Deep brain stimulation for severe central post-stroke pain
Efficacy of Pain Intervention With Deep Brain Stimulation Neuromodulation
NA · University of Oxford · NCT06387914
This trial will try deep brain stimulation to see if it lowers severe, long-lasting central post-stroke pain in adults who haven't improved with other treatments.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | University of Oxford (other) |
| Locations | 1 site (Oxford, Oxfordshire) |
| Trial ID | NCT06387914 on ClinicalTrials.gov |
What this trial studies
The EPIONE trial is a double-blind, randomized crossover trial testing DBS of the sensory thalamus in adults with central post-stroke pain refractory to best medical and non-medical therapies. After baseline screening and MRI, participants undergo neurosurgical implantation of a DBS device and are randomized to different stimulation parameter phases, including active ON and Pseudo-ON conditions while the device remains implanted. Participants cross over between stimulation settings, attend at least five in-clinic visits with remote assessments over a 10-month period, and then enter a 6-month optimisation phase where stimulation is individualized using features like circadian and motion sensing. Pain, mood, and safety outcomes are measured using standardized questionnaires and clinical assessments.
Who should consider this trial
Good fit: Adults aged 21 or older with at least two years of central post-stroke pain, average pain >6/10 despite multidisciplinary care, who can undergo MRI, neurosurgery, and follow-up in Oxford are eligible.
Not a fit: Patients with contraindications to MRI, general anaesthesia, neurosurgery, ongoing anticoagulation that cannot be stopped, or an existing implanted DBS device are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, DBS could provide substantial and sustained pain relief for people with severe, treatment-refractory central post-stroke pain.
How similar studies have performed: Open-label case series and a pooled meta-analysis have reported moderate benefits of DBS for chronic pain including CPSP, but randomized, blinded evidence is limited and heterogeneous.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria A patient will be eligible for inclusion in this trial if all of the following criteria apply: * Willing and able to give informed consent for participation in the trial. * Willing and able to follow pre and post-operative procedures in Oxford. * Aged 21 years or above. * Diagnosed as having central post stroke pain of 2 years' minimum duration refractory to best medical/non-medical treatment * Mean usual VAS (or NRS) pain score \> 6/10 despite input from a multidisciplinary pain team. Exclusion criteria A patient will not be eligible for the trial if any of the following apply: * Contraindication for elective general anaesthesia, for example but not limited to severe cardiovascular disease, hyponatraemia, hyperkalaemia, etc. * Previous implantation of a DBS device with device still in situ. * Contraindication to MRI * Contraindication to neurosurgery, e.g. Bleeding disorders, not able to stop anticoagulation safely for perioperative phase (approx. 10 days, 5 days pre-operatively, 5 days postoperatively) Major psychiatric or cognitive disorder that may affect mental capacity that is untreated or may otherwise affect the participant's ability to engage in the trial * Active skin-based infection or colonisation with a multi-drug resistant organism e.g. methicillin-resistant Staphylococcus aureus (MRSA) * Requires regular MRI investigations post-operatively * Likely to require diathermy, ultrasound or transcranial magnetic stimulation post DBS device insertion * Not tolerant of awake surgery * Unable to cooperate with device recharging * Pregnancy or planned pregnancy * In the investigator's opinion unable to comply with the protocol
Where this trial is running
Oxford, Oxfordshire
- John Radcliffe Hospital — Oxford, Oxfordshire, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Alexander Green, MD, DPhil — Nuffield Department of Surgical Sciences
- Study coordinator: Alexander Green, MD, DPhil
- Email: alex.green@nds.ox.ac.uk
- Phone: +441865234762
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Central Post Stroke Pain, Deep Brain Stimulation, Neuropathic pain, Randomised Controlled Trial, Sensory thalamus, Periaqueductal Gray