Skip to main content
OpenTrials
Completed

NCT Number: NCT02627495

Predicting Pain Response to Transcranial Direct Current Stimulation for Phantom Limb Pain in Limb Amputees

This study explores the effects transcranial Direct Current Stimulation (tDCS, Soterix ©) on Phantom Limb Pain for patients experiencing chronic phantom limb pain in open-label study design.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Primary location

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02129, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Able to provide informed consent to participate in the study.
  • Subject is older than 18 years.
  • 3 months of phantom limb pain (experienced regularly for at least once a week) after the amputated limb has completely healed.
  • Average pain of at least 4 on a numeric rating scale in the previous week (NRS; ranging from 0 to 10).
  • If the subject is taking any medications, dosages must be stable for at least 2 weeks prior to the enrollment of the study.

Exclusion criteria

  • Pregnancy or trying to become pregnant in the next 2 months.
  • History of alcohol or drug abuse within the past 6 months as self-reported.
  • Presence of the following contraindication to transcranial direct current stimulation Ferromagnetic metal in the head (e.g., plates or pins, bullets, shrapnel) Implanted head electronic medical devices (e.g., cochlear implants)
  • Head injury resulting in loss of consciousness for at least 30 min or pos-traumatic amnesia for greater than 24 hours, as self-reported
  • Unstable medical conditions (e.g. uncontrolled diabetes, uncompensated cardiac issues, heart failure or chronic obstructive pulmonary disease).
  • Uncontrolled Epilepsy
  • Suffering from severe depression (as defined by a score of >30 in the Beck Depression Inventory).*
  • History of unexplained fainting spells or loss of consciousness as self-reported during the last 2 years.
  • History of neurosurgery, as self-reported.

Treatment and study plan

transcranial Direct Current Stimulation (tDCS): (Soterix ©)

Device

Subjects will undergo tDCS stimulation. We will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated limb (or for bilateral amputees contralateral to the most painful side). The subject will undergo stimulation for 20 minutes. The subject will have 5 sessions of stimulation during a 1 week time period.

Primary outcomes

  1. Pain as Measured by the Visual Analog Scale

    Time frame: Change in outcome from baseline to 2-week follow-up (after the last day of stimulation)

    The VAS is a common assessment used which asks subjects to self-reportedly measure their pain on a visual scale (i.e., unbearable to none). We will use a VAS to determine subjects' pain scores. Subjects will rate their pain from 0 - indicating no pain at all, to 10 - indicating the worst pain felt. This scale is also colored, from green (at 0) to red (at 10), as a visual indicator of pain.

Sponsors and collaborators

Lead sponsor

Spaulding Rehabilitation Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2021
First posted
Dec 11, 2015
Registry last updated
May 11, 2021

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.

Published trials that share one or more normalized conditions with this study.