effect of Anodal Transcranial Direct Current Stimulation (tDCS) in patient with on long standing pain , who are on buprenorphine maintenance treatment

Phase 2

Not yet recruiting

Lead Sponsor: Postgraduate institute of medical education and research chandigarh , india 160012

Recruitment & Eligibility

Inclusion Criteria

1 Age: 18-50 years.

2 Either sex.

3 A diagnosis of OUD as per DSM-5TR.

4 Maintained on a well-optimized dose of Buprenorphine for at least 12 weeks prior to the

intervention period.

5 Persistent pain symptoms of intensity on Numerical Rating Scale (NRS) 1 to 10) for

which further increase in buprenorphine dose is not possible due to poor tolerance

(nausea, headache, sedation) OR patient refuses to increase the dose of buprenorphine

further.

6 No change in medication is planned during one week of the tDCS treatment course

(except for benzodiazepines)

7 Providing written informed consent

Exclusion Criteria

1. The onset of pain symptoms prior to the onset of opioid use disorder

2. Pain due to secondary causes

3. Patients with primary psychotic or primary mood disorders.

4. Patients with a neurological disorder like multiple sclerosis, stroke, epilepsy, or

encephalopathy due to any cause.

5. Patients with any intracranial metallic and electric implants.

6. Patients with comorbid organic brain syndrome and intellectual disability.

7. Patients with OUD associated with underlying organic illness.

8. Patients with comorbid substance use disorder (moderate to severe) except Nicotine

9. Contra-indications for TMS as reflected in the international safety guidelines which

include metal implants in the face/skull, pacemaker, and primary seizure disorder

Primary Outcome Measures

Name	Time	Method
To evaluate what proportion of eligible study participants consent to the study, initiate tDCS sessions, continue at least 3 sessions, and complete all ten sessionsTimepoint: at the end of 3 session of tDCS and 10th session of tDCS

Secondary Outcome Measures

Name	Time	Method
1. To compare the effects of anodal tDCS and sham stimulation for reduction of pain – intensity, duration, and frequency <br/ ><br>2. To compare the effects of anodal tDCS and sham stimulation on motor cortical excitability measures and examine the correlation between change in pain scores and change in motor cortical excitability. <br/ ><br>3. To compare the frequency of adverse events in participants undergoing anodal tDCS and sham stimulation <br/ ><br>Timepoint: Assessment after the last or 10th stimulation session and reassessment after 1 month