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NCT Number: NCT06010251

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

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuropathic Pain Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Eva Widerstrom-Noga, PhD

CONTACT

[email protected]

305-243-7125

Eva Widerstrom-Noga, PhD

PRINCIPAL_INVESTIGATOR

Roberta Vastano, PhD

CONTACT

[email protected]

7542073627

Roberta Vastano, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Inclusion criteria

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.

Exclusion criteria

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
  • 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

Treatment and study plan

tDCS and bodily illusions

Other

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.

Primary outcomes

  1. 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.

  2. 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

  3. 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.

Secondary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

  3. Change in Global impression of changes by PGIC questionnaire

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Eva Widerstrom-Noga, PhD

CONTACT

[email protected]

(305)243-7125

Roberta Vastano, PhD

CONTACT

[email protected]

754 207 3627

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

Mechanisms and Utility of Multisensory Body- Representation in SCI and SCI-Related Neuropathic Pain

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 24, 2023
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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