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

NCT05084170 | Unknown

• 1 other identifier: 2021.0050
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• The primary outcome will be a change in pain scores (Neuropathic pain scale and Spinal cord injury pain inventory scores) at 3 and 12 months.

  12 months

Secondary Outcomes (2)

• Improvement in health-related quality of life as measured by EuroQol 5 Dimension questionnaire.

  12 months

• Connectomic changes in brain pain networks as assessed by magnetic resonance imaging.

  12 months

Interventions

Bilateral anterior cingulotomy PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with neuropathic pain secondary to spinal cord injury, refractory to analgesia and other pain interventions

You may qualify if:

• Diagnosis of complete or partial spinal cord injury at any level
• Chronic neuropathic pain (for at least 12 months) resistant to conventional treatments or history of unacceptable side effects from conventional treatments.
• Age limits 18-70 years old

You may not qualify if:

• Traumatic brain injury
• Severe cognitive impairment
• Significant medical co-morbidity (e.g. coagulopathy)
• Radiofrequency lesioning or MRI incompatible device (e.g. baclofen pump or spinal cord stimulator) already in situ

Sponsors & Collaborators

• St George's, University of London: lead

Study Sites (1)

St. George's, University of London

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Neuralgia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Erlick Pereira

  St George's, University of London

  STUDY CHAIR

Central Study Contacts

Alexander Alamri

CONTACT

020 8672 1255; aalamri@sgul.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: October 19, 2021
• Study Start: May 1, 2021
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2024
• Last Updated: October 19, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)