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临床试验/CTRI/2024/03/063896
CTRI/2024/03/063896尚未招募1 期

Efficacy of adjunctive alpha TRANSCRANIAL ALTERNATING CURRENT STIMULATION in Obsessive Compulsive Disorder as measured by functional MAGNETIC RESONANCE IMAGING:A sham controlled study.

Central Institute of Psychiatry1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年3月19日最近更新:

试验速览

阶段
1 期
状态
尚未招募
入组人数
40
试验地点
1
主要终点
application of 20 sessions of alpha tACS.

研究概览

简要总结

OCD is a major mental health condition accompanied by severe distress, high levels of disability, and disruption of the person’s social and occupational functioning.In the functional neuroanatomy of OCD, a critical role has been assigned to the orbitofrontal cortex (OFC), a brain region crucially involved in reward-guided learning and decision making.Transcranial alternating current stimulation (tACS) is a form of non-invasive brain stimulation which modulates neural oscillations in humans by application of weak electric current to the scalp.Current medication and behaviour therapies in OCD, although effective in most patients, fail to provide adequate benefit in many patients most severely affected.Although studies done on TMS and tDCS have shown promising results, the opinion about their efficacy on OCD as a treatment modality remains equivocal.The past studies using tACS on OCD population to be effective but it includes only case series, case reports and studies on non-clinical population.To the best of our knowledge, no study has been done targeting the OFC using tACS in OCD population, hence this study intends to assess the efficacy of tACS on OFC in OCD population.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor 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

  • Diagnosis of obsessive compulsive disorder according to ICD 11 DCR(WHO,2022).
  • Age between 18- 60 years of either sex.
  • Patients with YBOCS score of 16 or above.
  • Patients should be on stable dose of antiobsessive and antipsychotic medications.
  • Right-handed.
  • Patients who have not received Cognitive Behavioural Therapy in the past 2 weeks of the study.
  • Patients with mild to moderate depression associated with obsessive compulsive disorder.

排除标准

  • OCD with severe depression as measured by HDRS score more than
  • Presence of co-morbid neurological or other psychiatric disorder(s).
  • Patient with co morbid substance dependence, except nicotine and caffeine.
  • Having any metallic implants/parts in body.
  • Patients not giving written informed consent.

结局指标

主要结局

application of 20 sessions of alpha tACS.

时间窗: Primary outcome variable will be Reduction in YBOCS SCORE from baseline at the end of 2 weeks after | application of 20 sessions of alpha tACS.

Reduction in YBOCS SCORE from baseline after

时间窗: Primary outcome variable will be Reduction in YBOCS SCORE from baseline at the end of 2 weeks after | application of 20 sessions of alpha tACS.

次要结局

  • Changes in BOLD activation in Orbitofrontal Cortex after application(of 20 sessions of alpha tACS.)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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