Back to resultsPredicting Pain Response to Transcranial Direct Current Stimulation for Phantom Limb Pain in Limb Amputees
Primary Purpose
Phantom Limb Pain
Status
Completed
Phase
Locations
United States
Study Type
Interventional
Intervention
transcranial Direct Current Stimulation (tDCS): (Soterix ©)
Sponsored by
About this trial
This is an interventional treatment trial for Phantom Limb Pain focused on measuring maladaptive plasticity, Limb amputation, phantom limb pain, tDCS, non-invasive brain stimulation
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.
Sites / Locations
- Spaulding Rehabilitation Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
tDCS intervention (open label)
Arm Description
Subjects will undergo tDCS stimulation
Outcomes
Primary Outcome Measures
Pain as Measured by the Visual Analog Scale
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
Full Information
NCT ID
NCT02627495
First Posted
November 16, 2015
Last Updated
April 22, 2021
Sponsor
Spaulding Rehabilitation Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02627495
Brief Title
Predicting Pain Response to Transcranial Direct Current Stimulation for Phantom Limb Pain in Limb Amputees
Official Title
Predicting Pain Response to Transcranial Direct Current Stimulation for Phantom Limb Pain in Limb Amputees
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2015 (Actual)
Primary Completion Date
November 22, 2019 (Actual)
Study Completion Date
March 9, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spaulding Rehabilitation Hospital
4. Oversight
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phantom Limb Pain
Keywords
maladaptive plasticity, Limb amputation, phantom limb pain, tDCS, non-invasive brain stimulation
7. Study Design
Primary Purpose
Treatment
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tDCS intervention (open label)
Arm Type
Experimental
Arm Description
Subjects will undergo tDCS stimulation
Intervention Type
Device
Intervention Name(s)
transcranial Direct Current Stimulation (tDCS): (Soterix ©)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain as Measured by the Visual Analog Scale
Description
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.
Time Frame
Change in outcome from baseline to 2-week follow-up (after the last day of stimulation)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Spaulding Rehabilitation Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Predicting Pain Response to Transcranial Direct Current Stimulation for Phantom Limb Pain in Limb Amputees
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