Spinal Cord InjuryREPTAILLENCT06794242
Body Representation and Neuropathic Pain in Spinal Cord Injury
An observational study of Spinal Cord Injury, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
Chronic pain is one of the main complications of spinal cord injury, has a very negative impact on quality of life, and persists over time despite the use of analgesic treatments. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Body representation
- How many people
- 80 participants
- Where
- 2 sitesFrance
- Study dates
- Apr 2025to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Spinal cord injury and volontary subjects
Who may be able to join
- Patients group:
- Men and women between the ages of 18 and 65;
- Have normal or corrected eyesight;
- Have a spinal cord lesion resulting in total or partial loss of tactile and proprioceptive sensitivity and motor skills in the lower limbs.
- have given their free and informed consent in writing, after having been informed orally and in writing of the study's progress.
- Control group:
Show all 9Show fewer
- Men and women between 18 and 65 years of age
- Have normal or corrected eyesight
- Have given their free and informed written consent after having been informed orally and in writing of the course of the study.
Who cannot join
- Patients Group:
- People with a diagnosis of Eating Disorder
- People with a diagnosis of a psychiatric disorder that can modify body representations
- People who suffer from physiological discomfort when using gaming headsets or virtual reality
- People under psychiatric care
- Illiterate people
Show all 23Show fewer
- Pregnant women, women in labour or breastfeeding mothers
- Persons deprived of their liberty by judicial or administrative decision
- Adults under legal protection (guardianship, curatorship)
- Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
- Control group:
- People with an eating disorder diagnosis
- People diagnosed with psychiatric disorders that can modify body representations
- People who suffer from physiological discomfort when using gaming headsets or virtual reality
- People under psychiatric care
- Illiterate people
- People with functional neurological motor disorders and/or partial or complete deficits and/or abnormal movements
- People with sensitivity problems in the lower limbs
- Pregnant women, women in labour or breastfeeding mothers
- Persons deprived of their liberty by judicial or administrative decision
- Persons admitted to a health or social establishment for purposes other than research
- Adults under legal protection (guardianship, curatorship)
- Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Anne-Laure CHARLOIS contact
France2 sites
Pierre Wertheimer Neurological Hospital
Bron, France, 69500
Jacques LUAUTE, Pr, (0)4.78.86.50.64 ext. +33, jacques.luaute@chu-lyon.fr
Henry Gabrielle Hospital
Saint-Genis-Laval, France, 69230
Jacques LUAUTE, Pr, (0)4.78.86.50.64 ext. +33, jacques.luaute@chu-lyon.fr
About this study
Official title: Investigating the Link Between Body Representation and Neuropathic Pain in Patients with Spinal Cord Injury
Chronic pain is one of the main complications of spinal cord injury, has a very negative impact on quality of life, and persists over time despite the use of analgesic treatments. Several types of pain are possible in patients with spinal cord injury, and neuropathic pain (pain caused by damage to the spinal cord, in this case) is one of the most difficult to treat, even with medication. Following an injury to the spinal cord, it is possible for the representation of the body to change as a result of sensorimotor deficits, prolonged changes in body posture and altered mobility. At present, the causes of chronic pain after spinal cord injury remain poorly understood and debated, but one hypothesis suggests that changes in body representation may play a key role in the development or worsening of neuropathic pain. To test this hypothesis, we will assess the perception of spinal cord injured patients (and a group of controls) of the size of their legs using a virtual reality device. This measurement will enable us to examine whether under- or over-estimation of leg length correlates with the presence of neuropathic pain in patients. Chronic pain in people with spinal cord injury is associated with an increased risk of stress, depression and anxiety, and understanding and treating neuropathic pain in people with spinal cord injury is a major issue in their management.
- Conditions
- Spinal Cord Injury
- Being tested
- Body representation
- Keywords
- Neuropathic pain, Spinal cord injury, Body representation, Virtual reality, Quality of life
- 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.
Body representationOther
All the participants (controls and patients) in the study will follow the same experimental procedure, which consists of a single virtual reality session involving the estimation of leg length and an object.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Spinal cord injury subjects Receives: Other: Body representation | |
| Controle | Healthy Subjects Receives: Other: Body representation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Différences in leg length estimation between controls and patients in the length representation test.
