N/A
N=8
Effects of Bodily Illusion and tDCS on SCI-related Neuropathic Pain
Neuropathic Pain
Bottom Line
View on ClinicalTrials.gov: NCT04578574 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Change in Neuropathic Pain Severity — -7.3; 8.5 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bodily Illusions (BI) Procedure (Other); Transcranial direct electrical stimulation (tDCS) (Device); Sham Transcranial Direct Electrical Stimulation (tDCS) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Neuropathic Pain Severity |
-7.3; 8.5 | — |
| PRIMARY Change in Performance of Body Part Processing |
-18.2; 30.9; -4.5; 4.4 | — |
| SECONDARY Change in Sensory Thresholds |
2.2; -1.3; -1.37; 3.9 | — |
Summary
The purpose of this study is to evaluate the effect of a combination of two procedures: (1) Bodily Illusion (BI) and (2) Transcranial direct electrical stimulation (tDCS) on neuropathic pain.
Eligibility Criteria
Inclusion Criteria
- Participants will be men or women, 18-70 years of age, with an incomplete cervical traumatic SCI.
- Participants must have experienced neuropathic pain for a minimum of six months. They must have neuropathic pain in the moderate to severe category, which will be defined as a score of at least 4 on a Numeric Rating Scale (NRS); (range of 0 to 10).
- Participants must be willing and able to sign informed consent
Exclusion Criteria
- Major psychiatric disease/disorder (self-reported)
- A significant neurological trauma besides SCI
- A recent (one-year) history of alcohol or drug abuse (selfreported)
- Any other medical conditions in which transcranial DCS is relatively contraindicated, such as pregnancy, epilepsy and/or seizures
Data sourced from ClinicalTrials.gov (NCT04578574). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.