AggressionNCT02990442
The Effect of Rapid Transcranial Magnetic Stimulation (rTMS) on Aggression in Forensic Patients
A study testing rTMS in people with Aggression, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Aggression
- What is being tested?
- rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2017to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N3K7
Sheila Verhage-Brown, MD, 905-522-1155 ext. 36356, sverhage@stjoes.ca
About this study
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
- Being tested
- rTMS
- Keywords
- rTMS, Repetitive Transcranial Magnetic Stimulation, Brain Stimulation
- Medical subject headings
- Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
repetitive transcranial magnetic stimulation, 1Hz protocol to right dorsolateral pre frontal cortex (R_DLPFC)
| Study group | Role | What they receive |
|---|---|---|
| rTMS | Experimental | treatment with repetitive transcranial magnetic stimulation for 30 days Receives: Device: rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Aggressive Incident Scale (AIS)
ranking scale of aggressive incidents
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study start1 Nov 2017
- Primary completionMar 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AggressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto
- Responsible party
- Principal investigator, Gary Chaimowitz, St. Joseph's Healthcare Hamilton
- Investigators
- Gary Chaimowitz, MD, FRCPC, Principal investigator, Head of Forensics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02990442
- Sponsor's protocol ID
- 1938
- Status last verified
- Apr 2019
- First submitted
- 23 Nov 2016
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Rapid Transcranial Magnetic Stimulation (rTMS) on Aggression in Forensic Patients
- ClinicalTrials.gov ID
- NCT02990442
- Acronym / sponsor ID
- 1938
- Conditions
- Aggression
- Keywords
- rTMS, Repetitive Transcranial Magnetic Stimulation, Brain Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Collaborators
- University Health Network, Toronto
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 13 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rTMS | Experimental | Device: rTMStreatment with repetitive transcranial magnetic stimulation for 30 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rTMSrepetitive transcranial magnetic stimulation, 1Hz protocol to right dorsolateral pre frontal cortex (R_DLPFC) | Device | rTMS |
Primary outcome
Change in Aggressive Incident Scale (AIS)
Time frame: 30 days
ranking scale of aggressive incidents
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Aggression
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingPhase 3
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
Metastatic Dedifferentiated Liposarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma
RecruitingPhase 2
Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma
High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements, Recurrent Diffuse Large B-Cell Lymphoma
Recruiting
Momentary Coping Prompts and Hair Steroids in College Students
Emotional Regulation, Alcohol Drinking in College
Active, not recruitingPhase 1/2
First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
DLBCL, High-grade B-cell Lymphoma (HGBCL)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Chaimowitz, MD, FRCPC principal investigator
Head of Forensics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS in people with Aggression, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sheila Verhage-Brown, MD (905-522-1155 ext. 36356, sverhage@stjoes.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Aggressive Incident Scale (AIS) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2019.