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

Effect of Anodal Transcranial Direct Current Stimulation (tDCS) on Chronic Pain and Motor Cortical Excitability in individuals receiving Buprenorphine Maintenance Treatment – a Pilot, Randomised Controlled Trial - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/01/061029
Enrollment
40
Registered
2024-01-01
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F112- Opioid dependence

Interventions

Intervention1: Anodal tDCS for the treatment of chronic pain in patients receiving buprenorphine maintenance treatment.: anodal tDCS has shown enhance engagement of a descending pain modulatory netwo

Sponsors

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

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1. To compare the effects of anodal tDCS and sham stimulation for reduction of pain – intensity, duration, and frequency 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. 3. To compare the frequency of adverse events in participants undergoing anodal tDCS and sham stimulation Timepoint: Assessment after the last or 10th stimulation session and reassessment after 1 month

Countries

India

Contacts

Public ContactMondeep Dhankar

PGIMER

drshalini.anji@gmail.com9886313489

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026