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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02990442
Enrollment
10
Registered
2016-12-13
Start date
2017-11-01
Completion date
2020-03-31
Last updated
2019-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aggression

Keywords

rTMS, Repetitive Transcranial Magnetic Stimulation, Brain Stimulation

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.

Interventions

DEVICErTMS

repetitive transcranial magnetic stimulation, 1Hz protocol to right dorsolateral pre frontal cortex (R\_DLPFC)

Sponsors

University Health Network, Toronto
CollaboratorOTHER
St. Joseph's Healthcare Hamilton
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Change in Aggressive Incident Scale (AIS)30 daysranking scale of aggressive incidents

Other

MeasureTime frameDescription
Change in Point Subtraction Aggression Paradigm (PSAP)30 dayscomputer task
Change in Ball sharing task score30 dayscomputer task

Countries

Canada

Contacts

Primary ContactSheila Verhage-Brown, MD
sverhage@stjoes.ca905-522-1155

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026