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

Official title

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

Overview

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.

Interventions

• Device 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

Primary outcome measures

• Pain intensity [Time frame: 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.]

Secondary outcome measures (10)

• Pain interference [Time frame: 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 [Time frame: 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 [Time frame: 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) [Time frame: 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 [Time frame: 3 to 6months after the end of the intervention]
• Intervention sessions adherence rate [Time frame: 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 [Time frame: When the participant has completed phase A. In phase A, the protocole includes 7 times of evaluation Day 1 to Day 7.]
• Recruitment rate [Time frame: At the end of the project, after all participants have been recruited (in 2 years).]
• participants' perception of walking during the session [Time frame: 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) [Time frame: During phase B (intervention): for each session, 2-3 sessions per week, for up to 4 weeks (10 sessions total)]

Eligibility criteria

Inclusion criteria

• 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)

Exclusion Criteria: 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Austin PD, Craig A, Middleton JW, Tran Y, Costa DSJ, Wrigley PJ, Siddall PJ. The short-term effects of head-mounted virtual-reality on neuropathic pain intensity in people with spinal cord injury pain: a randomised cross-over pilot study. Spinal Cord. 2021 Jul;59(7):738-746. doi: 10.1038/s41393-020-00569-2. Epub 2020 Oct 19. PMID 33077900
• Burke D, Fullen BM, Stokes D, Lennon O. Neuropathic pain prevalence following spinal cord injury: A systematic review and meta-analysis. Eur J Pain. 2017 Jan;21(1):29-44. doi: 10.1002/ejp.905. Epub 2016 Jun 24. PMID 27341614
• Chi B, Chau B, Yeo E, Ta P. Virtual reality for spinal cord injury-associated neuropathic pain: Systematic review. Ann Phys Rehabil Med. 2019 Jan;62(1):49-57. doi: 10.1016/j.rehab.2018.09.006. Epub 2018 Oct 9. PMID 30312665
• Widerstrom-Noga E, Biering-Sorensen F, Bryce T, Cardenas DD, Finnerup NB, Jensen MP, Richards JS, Siddall PJ. The international spinal cord injury pain basic data set. Spinal Cord. 2008 Dec;46(12):818-23. doi: 10.1038/sc.2008.64. Epub 2008 Jun 3. PMID 18521092
• Ummels D, Cnockaert E, Timmers I, den Hollander M, Smeets R. Use of Virtual Reality in Interdisciplinary Multimodal Pain Treatment With Insights From Health Care Professionals and Patients: Action Research Study. JMIR Rehabil Assist Technol. 2023 Nov 10;10:e47541. doi: 10.2196/47541. PMID 37948109
• Tapin A, Duclos NC, Jamal K, Duclos C. Perception of gait motion during multiple lower-limb vibrations in young healthy individuals: a pilot study. Exp Brain Res. 2021 Nov;239(11):3267-3276. doi: 10.1007/s00221-021-06199-1. Epub 2021 Aug 31. PMID 34463827
• Sreeraj VS, Arumugham SS, Venkatasubramanian G. Clinical Practice Guidelines for the Use of Transcranial Direct Current Stimulation in Psychiatry. Indian J Psychiatry. 2023 Feb;65(2):289-296. doi: 10.4103/indianjpsychiatry.indianjpsychiatry_496_22. Epub 2023 Jan 30. No abstract available. PMID 37063621
• Matamala-Gomez M, Donegan T, Bottiroli S, Sandrini G, Sanchez-Vives MV, Tassorelli C. Immersive Virtual Reality and Virtual Embodiment for Pain Relief. Front Hum Neurosci. 2019 Aug 21;13:279. doi: 10.3389/fnhum.2019.00279. eCollection 2019. PMID 31551731

Identifiers

NCT: NCT07254767 · CRIR-2025-2084

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