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

Completed
Conditions
Phantom Limb Pain
Registration Number
NCT02627495
Lead Sponsor
Spaulding Rehabilitation Hospital
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
9
Inclusion Criteria
  1. Able to provide informed consent to participate in the study.
  2. Subject is older than 18 years.
  3. 3 months of phantom limb pain (experienced regularly for at least once a week) after the amputated limb has completely healed.
  4. Average pain of at least 4 on a numeric rating scale in the previous week (NRS; ranging from 0 to 10).
  5. 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
  1. Pregnancy or trying to become pregnant in the next 2 months.
  2. History of alcohol or drug abuse within the past 6 months as self-reported.
  3. 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)
  4. Head injury resulting in loss of consciousness for at least 30 min or pos-traumatic amnesia for greater than 24 hours, as self-reported
  5. Unstable medical conditions (e.g. uncontrolled diabetes, uncompensated cardiac issues, heart failure or chronic obstructive pulmonary disease).
  6. Uncontrolled Epilepsy
  7. Suffering from severe depression (as defined by a score of >30 in the Beck Depression Inventory).*
  8. History of unexplained fainting spells or loss of consciousness as self-reported during the last 2 years.
  9. History of neurosurgery, as self-reported.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Pain as Measured by the Visual Analog ScaleChange 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Spaulding Rehabilitation Hospital

🇺🇸

Boston, Massachusetts, United States

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