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

NCT06010251 | Recruiting

• 2 other identifiers: 20230447SC220073
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Neuropathic Pain

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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.

  Baseline, up to 4 weeks

Secondary Outcomes (3)

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

  Baseline, up to 4 weeks

• 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

Study Arms (1)

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).

Other: tDCS and bodily illusions

Interventions

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.

SCI with pain

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• SCI with Pain:
• Men or women
• fluent in English
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Neuralgia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Eva Widerstrom-Noga, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Widerstrom-Noga, PhD

CONTACT

(305)243-7125; ewiderstrom-noga@med.miami.edu

Roberta Vastano, PhD

CONTACT

754 207 3627; rxv331@miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: August 24, 2023
• Study Start: October 17, 2023
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): October 20, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)