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

NCT07254767 | Not Yet Recruiting

• 1 other identifier: CRIR-2025-2084
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Neuropathic Pain

Keywords

neuropathic pain; spinal cord injury; mixed methods; single subject design; tDCS; virtual reality; muscle vibration

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (10)

• Pain interference

  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

  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

  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)

  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

  3 to 6months after the end of the intervention

Study Arms (1)

3-Phase Arm

EXPERIMENTAL

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.

Device: Transcranial Direct Current Stimulation (tDCS) combined with virtual reality and muscle vibration

Interventions

Transcranial Direct Current Stimulation (tDCS) combined with virtual reality and muscle vibration DEVICE

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.

3-Phase Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• pregnancy,
• epilepsy,
• cancer,
• pacemaker,
• metallic implants in the brain or eyes,
• uncontrolled severe headaches,
• uncontrolled psychotic disorders,
• open scalp wounds,

Sponsors & Collaborators

• Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal: lead

Related Publications (23)

• 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 BACKGROUND

• 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.

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• 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.

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• 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.

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• 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 BACKGROUND

• 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 BACKGROUND

• 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.

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• 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.

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• Luo L, Liu Y, Huang L, Ming Z, Cao J. Neuropathic Pain Experience and Self-Management Strategies of Spinal Cord Injury Patients: A Meta-Synthesis of Qualitative Studies. Pain Manag Nurs. 2025 Jul 26:S1524-9042(25)00215-2. doi: 10.1016/j.pmn.2025.06.015. Online ahead of print.

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• Loh E, Mirkowski M, Agudelo AR, Allison DJ, Benton B, Bryce TN, Guilcher S, Jeji T, Kras-Dupuis A, Kreutzwiser D, Lanizi O, Lee-Tai-Fuy G, Middleton JW, Moulin DE, O'Connell C, Orenczuk S, Potter P, Short C, Teasell R, Townson A, Widerstrom-Noga E, Wolfe DL, Xia N, Mehta S. The CanPain SCI clinical practice guidelines for rehabilitation management of neuropathic pain after spinal cord injury: 2021 update. Spinal Cord. 2022 Jun;60(6):548-566. doi: 10.1038/s41393-021-00744-z. Epub 2022 Feb 5.

  PMID: 35124700 BACKGROUND

• Li C, Jirachaipitak S, Wrigley P, Xu H, Euasobhon P. Transcranial direct current stimulation for spinal cord injury-associated neuropathic pain. Korean J Pain. 2021 Apr 1;34(2):156-164. doi: 10.3344/kjp.2021.34.2.156.

  PMID: 33785667 BACKGROUND

• Leemhuis E, Esposito RM, De Gennaro L, Pazzaglia M. Go Virtual to Get Real: Virtual Reality as a Resource for Spinal Cord Treatment. Int J Environ Res Public Health. 2021 Feb 13;18(4):1819. doi: 10.3390/ijerph18041819.

  PMID: 33668438 BACKGROUND

• Le Franc S, Bonan I, Fleury M, Butet S, Barillot C, Lecuyer A, Cogne M. Visual feedback improves movement illusions induced by tendon vibration after chronic stroke. J Neuroeng Rehabil. 2021 Oct 30;18(1):156. doi: 10.1186/s12984-021-00948-7.

  PMID: 34717672 BACKGROUND

• Labbe, D. R., Kouakoua, K., Aissaoui, R., Nadeau, S., & Duclos, C. (2021). Proprioceptive Stimulation Added to a Walking Self-Avatar Enhances the Illusory Perception of Walking in Static Participants. Frontiers in Virtual Reality, 2. https://www.frontiersin.org/article/10.3389/frvir.2021.557783

  BACKGROUND

• Krasny-Pacini A, Evans J. Single-case experimental designs to assess intervention effectiveness in rehabilitation: A practical guide. Ann Phys Rehabil Med. 2018 May;61(3):164-179. doi: 10.1016/j.rehab.2017.12.002. Epub 2017 Dec 15.

  PMID: 29253607 BACKGROUND

• Jutzeler CR, Huber E, Callaghan MF, Luechinger R, Curt A, Kramer JL, Freund P. Association of pain and CNS structural changes after spinal cord injury. Sci Rep. 2016 Jan 6;6:18534. doi: 10.1038/srep18534.

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• Imai R, Osumi M, Morioka S. Influence of illusory kinesthesia by vibratory tendon stimulation on acute pain after surgery for distal radius fractures: a quasi-randomized controlled study. Clin Rehabil. 2016 Jun;30(6):594-603. doi: 10.1177/0269215515593610. Epub 2015 Jul 21.

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• Hallstrom H, Norrbrink C. Screening tools for neuropathic pain: can they be of use in individuals with spinal cord injury? Pain. 2011 Apr;152(4):772-779. doi: 10.1016/j.pain.2010.11.019. Epub 2011 Jan 26.

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• Gupta A, Scott K, Dukewich M. Innovative Technology Using Virtual Reality in the Treatment of Pain: Does It Reduce Pain via Distraction, or Is There More to It? Pain Med. 2018 Jan 1;19(1):151-159. doi: 10.1093/pm/pnx109.

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• Freynhagen R, Tolle TR, Gockel U, Baron R. The painDETECT project - far more than a screening tool on neuropathic pain. Curr Med Res Opin. 2016 Jun;32(6):1033-57. doi: 10.1185/03007995.2016.1157460. Epub 2016 Mar 11.

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• Finnerup NB. Neuropathic pain and spasticity: intricate consequences of spinal cord injury. Spinal Cord. 2017 Dec;55(12):1046-1050. doi: 10.1038/sc.2017.70. Epub 2017 Jul 11.

  PMID: 28695904 BACKGROUND

• Duclos C, Kemlin C, Lazert D, Gagnon D, Dyer JO, Forget R. Complex muscle vibration patterns to induce gait-like lower-limb movements: proof of concept. J Rehabil Res Dev. 2014;51(2):245-51. doi: 10.1682/JRRD.2013.04.0079.

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• Austin PD, Siddall PJ. Virtual reality for the treatment of neuropathic pain in people with spinal cord injuries: A scoping review. J Spinal Cord Med. 2021 Jan;44(1):8-18. doi: 10.1080/10790268.2019.1575554. Epub 2019 Feb 1.

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MeSH Terms

Conditions

Neuralgia; Spinal Cord Injuries

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single subject design with mixed methods

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: November 28, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share