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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06010251
• Other study ID #: 20230447
• Status: Recruiting
• Phase: N/A
• Start date: October 17, 2023
• Est. completion date: October 20, 2026

Study information

• Verified date: October 2023
• Source: University of Miami
• Contact: Eva Widerstrom-Noga, PhD
• Phone: (305)243-7125
• Email: ewiderstrom-noga[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 20, 2026
• Est. primary completion date: October 20, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain
• Spinal Cord Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.	Baseline, up to 4 weeks
Secondary	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.	Baseline, up to 4 weeks
Secondary	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).	Baseline, up to 4 weeks