Predicting Pain Response to Transcranial Direct Current Stimulation for Phantom Limb Pain in Limb Amputees
- 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
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Pain as Measured by the Visual Analog Scale 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Spaulding Rehabilitation Hospital
🇺🇸Boston, Massachusetts, United States