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

NCT05084170 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2021-10-19

No results posted yet for this study

Summary

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 unmet need to treat people with refractory spinal injury related neuropathic pain. While neuropathic pain medications, baclofen pumps and spinal cord stimulation work for some patients, a significant number are refractory to these therapies. Chronic pain can contribute to loss of functional ability, mental health problems, and a worse quality of life.

Studies of functional neuroimaging have shown that the Anterior Cingulate Cortex (ACC) is a key structure in human pain perception, being part of a central pain neuromatrix or medial pain system, which includes thalamic nuclei and periaqueductal grey matter. A similar neuromatrix also including the insula is involved in the regulation of the autonomic nervous system, which explains the well-recognized interactions between pain and autonomic function. Moreover, it has been shown that the ACC is important for the emotional experience and thus the subjective intensity of pain, and it has a role in cognitive control processes for optimizing behaviour in the presence of pain.

Bilateral anterior cingulotomy has been demonstrated to be a safe and effective therapeutic option for patients with otherwise intractable pain syndromes of different origins, e.g., refractory pain due to cancer or stroke.

Although, cingulotomy has been shown to be a viable option in intractable pain of different origins, there remains a lack of evidence in patients with spinal cord injury and only scanty data are available in literature. Moreover, the effects of cingulotomy on mood, emotion processing, cognition and autonomic reactivity are not clear.

Conditions

  • Spinal Cord Injuries
  • Neuropathic Pain

Interventions

PROCEDURE

Bilateral anterior cingulotomy

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.

Sponsors & Collaborators

  • St George's, University of London

    lead OTHER

Principal Investigators

  • Erlick Pereira · St George's, University of London

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2023-04-30
Completion
2024-04-30

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 NCT05084170 on ClinicalTrials.gov