Utility of Multisensory Body-Representation in Spinal Cord Injury (SCI) With Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: tDCS and bodily illusions.
- Who it may be relevant to
- Registry conditions: Spinal Cord Injuries, Neuropathic Pain. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Mechanisms and Utility of Multisensory Body- Representation in SCI and SCI-Related Neuropathic Pain
Overview
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.
Interventions
- 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.
Primary outcome measures
- Change in neuropathic pain severity assessed by Neuropathic Pain Symptom Inventory (NPSI) [Time frame: Baseline, up to 4 weeks]
- Change in neuropathic pain interference assessed by pain interference questionnaire. [Time frame: Baseline, up to 4 weeks]
- Changes associated with sensory function/dysfunction assessed by quantitative sensory testing [Time frame: Baseline, up to 4 weeks]
Secondary outcome measures (3)
- Change in manageable pain assessed by days of manageable pain questionnaire. [Time frame: Baseline, up to 4 weeks]
- Changes of psychosocial assessed by Multidimensional Pain Inventory (pain severity subscale) [Time frame: Baseline, up to 4 weeks]
- Change in Global impression of changes by PGIC questionnaire [Time frame: Baseline, up to 4 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Miami — Miami
Identifiers
NCT: NCT06010251 · 20230447 · SC220073