NCT02990442Unknown不适用
The Effect of Rapid Transcranial Magnetic Stimulation (rTMS) on Aggression in Forensic Patients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in Aggressive Incident Scale (AIS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
rTMS
Experimental
treatment with repetitive transcranial magnetic stimulation for 30 days
干预措施: rTMS (Device)
结局指标
主要结局
Change in Aggressive Incident Scale (AIS)
时间窗: 30 days
ranking scale of aggressive incidents
次要结局
未报告次要终点
研究者
Gary Chaimowitz
Head of Forensics
St. Joseph's Healthcare Hamilton
研究点 (2)
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