Deep Transcranial Magnetic Stimulation as add-on treatment for Children and Adolescents with Obsessive Compulsive Disorder: An open label study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
The current study is to be carried out in the National Institute of Mental Health And Neurosciences, Bengaluru. Children and Adolescents with primary diagnosis of OCD and previous failed trial of SSRI/CBT will be recruited for trial of dTMS as an add-on therapy in addition to treatment as usual. It is a single-arm open label trial. Each individual will be screened for inclusion/exclusion criteria, Screening standard questionnaire for TMS safety and comorbidities using DIAMOND-KID. Informed consent from parents and assent from children/adolescents will be taken. 20 sessions of high-frequency deep TMS will be given with one session each day. TMSens_Q, a tool to track adverse effects of TMS will be used to monitor participants and participation will be discontinued in case of any serious adverse effect. OCD severity will be measured using CY-BOCS; Anxiety/depression using RCADS and overall clinical condition using CGI and CGAS scales. Clinical scales will be applied at T1 (Pre-intervention), T2(post-intervention), T3(1 month post-intervention) and T4(3months post-intervention). Linear mixed model will be used to assess the effect of the intervention accounting for within-subject correlations with time as a fixed factor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 7.00 Year(s) 至 17.00 Year(s)(—)
- 性别
- All
入选标准
- •Individuals with primary diagnosis of OCD as per DSM-5, age 7-17 of any gender, with a previous trail of at least 12 weeks of an SSRI or CBT.
排除标准
- •History of seizure, head injury, other neurological conditions that may reduce seizure threshold, raised intra-cranial tension, metal implants in head or face, Severe metal illness such as Schizophrenia or Bipolar Disorder, Acute suicidal Risk, Moderate/Severe/Profound Intellectual Disability.
研究者
Dr Priyadeep Zamindar
NIMHANS, Bengaluru
