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Effects of Bodily Illusion and tDCS on SCI-related Neuropathic Pain

Primary Purpose

Neuropathic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bodily Illusions (BI) Procedure
Transcranial direct electrical stimulation (tDCS)
Sham Transcranial Direct Electrical Stimulation (tDCS)
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Neuropathic Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Participants will be men or women, 18-70 years of age, with an incomplete cervical traumatic SCI.
  2. 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).
  3. Participants must be willing and able to sign informed consent

Exclusion Criteria:

  1. Major psychiatric disease/disorder (self-reported)
  2. A significant neurological trauma besides SCI
  3. A recent (one-year) history of alcohol or drug abuse (selfreported)
  4. Any other medical conditions in which transcranial DCS is relatively contraindicated, such as pregnancy, epilepsy and/or seizures

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

BI-TDCS Stimulation Group

BI-TDCS (Sham) Stimulation Group

Arm Description

Participants in this group will receive the BI and TDCS interventions for 10 sessions over two weeks.

Participants in this group will receive the BI and TDCS (Sham) interventions for 10 sessions over two weeks.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Change in sensory thresholds
Assessed by the Quantitative Sensory Testing. Pain thresholds will be assessed using a numeric rating of 0 (No pain) to 10 (worse pain imaginable).

Full Information

First Posted
October 2, 2020
Last Updated
October 4, 2023
Sponsor
University of Miami
Collaborators
Florida
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1. Study Identification

Unique Protocol Identification Number
NCT04578574
Brief Title
Effects of Bodily Illusion and tDCS on SCI-related Neuropathic Pain
Official Title
Effects of Bodily Illusion and tDCS on Spinal Cord Injury (SCI) Related Neuropathic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 13, 2021 (Actual)
Primary Completion Date
March 10, 2023 (Actual)
Study Completion Date
March 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BI-TDCS Stimulation Group
Arm Type
Experimental
Arm Description
Participants in this group will receive the BI and TDCS interventions for 10 sessions over two weeks.
Arm Title
BI-TDCS (Sham) Stimulation Group
Arm Type
Sham Comparator
Arm Description
Participants in this group will receive the BI and TDCS (Sham) interventions for 10 sessions over two weeks.
Intervention Type
Other
Intervention Name(s)
Bodily Illusions (BI) Procedure
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial direct electrical stimulation (tDCS)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham Transcranial Direct Electrical Stimulation (tDCS)
Intervention Description
Each session of the Sham tDCS will be applied for 30 min at the same time as the BI.
Primary Outcome Measure Information:
Title
Change in neuropathic pain severity
Description
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.
Time Frame
baseline, up to two weeks
Title
Change in performance of body part processing
Description
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.
Time Frame
baseline, up to two weeks
Secondary Outcome Measure Information:
Title
Change in sensory thresholds
Description
Assessed by the Quantitative Sensory Testing. Pain thresholds will be assessed using a numeric rating of 0 (No pain) to 10 (worse pain imaginable).
Time Frame
baseline, up to two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Widerstrom-Noga, Phd
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Bodily Illusion and tDCS on SCI-related Neuropathic Pain

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