Virtual Walking and Neuromulation to Reduce Neuropathic Pain After a Spinal Cord Injury
- Sponsor
- Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
- Study ID
- NCT07254767
- Status
- Not Yet Recruiting
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Conditions
- Neuropathic Pain
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Transcranial Direct Current Stimulation (tDCS) combined with virtual reality and muscle vibration — DEVICEtDCS 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 Details
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.
Key Dates
- First listed
- Nov 28, 2025
- Start date
- Dec 1, 2025
- Status verified
- Nov 2025
- Primary completion
- May 31, 2027
- Completion
- Sep 30, 2027
Study Design
- Enrollment
- 10 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: 3-Phase ArmUsing 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.
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. ]
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