Chronic post-stroke pain Signs and Symptoms
Conditions
Interventions
The design is a pragmatic assessor-blinded, randomised controlled trial. The design seeks to exploit the feature of deep brain stimulation technique that the surgery to implant the DBS device is not t
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the study 2. Patient is willing and able to follow pre and post-operative follow up in Oxford 3. Male or female, aged 18 years or above 4. Participants are diagnosed as having probable chronic post-stroke pain of 2 years’ minimum duration refractory to at least 1 opiate medication, 1 anti-epileptic and 1 anti-depressant, AND mean usual VAS pain score > 7/10 despite input from a multidisciplinary pain team
Exclusion criteria
Exclusion criteria: 1. Contraindication for elective general anaesthesia, for example severe cardiovascular disease 2. Contraindication to MRI 3. Contraindication to neurosurgery, eg. Bleeding disorders, not able to stop anticoagulation safely for perioperative phase (approx. 10 days) 4. Major psychiatric or cognitive disorder that may affect capacity 5. Active skin based infection or colonisation with a multi-drug resistant organism e.g. MRSA 6. Patient requiring regular MRI investigations postoperatively 7. Patient likely to require diathermy, ultrasound or transcranial magnetic stimulation post DBS device insertion. 8. Patient not tolerant of awake surgery 9. Participant not demonstrating adequate response to stimulation in stage 1 surgery 10. Patient unable to cooperate with device recharging 11. Pregnancy or planned pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain experience of participants assessed by the following tools by a member of the research team pre operatively and post operatively, blinded as to whether stimulation is on or off in the first 6 months post-operatively, then unblinded after 6 months: 1. Pain severity assessed using the Visual analogue scale (VAS), McGill Pain Questionnaire (MPQ), brief pain inventory (BPI)) 2. Affective component of pain assessed using the Montgomery Asberg Depression Rating Scale (MADRS), McGill Affective Pain index 3. Quality of life assessed using EuroQol-5D (EQ-5D), Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36), Hospital Anxiety and Depression Scale (HADS) and the Functional Limitation Profile (FLP) 4. Neuropsychological test battery (Wisconsin Card Sorting Test, Weschler Memory Scale III, Intra-/Extra-Dimensional Set-Shifting, Spatial Span, Spatial Working Memory, Verbal Fluency, Recall Test (from the adult memory and information processing battery) and Raven’s Standard Progressive Matrices) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pre-operative neuroimaging and pain assessments to develop algorithms which help predict response to test stimulation and thus improve patient selection. Specific measures are resting-state functional connectivity, task-related functional network connectivity and diffusion-weighted tensor imaging of connectivity of targeted regions i.e. the sensory thalamus or periaqueductal grey. 2. Economic impact of the surgical intervention, assessed using patient-level resource use data including health and social care costs relating to the intervention (e.g. surgical costs, drug costs, hospital stay, GP costs, referrals etc). In line with recent recommendations from the National Institute for Health and Clinical Excellence (NICE) the economic evaluation will also include the generic quality of life instrument, the EuroQol EQ-5D-5L (EuroQol 1990). | — |
Countries
United Kingdom
Outcome results
None listed