Combination of Visuo-proprioceptive Virtual Walking and Neuromodulation to Reduce Neuropathic Pain in Individuals With Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 主要终点
- Pain intensity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •The main exclusion criteria are contraindications to tDCS and virtual reality
- •pregnancy,
- •epilepsy,
- •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
研究组 & 干预措施
3-Phase Arm
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.
干预措施: Transcranial Direct Current Stimulation (tDCS) combined with virtual reality and muscle vibration (Device)
结局指标
主要结局
Pain intensity
时间窗: 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.
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
次要结局
- 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)
- Intervention sessions adherence rate(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(When the participant has completed phase A. In phase A, the protocole includes 7 times of evaluation Day 1 to Day 7.)
- Recruitment rate(At the end of the project, after all participants have been recruited (in 2 years).)
- participants' perception of walking during the session(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)(During phase B (intervention): for each session, 2-3 sessions per week, for up to 4 weeks (10 sessions total))
研究者
Cyril Duclos
Professor
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal