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Neuropathic PainNCT07254767

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

A study testing Transcranial Direct Current Stimulation (tDCS) combined with virtual reality and muscle vibration in people with Neuropathic Pain, run by Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neuropathic Pain
What is being tested?
Transcranial Direct Current Stimulation (tDCS) combined with virtual reality and muscle vibration
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
No sites listed yet
Study dates
1 Dec 2025to Sep 2027
Phase
Interventional
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,
Show all 14Show fewer
  • 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

Who cannot join

None listed.

About this study

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

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.

Read more

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.

Being tested
Transcranial Direct Current Stimulation (tDCS) combined with virtual reality and muscle vibration
Keywords
neuropathic pain, spinal cord injury, mixed methods, single subject design, tDCS, virtual reality, muscle vibration
Medical subject headings
Neuralgia, Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcranial Direct Current Stimulation (tDCS) combined with virtual reality and muscle vibrationDevice

    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.

Study groups in NCT07254767
Study groupRoleWhat they receive
3-Phase ArmExperimentalUsing 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.
Receives: Device: Transcranial Direct Current Stimulation (tDCS) combined with virtual reality and muscle vibration

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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)
  1. 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.

    Measured: 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.

  2. 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.

    Measured: 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.

  3. 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.

    Measured: At the 10th (final) session (during phase B), in Week 4, assuming 10 sessions are conducted at a frequency of 2-3 per week.

  4. 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.

    Measured: At the 10th (final) session (phase B), in week 4, assuming 10 sessions are conducted at a frequency of 2-3 per week

  5. 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.

    Measured: 3 to 6months after the end of the intervention

  6. 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.

    Measured: At the end of phase B, in week 4, assuming 10 sessions are conducted at a frequency of 2-3 per week

  7. 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.

    Measured: When the participant has completed phase A. In phase A, the protocole includes 7 times of evaluation Day 1 to Day 7.

  8. 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.

    Measured: At the end of the project, after all participants have been recruited (in 2 years).

  9. 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.

    Measured: During phase B (intervention): after each intervention session, 2-3 sessions per week, for up to 4 weeks (10 sessions total)

  10. 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.

    Measured: During phase B (intervention): for each session, 2-3 sessions per week, for up to 4 weeks (10 sessions total)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2025
  2. Study start1 Dec 2025 (estimated)
  3. Primary completionMay 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single subject design with mixed methods
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07254767
Sponsor's protocol ID
CRIR-2025-2084
Status last verified
Nov 2025
First submitted
18 Sep 2025
Last updated
28 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual quantitative data will be included in the articles reporting the results of the study.

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 31551731
  • 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. 2026 Apr;27(2):e140-e152. doi: 10.1016/j.pmn.2025.06.015. Epub 2025 Jul 28.

    PubMed 40716978
  • 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.

    PubMed 35124700
  • 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.

    PubMed 33785667
  • 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.

    PubMed 33668438
  • 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.

    PubMed 34717672
  • 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

  • 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.

    PubMed 29253607

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial Direct Current Stimulation (tDCS) combined with virtual reality and muscle vibration in people with Neuropathic Pain, run by Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal.

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 14 inclusion and 0 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 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07254767, which also lists 23 linked publications.

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 28 Nov 2025.

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