Efficacy of Pain Intervention With Deep Brain Stimulation Neuromodulation
ConditionCentral Post Stroke Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorUniversity of Oxford
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Stimulation ON
- Stimulation Pseudo-ON
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Oxford
Lead sponsor
Jon MoultonTrust
Collaborator
Placito Bequest
Collaborator
Bioinduction
Collaborator
Source ClinicalTrials.gov