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

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ClinicalTrials.gov Identifier: NCT02627495
Recruitment Status : Completed
First Posted : December 11, 2015
Results First Posted : April 23, 2021
Last Update Posted : May 11, 2021
Sponsor:
Information provided by (Responsible Party):
Felipe Fregni, MD, PhD, MPH, Spaulding Rehabilitation Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Phantom Limb Pain Device: transcranial Direct Current Stimulation (tDCS): (Soterix ©)

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Predicting Pain Response to Transcranial Direct Current Stimulation for Phantom Limb Pain in Limb Amputees
Actual Study Start Date : December 1, 2015
Actual Primary Completion Date : November 22, 2019
Actual Study Completion Date : March 9, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Limb Loss

Arms and Interventions
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Arm Intervention/treatment
Experimental: tDCS intervention (open label)
Subjects will undergo tDCS stimulation
 Device: transcranial Direct Current Stimulation (tDCS): (Soterix ©)
Subjects will undergo tDCS stimulation. We will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated limb (or for bilateral amputees contralateral to the most painful side). The subject will undergo stimulation for 20 minutes. The subject will have 5 sessions of stimulation during a 1 week time period.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02627495


Locations
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United States, Massachusetts
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States, 02129
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
  Study Documents (Full-Text)

Documents provided by Felipe Fregni, MD, PhD, MPH, Spaulding Rehabilitation Hospital:
Study Protocol and Statistical Analysis Plan  [PDF] June 6, 2017

More Information
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Responsible Party: Felipe Fregni, MD, PhD, MPH, Principal Investigator, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT02627495    
Other Study ID Numbers: 2015P002525
First Posted: December 11, 2015    Key Record Dates
Results First Posted: April 23, 2021
Last Update Posted: May 11, 2021
Last Verified: April 2021
Keywords provided by Felipe Fregni, MD, PhD, MPH, Spaulding Rehabilitation Hospital:
maladaptive plasticity
Limb amputation
phantom limb pain
tDCS
non-invasive brain stimulation
Additional relevant MeSH terms:
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Phantom Limb
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
 Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain