Spinal Cord InjuriesNCT06010251
Utility of Multisensory Body-Representation in Spinal Cord Injury (SCI) With Pain
A study testing tDCS and bodily illusions in people with Spinal Cord Injuries and Neuropathic Pain, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injuries, Neuropathic Pain
- What is being tested?
- tDCS and bodily illusions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2023to 20 Oct 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SCI with Pain:
- Men or women
- fluent in English
- 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.
Who cannot join
- Participants will be excluded if they have:
- Major psychiatric disease/disorder (self-reported);
- a significant neurological trauma (self-reported) other than SCI;
- a recent (one-year) history of alcohol or drug abuse assessed by the Drug Abuse Screening Test (DAST-10)
- history of visual and hearing loss not corrected
- history of epilepsy or seizures
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Eva Widerstrom-Noga, PhD, (305)243-7125, ewiderstrom-noga@med.miami.edu
Roberta Vastano, PhD, 7542073627, rxv331@miami.edu
About this study
Official title: Mechanisms and Utility of Multisensory Body- Representation in SCI and SCI-Related Neuropathic Pain
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.
- Conditions
- Spinal Cord Injuries, Neuropathic Pain
- Being tested
- tDCS and bodily illusions
- Medical subject headings
- Spinal Cord Injuries, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS and bodily illusionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| SCI with pain | Experimental | Participants will undergo 2-4 weeks of combined intervention including transcranial direct current stimulation (tDCS) and bodily illusions (10 sessions total). Receives: Other: tDCS and bodily illusions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, up to 4 weeks
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
Measured: Baseline, up to 4 weeks
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.
Measured: Baseline, up to 4 weeks
Secondary outcomes (3)
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.
Measured: Baseline, up to 4 weeks
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.
Measured: Baseline, up to 4 weeks
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).
Measured: Baseline, up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start17 Oct 2023
- Primary completion20 Oct 2027 (estimated)
- Study completion20 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Widerstrom-Noga, University of Miami
- Investigators
- Eva Widerstrom-Noga, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010251
- Sponsor's protocol ID
- 20230447
- Other IDs
- SC220073
- Status last verified
- Nov 2025
- First submitted
- 18 Aug 2023
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No