Mechanisms and Utility of Multisensory Body- Representation in SCI and SCI-Related Neuropathic Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Miami
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Changes associated with sensory function/dysfunction assessed by quantitative sensory testing
Study Overview
Brief Summary
The purpose of this study is to investigate the effectiveness of bodily illusions combined with transcranial direct current stimulation (tDCS) on neuropathic pain symptoms and sensory functions in participants with spinal cord injury (SCI) and neuropathic pain.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Changes associated with sensory function/dysfunction assessed by quantitative sensory testing
Time Frame: Baseline, up to 4 weeks
The sensory test assesses thermal thresholds and includes: cool detection threshold (CDT), warm detection threshold (WDT), cold pain threshold (CPT), hot pain threshold (HPT), all performed using the method of limits: 0 to 50 Celsius (ºC) all values will be reported in Celsius.
Change in neuropathic pain severity assessed by Neuropathic Pain Symptom Inventory (NPSI)
Time Frame: Baseline, up to 4 weeks
The NPSI is a self-reported, validated questionnaire that includes 10 items (on different pain sensations, e.g., burning, squeezing, electric-shock, etc.) used to evaluate the properties of neuropathic pain. Each item is scored on an 11-point NRS (0 meaning no symptom and 10 meaning worst symptom), with higher scores indicating more severe neuropathic pain symptoms.
Change in neuropathic pain interference assessed by pain interference questionnaire.
Time Frame: Baseline, up to 4 weeks
The questionnaire consists in a numerical rating of pain interference ranging from 0= No Interference to 10=Extreme interference with activities, mood and sleep
Secondary Outcomes
- Changes of psychosocial assessed by Multidimensional Pain Inventory (pain severity subscale)(Baseline, up to 4 weeks)
- Change in Global impression of changes by PGIC questionnaire(Baseline, up to 4 weeks)
- Change in manageable pain assessed by days of manageable pain questionnaire.(Baseline, up to 4 weeks)
Investigators
Eva Widerstrom-Noga
Professor
University of Miami