Spinal Cord InjuriesCRNP-SCINCT05084170
Cingulotomy for Refractory Neuropathic Pain Following Spinal Cord Injury (CRNP-SCI)
An observational study of Spinal Cord Injuries and Neuropathic Pain, run by St George's, University of London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injuries, Neuropathic Pain
- What is being tested?
- Bilateral anterior cingulotomy
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2021to 30 Apr 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with neuropathic pain secondary to spinal cord injury, refractory to analgesia and other pain interventions
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
St. George's, University of London
London
Alexander Alamri, 020 8672 1255, aalamri@sgul.ac.uk
About this study
Official title: Cingulotomy for Refractory Neuropathic Pain Following Spinal Cord Injury
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Spinal Cord Injuries, Neuropathic Pain
- Being tested
- Bilateral anterior cingulotomy
- Medical subject headings
- Spinal Cord Injuries, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral anterior cingulotomyProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (2)
Improvement in health-related quality of life as measured by EuroQol 5 Dimension questionnaire.
Measured: 12 months
Connectomic changes in brain pain networks as assessed by magnetic resonance imaging.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start1 May 2021
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erlick Pereira, Study chair, St George's, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084170
- Sponsor's protocol ID
- 2021.0050
- Acronym
- CRNP-SCI
- Status last verified
- Oct 2021
- First submitted
- 17 Sep 2021
- Last updated
- 19 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cingulotomy for Refractory Neuropathic Pain Following Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05084170
- Acronym / sponsor ID
- CRNP-SCI / 2021.0050
- Conditions
- Spinal Cord Injuries, Neuropathic Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 19 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with neuropathic pain secondary to spinal cord injury, refractory to analgesia and other pain interventions
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral anterior cingulotomyStereotactic 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. | Procedure or surgery | – |
Primary outcome
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.
Time frame: 12 months
2 secondary outcomes
Improvement in health-related quality of life as measured by EuroQol 5 Dimension questionnaire.
Time frame: 12 months
Connectomic changes in brain pain networks as assessed by magnetic resonance imaging.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erlick Pereira study chair
St George's, University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries and Neuropathic Pain, run by St George's, University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander Alamri (020 8672 1255, aalamri@sgul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021.