Effect of Repetitive Transcranial Magnetic Stimulation on Symptoms of Attention Deficit Hyperactivity Disorder and Cognitive Function In Cocaine Addicts
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Wender Utah Rating Scale (WURS) - Diagnostic Criteries ADHD (DSM IV)
研究概览
简要总结
Even in the absence of a preliminary diagnosis of Attention Deficit Hyperactivity Disorder, symptoms of attention deficit, hyperactivity and cognitive impairment are common in cocaine addicts.
Several factors indicate that repetitive transcranial magnetic stimulation might be a strategy to aid in the treatment of symptoms of attention deficit hyperactivity disorder and cognitive function in cocaine addicts.
However, up to current days there have been no studies evaluating the effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on neurocognitive performance of individuals suffering from the ADHD.
详细描述
Transcranial Magnetic Stimulation is a noninvasive technique that can influence specific areas of the brain and has very few side effects.
The treatment with transcranial magnetic stimulation requires attendance to hospital daily sessions for 4 consecutive weeks. Each session lasts up to 30 minutes.
Side effects include scalp discomfort and mild headache. No anesthesia is required.
Stimulation aims the dorsolateral prefrontal cortex, a region previously studied to treat depression symptoms with positive results.
The present technique has never been employed in previous studies, but risks are insignificant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Cocaine Dependence Syndrome (alone or in combination with alcohol and/or nicotine dependence with symptoms of ADHD, according to the criteria of the DSM-IV-R (APA, 2000), as well as through a structured clinical interview (SCID-1/P v 2.0)
- •Minimum age of 18
- •Maximum age of 40
- •20 days or less abstinence.
- •any psychopharmacological treatment other than clonazepam (4 mg/day)
排除标准
- •Metallic Cerebral Implant
- •Pacemakers
- •History of Severe Brain trauma or injury
- •Organic Brain Disease
- •Previous neurosurgery
- •History of seizures
- •Severe Somatic Disease
- •History of other actual or past psychiatric diagnostics
- •Clinically significant changes in laboratory test
- •Any psychiatric or neurological disorder other than Cocaine Dependence with symptoms of ADHD
- •Psychotic depression
- •Suicidal propensities
结局指标
主要结局
Wender Utah Rating Scale (WURS) - Diagnostic Criteries ADHD (DSM IV)
时间窗: 4 weeks
Scales to assess attention deficit hyperactivity disorder symptoms will be applied at pre-treatment (T0) and post treatment - week 4 (T1). Reduction on the scores of WURS and synptoms of ADHD diagnostic (as on the scores of Barrat Impulsiviness Scale - BIS 11 and Minnesota Cocaine Craving Scale - MCCS; and improves Hamilton Depressive Rating Scale - HDRS 17 and Hamilton Anxiety Rating Scale - HARS 14).
次要结局
- Battery of Neuropsychological Tests(4 weeks)