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Completed

NCT Number: NCT04578574

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

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.

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Key information

Conditions

Neuropathic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bodily Illusions (BI) Procedure

Other

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.

Transcranial direct electrical stimulation (tDCS)

Device

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.

Sham Transcranial Direct Electrical Stimulation (tDCS)

Other

Each session of the Sham tDCS will be applied for 30 min at the same time as the BI.

Primary outcomes

  1. Change in Neuropathic Pain Severity

    Time frame: baseline, up to two weeks

    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.

  2. Change in Performance of Body Part Processing

    Time frame: baseline, up to two weeks

    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 outcomes

  1. Change in Sensory Thresholds

    Time frame: baseline, up to two weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Florida

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 8, 2020
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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