Examining the efficacy of brain stimulation for a neuropsychiatric disorder called OCD

Not yet recruiting

Conditions: Healthy human volunteers without psychiatric illness are recruited for the trial assessments (clinical scales, EEG, MRI, cognition) at the baseline. However, they will not receive any intervention.
Patients with Obsessive Compulsive Disorder

Registration Number: CTRI/2018/06/014360

Lead Sponsor: National Institute of Mental Health And Neurosciences NIMHANS Bangalore

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 140

Inclusion Criteria

Inclusion Criteria: 1.Diagnosis of OCD as per DSM-V criteria (American Psychiatric Association, 2013) 2.Age Range: 18 â€“ 50 Years 3.Either Sex 4.Right-handedness 5.Stable psychotropic medications atleast for 12 weeks and not on cognitive behavioral therapy presently 6.
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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional MRI (fMRI)- Resting fMRI and with cognitive activation task(Symptom provocation paradigm followed by Stop-signal task)	Baseline and after 10 days of HD tDCS sessions

Secondary Outcome Measures

Name	Time	Method
Magnetic resonance Spectroscopy â€“ MRS for NAA and glutamate in-vivo signals at pre-SMA	Error Related Negativity (ERN)

Trial Locations

Locations (1): National Institute of Mental Health And Neurosciences , Bangalore
🇮🇳
Bangalore, KARNATAKA, India
National Institute of Mental Health And Neurosciences , Bangalore
🇮🇳Bangalore, KARNATAKA, India
Dr Janardhanan C Narayanaswamy
Principal investigator
9481475125
jairamnimhans@gmail.com