The Effect of Rapid Transcranial Magnetic Stimulation (rT... | NCT02990442

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

NCT02990442

Sponsor

St. Joseph's Healthcare Hamilton

Status

Unknown status

Last Update Posted

Apr 22, 2019Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Aggression

Interventions

rTMS

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2017Actual

Primary Completion Date

Mar 2020Estimated

Completion Date

Mar 2020Estimated

First Submitted Date

Nov 23, 2016

First Submission Date that Met QC Criteria

Dec 8, 2016

First Posted Date

Dec 13, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2019

Last Update Posted Date

Apr 22, 2019Actual

Name	Class
University Health Network, Toronto	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
rTMS	Experimental	treatment with repetitive transcranial magnetic stimulation for 30 days	Device: rTMS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rTMS	Device	repetitive transcranial magnetic stimulation, 1Hz protocol to right dorsolateral pre frontal cortex (R_DLPFC)	rTMS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Aggressive Incident Scale (AIS)	ranking scale of aggressive incidents	30 days

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
Change in Ball sharing task score	computer task	30 days
Change in Point Subtraction Aggression Paradigm (PSAP)	computer task	30 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D000096762	Aberrant Motor Behavior in Dementia
D001526	Behavioral Symptoms
D001519	Behavior
D012919	Social Behavior