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Virtual Walking and Neuromulation to Reduce Neuropathic Pain After a Spinal Cord Injury

Pas encore en recrutement
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L'étude clinique NCT07254767 est un essai interventionnel pour Douleur neuropathique. Son statut actuel est : pas encore en recrutement. Le recrutement est prévu pour commencer le 1 décembre 2025, avec un objectif de 10 participants. Dirigé par Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal, l'essai devrait être terminé d'ici le 1 septembre 2027. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 28 novembre 2025.
Résumé succinct
The goal of this single-subject design is to evaluate an intervention combining neuromodulation, virtual reality, and muscle vibration to reduce neuropathic pain in individuals following a spinal cord injury.

The investigators aim to quantify the effects of the intervention on the intensity and characteristics of neuropathic pain, as well as its impact on daily functioning in individuals undergoing SCI rehabilitation. Additionally, the investigators seek to gain a better understanding of participants' experiences with the intervention by exploring effects not captured by standardized questionnaires, and by examining the role and meaning of the intervention in their management and experience of pain.

Finally, the investigators aim to assess the feasibility and clinical relevance of implementing this intervention in a rehabilitation setting.

All participants living with neuropathic pain following a spinal cord injury will take part in ten intervention sessions. They will also be invited to complete standardized questionnaires and participate in a semi-structured interview. In addition, their clinicians will be invited to participate in a focus group.

Titre officiel

Combination of Visuo-proprioceptive Virtual Walking and Neuromodulation to Reduce Neuropathic Pain in Individuals With Spinal Cord Injury

