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RecruitingNCT06010251Updated Nov 21, 2025

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

An interventional study of tDCS and bodily illusions in Spinal Cord Injuries and Neuropathic Pain, sponsored by University of Miami. Recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-11-21.

Sponsored by University of Miami · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2023; still recruiting 2 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Spinal Cord Injuries
  • Neuropathic Pain
03

In context

Spinal Cord Injuries

1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.

This study's planned enrollment of 30 is above the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

The study will be open to people of any ethnicity, racial background, and gender.

Inclusion criteria

Inclusion criteria:

SCI with Pain:

  1. Men or women
  2. fluent in English
  3. 18-70 years of age who have: (3a) Complete and incomplete SCI, level of injury (above L1); (3b) Persistent neuropathic pain started after the injury for a minimum of three months prior to entering the study that is at least moderate in severity, defined as ≥ 4 on a Numeric Rating Scale (NRS) ranging 0 to 10.

Exclusion criteria

Exclusion criteria:

Participants will be excluded if they have:

  1. Major psychiatric disease/disorder (self-reported);
  2. a significant neurological trauma (self-reported) other than SCI;
  3. a recent (one-year) history of alcohol or drug abuse assessed by the Drug Abuse Screening Test (DAST-10)
  4. history of visual and hearing loss not corrected
  5. history of epilepsy or seizures
  6. any metal implants in the head, or implanted devices such as cochlea implants or cardiac pacemakers.

We will not include any special population like:

Adults unable to consent Individuals who are not yet adults (infants, children, teenagers) Pregnant women Prisoners

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    SCI with pain

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

    Other: tDCS and bodily illusions

Interventions

  • OthertDCS and bodily illusions

    Participants will be required to perform (in person) 10 interventions over a time frame of 2-4 weeks. They can perform this everyday or for a minimum of 2-3 times per week over 4 weeks. Two types of illusions will be used 15 min each, the rubber hand illusion and the walking illusion to target upper and lower limbs. These procedures will impact the body representation of the participants resulting in bodily illusions.

06

What researchers measure

Primary outcomes

  1. Change in neuropathic pain severity assessed by Neuropathic Pain Symptom Inventory (NPSI)

    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.

    Time frame: Baseline, up to 4 weeks

  2. Change in neuropathic pain interference assessed by pain interference questionnaire.

    The questionnaire consists in a numerical rating of pain interference ranging from 0= No Interference to 10=Extreme interference with activities, mood and sleep

    Time frame: Baseline, up to 4 weeks

  3. Changes associated with sensory function/dysfunction assessed by quantitative sensory testing

    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.

    Time frame: Baseline, up to 4 weeks

Secondary outcomes

  1. Change in manageable pain assessed by days of manageable pain questionnaire.

    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.

    Time frame: Baseline, up to 4 weeks

  2. Changes of psychosocial assessed by Multidimensional Pain Inventory (pain severity subscale)

    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.

    Time frame: Baseline, up to 4 weeks

  3. Change in Global impression of changes by PGIC questionnaire

    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).

    Time frame: Baseline, up to 4 weeks

07

Study locations

1 of 1 sites recruiting
  • University of Miami
    Miami, Florida 33136, United States
    • Eva Widerstrom-Noga, PhD · Contact · ewiderstrom-noga@med.miami.edu · 305-243-7125
    • Roberta Vastano, PhD · Contact · rxv331@miami.edu · 7542073627
    • Eva Widerstrom-Noga, PhD · Principal investigator
    • Roberta Vastano, PhD · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06010251
Lead sponsor
University of Miami
Responsible party
Eva Widerstrom-Noga (Professor, University of Miami) — Principal investigator
First posted
Aug 24, 2023
Start date
Oct 17, 2023
Primary completion
Oct 20, 2026 (estimated)
Completion
Oct 20, 2026 (estimated)
Last update
Nov 21, 2025

Study contacts

Eva Widerstrom-Noga, PhD
Contact
ewiderstrom-noga@med.miami.edu
(305)243-7125
Roberta Vastano, PhD
Contact
rxv331@miami.edu
754 207 3627
Eva Widerstrom-Noga, PhD
principal investigator · University of Miami

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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