Utility of Multisensory Body-Representation in Spinal Cord Injury (SCI) With Pain

Not Applicable

Recruiting

• Conditions: Neuropathic Pain; Spinal Cord Injuries
• Interventions: Other: tDCS and bodily illusions

• Registration Number: NCT06010251
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-18
• Study First Submitted QC: 2023-08-18
• Study First Posted: 2023-08-24
• Study Start: 2023-10-17
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-11
• Primary Completion: 2026-10-20
• Study Completion: 2026-10-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SCI with pain	tDCS and bodily illusions	Participants will undergo 2-4 weeks of combined intervention including transcranial direct current stimulation (tDCS) and bodily illusions (10 sessions total).

Primary Outcome Measures

Name	Time	Method
Changes associated with sensory function/dysfunction assessed by quantitative sensory testing	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 interference assessed by pain interference questionnaire.	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
Change in neuropathic pain severity assessed by Neuropathic Pain Symptom Inventory (NPSI)	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.

Secondary Outcome Measures

Name	Time	Method
Changes of psychosocial assessed by Multidimensional Pain Inventory (pain severity subscale)	Baseline, up to 4 weeks	Multidimensional Pain Inventory assesses the psychosocial impact of pain. This scale consists of three questions: 1) pain at the present moment; 2) pain during the past week and 3) suffering because of pain.; The range of the responses are from 0 (no pain or suffering) to 6 (extreme pain or suffering) and the scores of these three questions will be summed to obtain a composite pain severity score.
Change in Global impression of changes by PGIC questionnaire	Baseline, up to 4 weeks	Patients' Global Impression of Changes (PGIC) assesses patients' perceptions of changes following treatment. It is a 7-point verbal scale, with the options ranging from "very much improved" (3), "much improved" (2), "minimally improved" (1), "no change" (0), "minimally worsened" (-1) "much worsened" (-2), and "very much worsened" (-3).
Change in manageable pain assessed by days of manageable pain questionnaire.	Baseline, up to 4 weeks	This item specifies the total number of days with pain during the last 7 days, including today, and the response categories ranges from 0=none to 7=seven days.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States