NCT06387914 Efficacy of Pain Intervention With Deep Brain Stimulation Neuromodulation
| NCT ID | NCT06387914 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Oxford |
| Condition | Central Post Stroke Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-08-07 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2024-08-07 with a primary completion date of 2028-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn if deep brain stimulation (DBS) works to treat severe pain following a stroke in adults. It will also learn about the safety of deep brain stimulation. The main questions it aims to answer are: * Does DBS lower the pain score in these participants. * What medical problems do participants have when having DBS? Researchers will compare different settings, to see if DBS works to treat severe post stroke pain. Participants will: * Undergo baseline screening procedures and have an MRI scan. * Have neurosurgery to put the DBS system in * Have follow up for 10 months * Visit the clinic at least 5 times in the study for check-ups and tests * Fill in questionnaires about pain and mood and have check ups remotely
Eligibility 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
Contact & Investigator
Alexander Green, MD, DPhil
PRINCIPAL INVESTIGATOR
Nuffield Department of Surgical Sciences
Frequently Asked Questions
Who can join the NCT06387914 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Central Post Stroke Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06387914 currently recruiting?
Yes, NCT06387914 is actively recruiting participants. Contact the research team at alex.green@nds.ox.ac.uk for enrollment information.
Where is the NCT06387914 trial being conducted?
This trial is being conducted at Oxford, United Kingdom.
Who is sponsoring the NCT06387914 clinical trial?
NCT06387914 is sponsored by University of Oxford. The principal investigator is Alexander Green, MD, DPhil at Nuffield Department of Surgical Sciences. The trial plans to enroll 30 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.