Deep brain stimulation for chronic post-stroke pai

Phase 3

Suspended

• Conditions: Chronic post-stroke pain; Signs and Symptoms

• Registration Number: ISRCTN16068776
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-17
• Last Update Posted: 21 June 2021
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Participant is willing and able to give informed consent for participation in the study
2. Patient is willing and able to follow pre and post-operative follow up in Oxford
3. Male or female, aged 18 years or above
4. Participants are diagnosed as having probable chronic post-stroke pain of 2 years’ minimum duration refractory to at least 1 opiate medication, 1 anti-epileptic and 1 anti-depressant, AND mean usual VAS pain score > 7/10 despite input from a multidisciplinary pain team

Exclusion Criteria

1. Contraindication for elective general anaesthesia, for example severe cardiovascular disease
2. Contraindication to MRI
3. Contraindication to neurosurgery, eg. Bleeding disorders, not able to stop anticoagulation safely for perioperative phase (approx. 10 days)
4. Major psychiatric or cognitive disorder that may affect capacity
5. Active skin based infection or colonisation with a multi-drug resistant organism e.g. MRSA
6. Patient requiring regular MRI investigations postoperatively
7. Patient likely to require diathermy, ultrasound or transcranial magnetic stimulation post DBS device insertion.
8. Patient not tolerant of awake surgery
9. Participant not demonstrating adequate response to stimulation in stage 1 surgery
10. Patient unable to cooperate with device recharging
11. Pregnancy or planned pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified