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N/A N=9 Treatment

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

Phantom Limb Pain

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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