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

Aggression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02990442
• Other study ID #: 1938
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: March 2020

Study information

• Verified date: April 2019
• Source: St. Joseph's Healthcare Hamilton
• Contact: Sheila Verhage-Brown, MD
• Phone: 905-522-1155
• Email: sverhage[@]stjoes.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Aggression

Intervention

Device:
• rTMS
repetitive transcranial magnetic stimulation, 1Hz protocol to right dorsolateral pre frontal cortex (R_DLPFC)

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton	University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Ball sharing task score	computer task	30 days
Other	Change in Point Subtraction Aggression Paradigm (PSAP)	computer task	30 days
Primary	Change in Aggressive Incident Scale (AIS)	ranking scale of aggressive incidents	30 days