Conditions
Douleur neuropathique
Publications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:
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Autres identifiants de l'essai
  • CRIR-2025-2084
Numéro NCT
NCT07254767
Date de début (réel)
2025-12-01
Dernière mise à jour publiée
2025-11-28
Date de fin (estimée)
2027-09
Inscription (estimée)
10
Type d'essai
Interventionnel
PHASE
N/A
Statut
Pas encore en recrutement
Mots clés
neuropathic pain
spinal cord injury
mixed methods
single subject design
tDCS
virtual reality
muscle vibration
Objectif principal
Traitement
Plan d'attribution
N/A
Modèle d'intervention
Groupe unique
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
Expérimental3-Phase Arm
Using repeated measurements over time, in three phases, i.e. an observation phase A, an intervention phase B and a post-intervention follow-up phase C, each participant will be his or her own control. Phase A : consists of an observational period without intervention, aimed at establishing a baseline and gaining a clearer understanding of the individual characteristics and patterns of neuropathic pain in each participant. Phase B : The intervention will be provided during Phase B. The intervention consists of starting neuromodulation 5min with tDCS alone, then adding virtual walking (virtual reality + corresponding somatosensory stimulation, via muscle vibration in the lower limbs) for the last 15min Phase C: follow up until 6monts post the end of the intervention.
Transcranial Direct Current Stimulation (TDCS) Combined with Virtual Reality and Muscle Vibration
tDCS will be delivered over the primary motor cortex (M1) to maximize the analgesic effect. The cathode will be positioned over the suborbital region, and the anode over M1 (position C3 or C4 of the international 10-20 system). A 2 mA direct current will be applied. Participants will observe, through virtual reality goggles (HTC Vive), an avatar walking from a first-person perspective, synchronized with the vibration pattern. Twelve vibrators will be placed transversely and bilaterally over the tendons of the main flexors and extensors of the lower limbs. The pattern used to trigger the vibrators is based on the natural sequence of gait movement. Muscle vibration induces a perception of movement in the direction of muscle elongation. The target frequency of the vibrators will be 80 Hz. The session will begin with 5 minutes of tDCS alone, and then for the last 15minutes the investigators will combine tDCS, virtual reality and muscle vibration.
Critère principal d'évaluation
Critères d'évaluationDescription de critèresPériode
Pain intensity
Pain intensity will be measured with Numeric rating scale, an 11-point scale to measure pain intensity, ranging from 0 (no pain) to 10 (worst possible pain). In the case of pain after spinal cord injury, the minimum clinically significant change would be around 1.8 points. Test-retest reliability ranged from 0.63 to 0.92, with intra- and inter-rater reliability of 0.84-0.98
Phase A (baseline): once daily from Day 1 to Day 7 Phase B (intervention): before and after each session, 2-3 sessions per week, for up to 4 weeks (10 sessions total). Phase C (follow up): at 1 month and 4 months after the end of the intervention.
Critère secondaire d'évaluation
Critères d'évaluationDescription de critèresPériode
Pain interference
The investigators extracted the interference section containing 3 items from the "international spinal cord injury pain basic data set data collection form - Version 3.0" in order to measure pain interference on daily activities, mood and sleep over the last 7 days. For each self-administered question, interference is measured on a scale from 0 (no interference) to 10 (maximum interference). The total score ranges from 0 to 30, a higher score means a greater pain interference.This questionnaire has been validated in people after spinal cord injury.
Phase A (baseline): Day 1 and Day 7. Phase B (intervention): after session 5 (week 2) and session 10 (week 4). (10 sessions total, 2-3 per week, for up to 4 weeks) Phase C (follow up) : at 1 month and 4 months after the end of the intervention.
Pain characteristics
Pain characteristics measured with PainDETECT. A tool initially developed to detect neuropathic components in people with chronic pain in the lumbar region. This questionnaire is increasingly used for other conditions, including post-spinal cord injury, helping to establish an individualized pain profile. It is also used in brain imaging studies. There are 9 items, 7 on sensory characteristics and 2 on temporal and spatial characteristics. It is scored from 0 to 38. A total of 19 or more indicates a high probability of having a neuropathic component.
Phase A (baseline): Day 1 and Day 7. Phase B (intervention): after session 5 (week 2) and session 10 (week 4). (10 sessions total, 2-3 per week, for up to 4 weeks) Phase C (follow up): at 1 month and 4 months after the end of the intervention.
Participant satisfaction rating for the Intervention
The research team developed a questionnaire to assess overall satisfaction with the intervention, as well as satisfaction with the timing, frequency, duration, content, and format of the sessions. There are 9 items, the satisfaction related to each item is scored on a scale 0 (not at all satisfied) to 10 (extremely satisfied). The total score ranges from 0 to 90, a higher score means a greater satisfaction of the participant regarding the intervention.
At the 10th (final) session (during phase B), in Week 4, assuming 10 sessions are conducted at a frequency of 2-3 per week.
Qualitative themes from semi-structured interviews on perceived effects, embodiment, feasibility, and personal impact of the intervention in the participant with neuropathic pain after a spinal cord injury (SCI)
Semi-structured interviews will be conducted with participants with neuropathic pain after a SCI. Each interview will last approximately 60 minutes and will follow a guide developed to structure the discussion. Thematic areas will include rehabilitation needs, overall experience with the intervention, perceived effects, embodiment, feasibility, suggestions regarding both positive and negative aspects, and for improving the intervention (for example in terms of effects or feasibility). How the intervention contributes to individuals' self-perception and interpretation of their pain experience will be also investigated. These interviews will be audio-recorded.
At the 10th (final) session (phase B), in week 4, assuming 10 sessions are conducted at a frequency of 2-3 per week
Qualitative themes identified through focus groups with clinicians on the perceived role, implementation, and impact of the intervention
Focus group will be conducted with clinicians. Each interview will last approximately 90 minutes and will follow a guide developed to structure the discussion. Thematic areas will include the role of the intervention in patient care, clinical relevance, necessary changes and tools kit for implementation, perceived changes observed in patients, as well as both positive and negative aspects.
3 to 6months after the end of the intervention
Intervention sessions adherence rate
Adherence to intervention sessions will be collected. It will be calculated as a percentage: the number of sessions completed divided by the number of sessions planned, multiplied by 100. The total score ranges from 0% to 100%, with higher scores indicating greater adherence to the sessions.
At the end of phase B, in week 4, assuming 10 sessions are conducted at a frequency of 2-3 per week
Rate of submission of baseline questionnaires
The rate of submission of the evaluation questionnaires will be collected. It will be calculated as a percentage: the number of questionnaires completed divided by the number of questionnaires expected (phase A), multiplied by 100. The total score ranges from 0% to 100%, with higher scores indicating greater adherence to the questionnaire.
When the participant has completed phase A. In phase A, the protocole includes 7 times of evaluation Day 1 to Day 7.
Recruitment rate
The investigators will calculate the recruitment rate as the percentage of participants who actually enrolled in the study out of the total number of potential participants who were approached and expressed interest,multiplied by 100. The total score ranges from 0% to 100%, with higher scores indicating greater recruitment rate.
At the end of the project, after all participants have been recruited (in 2 years).
participants' perception of walking during the session
After each intervention session, the investigators will ask participants to rate their perception of walking during the intervention stimulation using a numeric rating scale between 0 "The perception was not at all a perception of gait motion" and 10 "The perception was definitely a perception of gait motion". If the score is below 5/10, open-ended questions such as "What did you feel during the sessions?" and "How would you describe your sensations?" to explore whether participants experienced a perception of walking, and to rate how strong that perception was on a scale from 0 to 10.
During phase B (intervention): after each intervention session, 2-3 sessions per week, for up to 4 weeks (10 sessions total)
The session duration with the technologies (both installation and treatment)
The total session duration, including the time required for installation and the actual treatment using the technologies, will be documented. Based on preliminary trials with partner patients, investigators expect an average duration of 40 minutes (20 minutes for installation and 20 minutes for treatment). Any deviations from this expected duration, including delays, will be documented and used to assess the feasibility of the project.
During phase B (intervention): for each session, 2-3 sessions per week, for up to 4 weeks (10 sessions total)
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
  • over 18 years old
  • a score of ≥ 4/10 on the Douleur Neuropathique en 4 Questions (DN4)
  • classified AIS A to D
  • neuropathic pain with an intensity of ≥ 4/10 on the simple numerical rating scale (This threshold is often chosen to better observe a potential analgesic effect)

The main exclusion criteria are contraindications to tDCS and virtual reality

  • pregnancy,
  • epilepsy,
  • cancer,
  • pacemaker,
  • metallic implants in the brain or eyes,
  • uncontrolled severe headaches,
  • uncontrolled psychotic disorders,
  • open scalp wounds,
  • severe visual impairments. If participants have suffered a major traumatic brain injury with significant cognitive impairments, inclusion in the study will depend on the medical team's judgment. Finally, participants with allodynia in the areas where vibrators will be placed will not be included in the protocol
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal logoCentre for Interdisciplinary Research in Rehabilitation of Greater Montreal
Partie responsable de l'essai
Cyril Duclos, Investigateur principal, Professor, Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
Aucune donnée de contact disponible