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Efficacy of Pain Intervention With Deep Brain Stimulation Neuromodulation

NCT06387914 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-11-19

No results posted yet for this study

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

Conditions

  • Central Post Stroke Pain

Interventions

DEVICE

Stimulation ON

Neurostimulation of the periaqueductal gray matter and sensory thalamus at a level with potential to provide pain relief

DEVICE

Stimulation Pseudo-ON

Neurostimulation of the periaqueductal gray matter and sensory thalamus S at a low level, not designed to provide pain relief

Sponsors & Collaborators

  • Jon MoultonTrust

    collaborator UNKNOWN

  • Placito Bequest

    collaborator UNKNOWN

  • Bioinduction

    collaborator INDUSTRY

  • University of Oxford

    lead OTHER

Principal Investigators

  • Alexander Green, MD, DPhil · Nuffield Department of Surgical Sciences

  • Timothy Denison, PhD · Institute of Biomedical Engineering, Old Road Campus Research Building, Oxford OX3 7DQ

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-07
Primary Completion
2028-03-31
Completion
2028-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06387914 on ClinicalTrials.gov