Efficacy of Pain Intervention With Deep Brain Stimulation Neuromodulation

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Central Post Stroke Pain

In brief

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

Key facts

Study ID

NCT06387914

Run by

University of Oxford

People needed

30

Starts

2024-08-07

Expected to finish

2028-12-01

Last updated by the study team

2025-11-19

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• John Radcliffe Hospital — Oxford, Oxfordshire, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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