Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05084170 |
| Other study ID # |
2021.0050 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2021 |
| Est. completion date |
April 30, 2024 |
Study information
| Verified date |
October 2021 |
| Source |
St George's, University of London |
| Contact |
Alexander Alamri |
| Phone |
020 8672 1255 |
| Email |
aalamri[@]sgul.ac.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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.
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.
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.
