Investigating the Impact of Intermittent Theta Burst Stimulation (iTBS) on Neurocognition. A Comprehensive Examination of Cognitive Functions Post Treatment Efficacy in Heroin Dependent Individuals. A Single Blind Placebo Controlled Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of Intermittent Theta Burst Stimulation (iTBS) in neurocognitive functions, by using a battery of standardized neuropsychological tests, including Raven’s Standard Progressive Matrices, HVLT Learning Test, the WCST-64, the Iowa Gambling Task, the Stroop Test, the Digit Symbol Substitution Test, and the Stop Signal Task.
研究概览
简要总结
This study aims to examine the impact of Intermittent Theta Burst Stimulation (iTBS) on neurocognitive function in individuals with heroin dependence.The study intends to offer a deeper understanding of how iTBS impacts the neurocognitive aspects of people with heroin dependence through rigorous assessment and analysis. Specifically, post-treatment efficacy, cognitive function and craving It is a clinical trial that follows a single-blind, randomized, placebo-controlled approach. Participants will be categorized into three groups:
The first group will be assigned to receive active iTBS treatment. The second group will be given sham iTBS as a placebo control. The third group will be comprised of healthy individuals. (This group will not recive any intervention and are only the control group)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age range: 18 to 60 years.
- •Any sexual orientation.
- •Giving informed consent in writing.
- •A DSM 5 (ICD-11) diagnosis of opioid (Heroin) use disorder.
- •Tobacco dependence will be included.
- •Basic education level of 8th and above.
- •Individuals suffering from physical comorbidities like diabetes, HIV, HCV will be included.
- •All participants will be right-handed as per Edinburgh Handedness inventory (1971)-Right Handedness.
排除标准
- •Individuals who suffer from co-occurring substance use disorders, excluding heroine.
- •Individuals who have any kind of electrical or metallic intracranial implants.
- •Women who are nursing or pregnant.
- •Individuals with intellectual disability.
- •Individuals suffering from any kind of neurological condition, such as multiple sclerosis, stroke, epilepsy, or encephalopathy.
- •Individuals suffering from primary mood disorders or primary psychosis.
结局指标
主要结局
To evaluate the efficacy of Intermittent Theta Burst Stimulation (iTBS) in neurocognitive functions, by using a battery of standardized neuropsychological tests, including Raven’s Standard Progressive Matrices, HVLT Learning Test, the WCST-64, the Iowa Gambling Task, the Stroop Test, the Digit Symbol Substitution Test, and the Stop Signal Task.
时间窗: Baseline, T3 days, T90 days
次要结局
- To test saftey and tolerability of the iTBS treatment.(To test iTBS treatment Efficacy in the reduction of craving.)
研究者
Dhruv Singh Bangar
Postgraduate Institute of Medical Education and Reserach