NCT06794242

Brief 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. 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
10mo left

Started Apr 2025

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress58%
Apr 2025May 2027

First Submitted

Initial submission to the registry

January 21, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 27, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

2.1 years

First QC Date

January 21, 2025

Last Update Submit

January 21, 2025

Conditions

Keywords

Neuropathic painSpinal cord injuryBody representationVirtual realityQuality of life

Outcome Measures

Primary Outcomes (1)

  • DiffĂ©rences 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)

    From baseline up to a maximum of 2 weeks

Study Arms (2)

Patients

Spinal cord injury subjects

Other: Body representation

Controle

Healthy Subjects

Other: Body representation

Interventions

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.

ControlePatients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Spinal cord injury and volontary subjects

You may qualify if:

  • 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:
  • 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.

You may not qualify if:

  • 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
  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pierre Wertheimer Neurological Hospital

Bron, France, 69500, France

Location

Henry Gabrielle Hospital

Saint-Genis-Laval, France, 69230, France

Location

MeSH Terms

Conditions

Spinal Cord InjuriesNeuralgia

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesPeripheral Nervous System DiseasesNeuromuscular DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Anne-Laure CHARLOIS

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2025

First Posted

January 27, 2025

Study Start

April 1, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

January 27, 2025

Record last verified: 2025-01

Locations