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

NCT ID: NCT02990442

Last Updated: 2019-04-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2020-03-31

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.

Conditions

Aggression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

rTMS

treatment with repetitive transcranial magnetic stimulation for 30 days

Group Type: EXPERIMENTAL

rTMS

Intervention Type: DEVICE

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

Interventions

rTMS

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

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: collaborator

St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role: lead

Responsible Party

Gary Chaimowitz

Head of Forensics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gary Chaimowitz, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Head of Forensics

Locations

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Sheila Verhage-Brown, MD

Role: CONTACT

sverhage@stjoes.ca

905-522-1155 ext. 36356

Facility Contacts

Sheila Verhage-Brown, MD

Role: primary

sverhage@stjoes.ca

905-522-1155 ext. 36356

Other Identifiers

1938

Identifier Type: -

Identifier Source: org_study_id