Effects of Bodily Illusion and tDCS on SCI-related Neuropathic Pain
1 other identifier
interventional
8
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 2, 2020
CompletedFirst Posted
Study publicly available on registry
October 8, 2020
CompletedStudy Start
First participant enrolled
January 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2023
CompletedResults Posted
Study results publicly available
March 19, 2024
CompletedMarch 19, 2024
February 1, 2024
2.2 years
October 2, 2020
January 22, 2024
February 21, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Change in Neuropathic Pain Severity
Assessed by the use of the Neuropathic Pain Symptom Inventory (NPSI). The NPSI has a total score ranging from 0 to 100 with the higher score indicating greater pain.
baseline, up to two weeks
Change in Performance of Body Part Processing
Assessed by a customized computer task, where individual reaction times will be measured in response to mental rotation of body parts. Results will be reported in milliseconds.
baseline, up to two weeks
Secondary Outcomes (1)
Change in Sensory Thresholds
baseline, up to two weeks
Study Arms (2)
BI-TDCS Stimulation Group
EXPERIMENTALParticipants in this group will receive the BI and TDCS interventions for 10 sessions over two weeks.
BI-TDCS (Sham) Stimulation Group
SHAM COMPARATORParticipants in this group will receive the BI and TDCS (Sham) interventions for 10 sessions over two weeks.
Interventions
Each sessions will consists of two types of illusions that are 15 min each, the rubber hand illusion (RHI) and the walking illusion (WI) that involve both arms and legs.
Each sessions will consists of electrical current delivered from a battery-driven, constant current stimulator using saline-soaked surface sponge electrodes. One electrode will be placed on your scalp on the right side and the other electrode over the left eye on your forehead. A weak current will be applied for 30 min at the same time as the BI.
Each session of the Sham tDCS will be applied for 30 min at the same time as the BI.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Miamilead
- Floridacollaborator
Study Sites (1)
University of Miami
Miami, Florida, 33136, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Eva Widerstrom-Noga, PhD; Roberta Vastano, PhD
- Organization
- University of Miami
Study Officials
- PRINCIPAL INVESTIGATOR
Eva Widerstrom-Noga, Phd
University of Miami
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Professor
Study Record Dates
First Submitted
October 2, 2020
First Posted
October 8, 2020
Study Start
January 13, 2021
Primary Completion
March 10, 2023
Study Completion
March 10, 2023
Last Updated
March 19, 2024
Results First Posted
March 19, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share