Efficacy of Pain Intervention With Deep Brain Stimulation Neuromodulation
University of Oxford
30 participants
Aug 7, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria12
- 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
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Interventions
Neurostimulation of the periaqueductal gray matter and sensory thalamus at a level with potential to provide pain relief
Neurostimulation of the periaqueductal gray matter and sensory thalamus S at a low level, not designed to provide pain relief
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06387914