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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02990442
Recruitment Status : Recruiting
First Posted : December 13, 2016
Last Update Posted : April 22, 2019
Sponsor:
Collaborator:
University Health Network, Toronto
Information provided by (Responsible Party):
Gary Chaimowitz, St. Joseph's Healthcare Hamilton

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.

Condition or disease Intervention/treatment Phase
Aggression Device: rTMS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Rapid Transcranial Magnetic Stimulation (rTMS) on Aggression in Forensic Patients
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Arm Intervention/treatment
Experimental: rTMS
treatment with repetitive transcranial magnetic stimulation for 30 days
Device: rTMS
repetitive transcranial magnetic stimulation, 1Hz protocol to right dorsolateral pre frontal cortex (R_DLPFC)




Primary Outcome Measures :
  1. Change in Aggressive Incident Scale (AIS) [ Time Frame: 30 days ]
    ranking scale of aggressive incidents


Other Outcome Measures:
  1. Change in Ball sharing task score [ Time Frame: 30 days ]
    computer task

  2. Change in Point Subtraction Aggression Paradigm (PSAP) [ Time Frame: 30 days ]
    computer task



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02990442


Contacts
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Contact: Sheila Verhage-Brown, MD 905-522-1155 ext 36356 sverhage@stjoes.ca

Locations
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Canada, Ontario
St. Joseph's Healthcare Hamilton Recruiting
Hamilton, Ontario, Canada, L8N3K7
Contact: Sheila Verhage-Brown, MD    905-522-1155 ext 36356    sverhage@stjoes.ca   
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
University Health Network, Toronto
Investigators
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Principal Investigator: Gary Chaimowitz, MD, FRCPC Head of Forensics
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Responsible Party: Gary Chaimowitz, Head of Forensics, St. Joseph's Healthcare Hamilton
ClinicalTrials.gov Identifier: NCT02990442    
Other Study ID Numbers: 1938
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gary Chaimowitz, St. Joseph's Healthcare Hamilton:
rTMS
Repetitive Transcranial Magnetic Stimulation
Brain Stimulation
Additional relevant MeSH terms:
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Aggression
Behavioral Symptoms