NCT02990442

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 13, 2016

Completed
11 months until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

April 22, 2019

Status Verified

April 1, 2019

Enrollment Period

2.3 years

First QC Date

November 23, 2016

Last Update Submit

April 18, 2019

Conditions

Aggression

Keywords

rTMSRepetitive Transcranial Magnetic StimulationBrain Stimulation

Outcome Measures

Primary Outcomes (1)

  • Change in Aggressive Incident Scale (AIS)

    ranking scale of aggressive incidents

    30 days

Other Outcomes (2)

  • Change in Ball sharing task score

    30 days

  • Change in Point Subtraction Aggression Paradigm (PSAP)

    30 days

Study Arms (1)

rTMS

EXPERIMENTAL

treatment with repetitive transcranial magnetic stimulation for 30 days

Device: rTMS

Interventions

rTMSDEVICE

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

rTMS

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • are voluntary and competent to consent to treatment
  • are a current Forensics inpatient at St. Joseph's West 5th Campus
  • demonstrate aggressive behavior as confirmed by a psychologist or psychiatrist including verbal and physical aggression
  • are between the ages of 18 and 65
  • have had no changes in dose or initiation of any psychotropic medication in the 4 weeks prior to motor threshold
  • are willing and able to adhere to the treatment schedule
  • pass the TMS adult Safety-Screening (TASS) Questionnaire

You may not qualify if:

  • Withdraw consent to participate in the study
  • fail the TASS Safety Screening Questionnaire
  • have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump, or a significant history of seizures
  • have active suicidal intent
  • are pregnant as confirmed by pregnancy test completed as part of pre-study screening
  • 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
  • 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
  • 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
  • non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N3K7, Canada

RECRUITING

MeSH Terms

Conditions

Aggression

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial Behavior

Study Officials

  • Gary Chaimowitz, MD, FRCPC

    Head of Forensics

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheila Verhage-Brown, MD

CONTACT

905-522-1155sverhage@stjoes.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Forensics

Study Record Dates

First Submitted

November 23, 2016

First Posted

December 13, 2016

Study Start

November 1, 2017

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

April 22, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)