Clinical trial NCT02990442: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Aggression
Keywords: rTMS
Repetitive Transcranial Magnetic Stimulation
Brain Stimulation
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
Collaborators: name: University Health Network, Toronto
First posted: 2016-12-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Change in Aggressive Incident Scale (AIS)
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
measure: Change in Ball sharing task score
timeFrame: 30 days
measure: Change in Point Subtraction Aggression Paradigm (PSAP)
timeFrame: 30 days
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: Head of Forensics
name: Gary Chaimowitz, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: