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

Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

Status: Not yet enrolling

Conditions: Neuropathic Pain

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07254767

CRIR-2025-2084

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

3-Phase Arm

Experimental group

Description:

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.

Treatment:

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