion Criteria:

1. Withdraw consent to participate in the study
2. fail the TASS Safety Screening Questionnaire
3. have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump, or a significant history of seizures
4. have active suicidal intent
5. are pregnant as confirmed by pregnancy test completed as part of pre-study screening
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 significant history of seizure except those therapeutically induced by electroconvulsive therapy (ECT), cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis
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. 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
9. non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: rTMS; treatment with repetitive transcranial magnetic stimulation for 30 days	Device: rTMS; repetitive transcranial magnetic stimulation, 1Hz protocol to right dorsolateral pre frontal cortex (R_DLPFC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Aggressive Incident Scale (AIS)	ranking scale of aggressive incidents	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Ball sharing task score	computer task	30 days
Change in Point Subtraction Aggression Paradigm (PSAP)	computer task	30 days

Collaborators and Investigators

• Sponsor: St. Joseph's Healthcare Hamilton
• Collaborators: University Health Network, Toronto
• Investigators: Principal Investigator: Gary Chaimowitz, MD, FRCPC, Head of Forensics

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2017
• Primary Completion (ANTICIPATED): March 1, 2020
• Study Completion (ANTICIPATED): March 1, 2020

Study Registration Dates

• First Submitted: November 23, 2016
• First Submitted That Met QC Criteria: December 8, 2016
• First Posted (ESTIMATE): December 13, 2016

Study Record Updates

• Last Update Posted (ACTUAL): April 22, 2019
• Last Update Submitted That Met QC Criteria: April 18, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: rTMS; Brain Stimulation; Repetitive Transcranial Magnetic Stimulation
• Additional Relevant MeSH Terms: Behavioral Symptoms; Aggression
• Other Study ID Numbers: 1938

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No