Recruiting

rTMS

Sponsor:

St. Joseph's Healthcare Hamilton

Code:

NCT02990442

Conditions

Aggression

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

rTMS

Study Details

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 ID

NCT02990442

Start date

Nov 1, 2017

Status verified date

Apr, 2019

Completion date

Mar, 2020

Anticipated

Primary completion date

Mar, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: rTMS

treatment with repetitive transcranial magnetic stimulation for 30 days

Interventions

rTMS

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

Primary outcome measure

  • Change in Aggressive Incident Scale (AIS) [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Sheila Verhage-Brown, MD

905-522-1155sverhage@stjoes.ca

Locations

St. Joseph's Healthcare Hamilton

Recruiting

Hamilton, Ontario, Canada, L8N3K7

Contacts

Sheila Verhage-Brown, MD

905-522-1155sverhage@stjoes.ca

More Information

Sponsor

St. Joseph's Healthcare Hamilton

Last update posted

Apr 22, 2019

Last verified

Apr, 2019

Keywords

  • rTMS
  • Repetitive Transcranial Magnetic Stimulation
  • Brain Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Joseph's Healthcare Hamilton on 2019-04-22.