Deep brain stimulation for severe central post-stroke pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.