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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 : Recruiting
First Posted : December 11, 2015
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Felipe Fregni, 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 Phase
Phantom Limb Pain Device: transcranial Direct Current Stimulation (tDCS): (Soterix ©) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Study Start Date : December 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

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) ]

Secondary Outcome Measures :
  1. depression level as measured by the Beck depression inventory [ Time Frame: post-treatment (~1-2 weeks after baseline); 2-week follow-up (after the last day of stimulation) ]
  2. stump pain as measured by the "Visual Analog Scale for stump pain" [ Time Frame: baseline; post-treatment (~1-2 weeks after baseline); 2-week follow-up (after the last day of stimulation) ]
  3. phantom limb sensations as measured by the "Visual Analog Scale for phantom limb sensation" [ Time Frame: baseline; post-treatment (~1-2 weeks after baseline); 2-week follow-up (after the last day of stimulation) ]
  4. phantom limb telescopy as measured by the "Visual Analog Scale for phantom limb telescopy" [ Time Frame: baseline; post-treatment (~1-2 weeks after baseline); 2-week follow-up (after the last day of stimulation) ]
  5. anxiety as measured by the "Beck Anxiety Inventory" [ Time Frame: baseline; post-treatment (~1-2 weeks after baseline); 2-week follow-up (after the last day of stimulation) ]
  6. safety as measured by "Stroop Test" [ Time Frame: baseline; post-treatment (~1-2 weeks after baseline) ]
  7. Quality of Life as measured by the "Health Survey SF-36" [ Time Frame: baseline; 2-week follow-up up (after the last day of stimulation) ]
  8. Subjective Treatment Effectiveness measure (by the subject) as measured by the "Global Impression of Change scale" [ Time Frame: post-treatment (~1-2 weeks after baseline) ]

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


Contacts
Contact: Felipe Fregni, MD, PhD, MPH 617-573-2326 ffregni@partners.org
Contact: Melanie French, B.S. 617-952-6151 mnfrench@partners.org

Locations
United States, Massachusetts
Spaulding Rehabilitation Hospital Recruiting
Boston, Massachusetts, United States, 02129
Contact: Felipe Fregni, MD    617-573-2195      
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Investigators
Principal Investigator: Felipe Fregni, MD, PhD, MPH Spaulding Rehabilitation Hospital
More Information
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Responsible Party: Felipe Fregni, Principal Investigator, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT02627495     History of Changes
Other Study ID Numbers: 2015P002525
First Posted: December 11, 2015    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018

Keywords provided by Felipe Fregni, Spaulding Rehabilitation Hospital:
maladaptive plasticity
Limb amputation
phantom limb pain
tDCS
non-invasive brain stimulation

Additional relevant MeSH terms:
Phantom Limb
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
 Pain, Postoperative
Pain
Postoperative Complications
Pathologic Processes
Signs and Symptoms