Actively Recruiting
Efficacy of Pain Intervention With Deep Brain Stimulation Neuromodulation
Led by University of Oxford · Updated on 2025-11-19
30
Participants Needed
1
Research Sites
225 weeks
Total Duration
On this page
Sponsors
U
University of Oxford
Lead Sponsor
J
Jon MoultonTrust
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Efficacy of Pain Intervention With Deep Brain Stimulation Neuromodulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 with central post stroke pain lasting at least 2 years that has not improved with best medical or non-medical treatment
- Average usual pain score greater than 6 out of 10 despite multidisciplinary pain team care
You will not qualify if you...
- Contraindication for elective general anaesthesia, including severe cardiovascular disease or electrolyte imbalances
- Previous DBS device implanted and still in place
- Contraindication to MRI
- Contraindication to neurosurgery, including bleeding disorders or inability to safely stop anticoagulation around surgery
- Untreated major psychiatric or cognitive disorder affecting mental capacity or trial participation
- Active skin infection or colonization with multi-drug resistant organisms such as MRSA
- Need for regular MRI scans after surgery
- Likely need for diathermy, ultrasound, or transcranial magnetic stimulation after DBS insertion
- Not tolerant of awake surgery
- Unable to cooperate with device recharging
- Pregnancy or planned pregnancy
- Inability to comply with the study protocol according to the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
John Radcliffe Hospital
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Actively Recruiting
Research Team
A
Alexander Green, MD, DPhil
CONTACT
M
Martin Gillies, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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