We will measure the difference between the representation of the length of the lower limbs of controls and spinal cord injured patients. This difference will be assessed using the Point of Subjective Equality (defined as the size of the avatar's legs perceived by the participant as corresponding to the length of their legs) with a two-sample Mann Whitney test (two-tailed) (controls and patients)
Measured: From baseline up to a maximum of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study startApr 2025 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche de Neurosciences de Lyon
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794242
- Sponsor's protocol ID
- 69HCL24_0460
- Acronym
- REPTAILLE
- Status last verified
- Jan 2025
- First submitted
- 21 Jan 2025
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Link Between Body Representation and Neuropathic Pain in Patients with Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT06794242
- Acronym / sponsor ID
- REPTAILLE / 69HCL24_0460
- Conditions
- Spinal Cord Injury
- Keywords
- Neuropathic pain, Spinal cord injury, Body representation, Virtual reality, Quality of life
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- Centre de Recherche de Neurosciences de Lyon
- Study start
- Apr 2025 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 27 Jan 2025 (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.
Chronic pain is one of the main complications of spinal cord injury, has a very negative impact on quality of life, and persists over time despite the use of analgesic treatments. Several types of pain are possible in patients with spinal cord injury, and neuropathic pain (pain caused by damage to the spinal cord, in this case) is one of the most difficult to treat, even with medication. Following an injury to the spinal cord, it is possible for the representation of the body to change as a result of sensorimotor deficits, prolonged changes in body posture and altered mobility. At present, the causes of chronic pain after spinal cord injury remain poorly understood and debated, but one hypothesis suggests that changes in body representation may play a key role in the development or worsening of neuropathic pain. To test this hypothesis, we will assess the perception of spinal cord injured patients (and a group of controls) of the size of their legs using a virtual reality device. This measurement will enable us to examine whether under- or over-estimation of leg length correlates with the presence of neuropathic pain in patients. Chronic pain in people with spinal cord injury is associated with an increased risk of stress, depression and anxiety, and understanding and treating neuropathic pain in people with spinal cord injury is a major issue in their management.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Body representationSpinal cord injury subjects |
| Controle | – | Other: Body representationHealthy Subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Spinal cord injury and volontary subjects
Key inclusion criteria (9 listed)
- Men and women between the ages of 18 and 65;
- Have normal or corrected eyesight;
- Have a spinal cord lesion resulting in total or partial loss of tactile and proprioceptive sensitivity and motor skills in the lower limbs.
- have given their free and informed consent in writing, after having been informed orally and in writing of the study's progress.
- Men and women between 18 and 65 years of age
Key exclusion criteria (23 listed)
- People with a diagnosis of Eating Disorder
- People with a diagnosis of a psychiatric disorder that can modify body representations
- People who suffer from physiological discomfort when using gaming headsets or virtual reality
- People under psychiatric care
- Illiterate people
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 |
|---|---|---|
| Body representationAll the participants (controls and patients) in the study will follow the same experimental procedure, which consists of a single virtual reality session involving the estimation of leg length and an object. | Other | Controle, Patients |
Primary outcome
Différences in leg length estimation between controls and patients in the length representation test.
Time frame: From baseline up to a maximum of 2 weeks
We will measure the difference between the representation of the length of the lower limbs of controls and spinal cord injured patients. This difference will be assessed using the Point of Subjective Equality (defined as the size of the avatar's legs perceived by the participant as corresponding to the length of their legs) with a two-sample Mann Whitney test (two-tailed) (controls and patients)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Spinal Cord Injury
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
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.
Anne-Laure CHARLOIS contact
2 sites 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 Injury, run by Hospices Civils de Lyon at 2 sites in France.
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 9 inclusion and 23 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: opening soon, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacques LUAUTE, Pr ((0)4.78.86.50.64 ext. +33, jacques.luaute@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Différences in leg length estimation between controls and patients in the length representation test. (time frame: From baseline up to a maximum of 2 weeks). 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 27 Jan 2025.