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临床试验/CTRI/2018/06/014360
CTRI/2018/06/014360尚未招募不适用

Neurobiological correlates and translational implications of neuromodulation in OCD:A high definition transcranial direct current stimulation (HD-tdcs) study

National Institute of Mental Health And Neurosciences NIMHANS Bangalore1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2018年6月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
140
试验地点
1
主要终点
Functional MRI (fMRI)- Resting fMRI and with cognitive activation task(Symptom provocation paradigm followed by Stop-signal task)

研究概览

简要总结

Obsessive-compulsive disorder(OCD) is a common anddebilitating neuropsychiatric disorder. The proposedresearch aims to examine the effect of anodal right pre-supplementary motorarea(pre-SMA) high definition transcranial direct current stimulation(HD-tDCS)on neurocognitive functions, and respective physiological correlates inpatients with OCD who have persistent symptomsdespite being on adequate treatment with medications. Task-relatedphysiological alterations is proposed to be examined through comprehensiveassessment of neurohemodynamic and electrophysiological changes pertaining to thekey neurocognitive functions coupled with the assessment of neurochemicalalterations(glutamate and N-acetyl aspartate) in pre-SMA before and after 10 days ofHD-tDCS sessions (conducted 2 sessions per day) using a randomised sham controlled design. Following the RCT phase those patients who have only <25% improvement will be offered an open label extension phase for addition 10 days. The translational implication is to evaluate novel treatment options for OCD patients who do not respond to conventional treatment options and to understand the mechanistic basis for the brain stimulation method.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Inclusion Criteria: 1.Diagnosis of OCD as per DSM-V criteria (American Psychiatric Association, 2013) 2.Age Range: 18 – 50 Years 3.Either Sex 4.Right-handedness 5.Stable psychotropic medications atleast for 12 weeks and not on cognitive behavioral therapy presently
  • Persistent symptoms despite adequate SSRI treatment (OCD symptom severity according to Yale Brown Obsessive Compulsive Scale score of atleast 16) Healthy controls: Right handed;age,sex and education matched.

排除标准

  • 1.Comorbid psychosis, bipolar disorder, substance dependence (including nicotine dependence) features suggestive of psychiatric emergency (for example: suicidal risk, catatonia, prolonged nutritional deprivation, aggression or excitement) 2.Any contraindication to HD-tDCS procedure-(i) metal in the head,(ii) implanted brain medical devices,(iii)local lesion or injury in the scalp / head 3.Co-morbid neurological/medical disease that can affect the brain structure/function.

结局指标

主要结局

Functional MRI (fMRI)- Resting fMRI and with cognitive activation task(Symptom provocation paradigm followed by Stop-signal task)

时间窗: Baseline and after 10 days of HD tDCS sessions

次要结局

  • Magnetic resonance Spectroscopy – MRS for NAA and glutamate in-vivo signals at pre-SMA(Error Related Negativity (ERN))

研究者

发起方
National Institute of Mental Health And Neurosciences NIMHANS Bangalore
申办方类型
Research institution and hospital

研究点 (1)

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