N/A
N=9
Predicting Pain Response to Transcranial Direct Current Stimulation for Phantom Limb Pain in Limb Amputees
Phantom Limb Pain
Bottom Line
View on ClinicalTrials.gov: NCT02627495 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Pain as Measured by the Visual Analog Scale — -1.4 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- transcranial Direct Current Stimulation (tDCS): (Soterix ©) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Spaulding Rehabilitation Hospital
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain as Measured by the Visual Analog Scale |
-1.4 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02627495). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.