Predicting Pain Response to Transcranial Direct Current Stimulation for Phantom Limb Pain in Limb Amputees
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Phantom Limb Pain
- Sponsor
- Spaulding Rehabilitation Hospital
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Pain as Measured by the Visual Analog Scale
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Felipe Fregni, MD, PhD, MPH
Principal Investigator
Spaulding Rehabilitation Hospital
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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.