Cingulotomy for Refractory Neuropathic Pain Following Spinal Cord Injury (CRNP-SCI)

Surgery
Pain
Online since 11 November 2022, updated 466 days ago

About this trial

Neuropathic pain is very common following a spinal cord injury, estimated to affect 43% of patients after 6 months. A proportion of these patients do not respond to treatment and there remains an unme...

Included participants

Gender
All
Age
18 - 70 years
Injury level
Level not specified
  • Severity (AIS)?
  • Time since injury
    ≥ 12 months
    Healthy volunteers
    No
    Level not specified

    What’s involved

    Type

    Surgery

    Details

    Neuropathic pain is very common following spinal cord injury, with significant long-term impact on an individual's quality of life, functional ability and mental health, as well as increased utilisation of health care resources. People living with the effects of spinal cord injury frequently suffer chronic neuropathic pain. A proportion of these do not respond to treatment and there remains an unmet need to treat people with refractory spinal injury related neuropathic pain. While spasms can be treated by baclofen pumps and neuropathic pain sometimes treated by spinal cord stimulation, many patients remain refractory to those surgical treatments. The research aims to establish the efficacy of bilateral anterior cingulotomy to treat chronic pain in people with spinal cord injury. Stereotactic bilateral anterior cingulotomy is a brain operation with demonstrated efficacy in the treatment of intractable pain from a variety of causes, including a few cases of spinal cord injury related neuropathic pain. This may therefore be a therapeutic option for patients refractory to other treatments. Significant recent advances in surgical and imaging techniques have vastly improved the outcomes and safety profile of stereotactic lesioning for multiple indications, most commonly movement disorders but also other conditions including pain. However, only scanty epidemiological data on the effect of this procedure in people with chronic pain are available in the scientific literature so far and it is unclear the number of patients who may benefit from such a treatment. Few case reports have been published reporting a good outcome of bilateral cingulotomy on pain in patients with SCI [8]. Therefore, there is a hope that this procedure may offer significant relief and thus improved quality of life for a proportion of patients with SCI who have exhausted other treatment options. The results of this open label study will provide important information on whether bilateral anterior cingulotomy is an effective treatment in improving pain refractory to other routinely offered treatments in patients with spinal cord injury. This will give scientific evidence for offering this procedure to these patients and alleviate their symptoms and improve their quality of life. If efficacy is established, it may become an established viable option in routine clinical practice. The investigators aim to recruit 12 patients over a period of 24 months with 12 months' follow-up and to analyse and publish their results in the following 12 months. The investigators will ensure that findings will promptly reach the widest audience of potential beneficiaries (academic, clinical, patients and public audiences) to have a practical impact on clinical management of patients with SCI. The investigators aim to demonstrate whether this procedure can provide sustained symptomatic relief while carefully monitoring for the development of adverse effects. They propose a pilot open label study of 12 patients with refractory neuropathic pain associated with spinal cord injury to determine the safety and efficacy of this procedure in this group of patients. The anterior cingulate cortex is involved not only in the regulation of pain but also in emotional and autonomic nervous system regulation, which the investigators will monitor closely to determine the nature of any effects that this procedure might cause.

    Potential benefits

    Main benefits

    Pain

    Additional benefits

    General health

    Mental health

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more

    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 1 May 2021
    • Organisation
    • St George's, University of London
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 1 May 2021
    • Organisation
    • St George's, University of London

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more