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

October 31, 2023 updated by: Eva Widerstrom-Noga, University of Miami

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Principal Investigator:
          • Eva Widerstrom-Noga, PhD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Roberta Vastano, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, up to 4 weeks
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
Baseline, up to 4 weeks
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.
Baseline, up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, up to 4 weeks
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.
Baseline, up to 4 weeks
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).
Baseline, up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Investigators

  • Principal Investigator: Eva Widerstrom-Noga, Phd, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2023

Primary Completion (Estimated)

October 20, 2026

Study Completion (Estimated)

October 20, 2026

Study Registration Dates

First Submitted

August 18, 2023

First Submitted That Met QC Criteria

August 18, 2023

First Posted (Actual)

August 24, 2023

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20230447

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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