Actively Recruiting

Phase Not Applicable
Age: 21Years +
All Genders
NCT06387914

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

Age: 21Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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