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

Neuropathic Pain Clinical Trial

Official title:

Effects of Bodily Illusion and tDCS on Spinal Cord Injury (SCI) Related Neuropathic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04578574
• Other study ID #: 20200841
• Status: Completed
• Phase: N/A
• Start date: January 13, 2021
• Est. completion date: March 10, 2023

Study information

• Verified date: February 2024
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 10, 2023
• Est. primary completion date: March 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Other:
• Bodily Illusions (BI) Procedure
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.

Device:
• Transcranial direct electrical stimulation (tDCS)
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.

Other:
• Sham Transcranial Direct Electrical Stimulation (tDCS)
Each session of the Sham tDCS will be applied for 30 min at the same time as the BI.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in Sensory Thresholds	Assessed by the Quantitative Sensory Testing. Pain thresholds are evaluated using Medoc machine (Medoc Ltd,Ramat Yishai, Israel and FDA approved. It assesses participants' ability to feel change in temperature (0°C to 50°C). The temperatures in this range may be felt as cool, cold, warm, and hot. A probe is placed on the skin and it feels either cool, cold, warm or hot. Participants' thresholds are recorded for cool or warm sensation, and for cold or hot painful thresholds.	baseline, up to two weeks