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Tests treatment safety and results for Central Post Stroke Pain
Official title Efficacy of Pain Intervention With Deep Brain Stimulation Neuromodulation
ClinicalTrials.gov ID: NCT06387914
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join 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
You likely can't join 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...
- Active skin-based infection or colonisation with a multi-drug resistant organism e.g. methicillin-resistant Staphylococcus aureus (MRSA)
See the full eligibility criteria
- 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.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Oxford, Oxfordshire, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oxford, Oxfordshire, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.