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Optimizing Rehabilitation for Phantom Limb Pain Using Mirror Therapy and Transcranial Direct Current Stimulation (tDCS)

Primary Purpose

Phantom Limb Pain, Amputation, Traumatic

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
transcranial Direct Current Stimulation (tDCS): active (Soterix ©)
Mirror Therapy: active
transcranial Direct Current Stimulation (tDCS): sham (Soterix ©)
Mirror Therapy: Sham
Sponsored by
Spaulding Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Phantom Limb Pain focused on measuring tDCS, Mirror Therapy, Phantom Limb Pain, Traumatic amputation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Able to provide informed consent to participate in the study.
  2. Subject is older than 18 years.
  3. Unilateral lower limb amputation.
  4. Traumatic amputation greater than 1 year ago.
  5. Chronic PLP for at least 3 months previous to enrollment in the study, experienced regularly for at least once a week.
  6. Average pain of at least 4 on a numeric rating scale in the previous week (NRS; ranging from 0 to 10).
  7. 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 and transcranial magnetic stimulation

    • Ferromagnetic metal in the head (e.g., plates or pins, bullets, shrapnel)
    • Implanted neck or head electronic medical devices (e.g., cochlear implants, vagus nerve stimulator)
  4. History of chronic pain previous to the amputation.
  5. Head injury resulting in loss of consciousness for at least 30 min or pos-traumatic amnesia for greater than 24 hours, as self-reported
  6. Unstable medical conditions (e.g. uncontrolled diabetes, uncompensated cardiac issues, heart failure or chronic obstructive pulmonary disease).
  7. Uncontrolled Epilepsy or prior seizures within the last 1 year.
  8. Suffering from severe depression (as defined by a score of >30 in the Beck Depression Inventory).*
  9. History of unexplained fainting spells or loss of consciousness as self-reported during the last 2 years.
  10. History of neurosurgery, as self-reported.
  11. Mirror Therapy in the previous 3 months

Sites / Locations

  • Spaulding Rehabilitation Network Research Institute
  • IMREA HCFMUSP - Rede Lucy Montoro

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Sham Comparator

Arm Label

Active tDCS and Active Mirror Therapy

Active tDCS and sham Mirror Therapy

Sham tDCS and active Mirror Therapy

Sham tDCS and sham Mirrory Therapy

Arm Description

Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of active Mirror Therapy.

Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of sham Mirror Therapy.

Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of active Mirror Therapy.

Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of sham Mirror Therapy.

Outcomes

Primary Outcome Measures

Changes in the Visual Analog Scale for Phantom Limb Pain
The primary endpoint will be the severity of pain measured by changes in PLP from baseline to 4 weeks (value at 4 weeks minus value at baseline), as indexed by a Visual Analog Scale (VAS). The VAS pain scale is a simple 10- point scale (0 = ''no pain'', 10 = ''pain as bad as you can imagine''). Since we are using a difference, smaller values (negative) represent a better outcome.

Secondary Outcome Measures

Changes in the Visual Analog Scale for Stump Pain
The endpoint will be the severity of pain measured by changes in Stump Pain from baseline to 4 weeks (value at 4 weeks minus value at baseline), as indexed by a Visual Analog Scale (VAS). The VAS Phantom Limb Stump Pain scale is a simple 10- point scale (0 = ''no Phantom Limb Stump Pain'', 10 = ''Phantom Limb Stump Pain as bad as you can imagine''). Since we are using a difference, smaller values (negative) represent a better outcome.
Changes in the Visual Analog Scale for Phantom Limb Sensation
The endpoint will be the severity of pain measured by changes in Phantom Limb Sensation from baseline to 4 weeks (value at 4 weeks minus value at baseline), as indexed by a Visual Analog Scale (VAS). The VAS Phantom Limb Sensation scale is a simple 10- point scale (0 = ''no Phantom Limb Sensation'', 10 = ''Phantom Limb Sensation as much as you can imagine''). Since we are using a difference, smaller values (negative) represent a better outcome.

Full Information

First Posted
June 22, 2015
Last Updated
August 11, 2022
Sponsor
Spaulding Rehabilitation Hospital
Collaborators
Massachusetts Eye and Ear Infirmary
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1. Study Identification

Unique Protocol Identification Number
NCT02487966
Brief Title
Optimizing Rehabilitation for Phantom Limb Pain Using Mirror Therapy and Transcranial Direct Current Stimulation (tDCS)
Official Title
Optimizing Rehabilitation for Phantom Limb Pain Using Mirror Therapy and Transcranial Direct Current Stimulation (tDCS)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 2015 (undefined)
Primary Completion Date
March 27, 2020 (Actual)
Study Completion Date
December 21, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spaulding Rehabilitation Hospital
Collaborators
Massachusetts Eye and Ear Infirmary

4. Oversight

Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a two-site study that explores the effects of mirror therapy and transcranial Direct Current Stimulation (tDCS, Soterix ©) in a randomized factorial controlled trial in which patients will be assigned to one of four groups: active tDCS and active MT; sham tDCS and active MT; active tDCS and sham MT (which consists of using a covered mirror for the therapy); and both sham tDCS and sham MT (covered mirror).
Detailed Description
Phantom limb pain (PLP) belongs to a group of neuropathic pain syndromes that is characterized by pain in the amputated limb. Rehabilitation for chronic pain involves a structured treatment plan targeting all dimensions of the pain experience, and should include a comprehensive interdisciplinary approach that allows patients to receive the most benefit according to their needs. As in other chronic pain syndromes, chronic Phantom limb pain (PLP) is often difficult to treat; showing to be resistant to classical pharmacological and surgical treatment approaches. In this context, we hypothesize that novel treatments of PLP need to target specific neural networks associated with this maladaptive plasticity. Transcranial direct current stimulation (tDCS,Soterix ©) is a powerful and non-invasive technique of brain stimulation that is known to significantly modulate plasticity and alleviate chronic pain in various syndromes. device for this trial. This study usiGiven tDCS underlying neural mechanisms, it is critical to use a multimodal approach to treatment - using both tDCS and behavioral therapy simultaneously. In this case, an ideal therapy is mirror therapy (MT). Recently, we showed that anodal tDCS can induce a selective short-lasting relief from PLP, and repeated applications of anodal tDCS induces long-lasting analgesic effects. These preliminary results show that tDCS may be a promising rehabilitative tool for the management of chronic PLP. This neurorehabilitation technique is commonly used in PLP, and is designed to modulate cortical mechanisms of pain by performing movements using the unaffected limb in front of a mirror. We propose to carry out a mechanistic, factorial, randomized controlled trial to evaluate a novel rehabilitation approach combining tDCS and MT in PLP patients. We aim to compare the brain changes before and after treatment in order to study the mechanisms underlying PLP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phantom Limb Pain, Amputation, Traumatic
Keywords
tDCS, Mirror Therapy, Phantom Limb Pain, Traumatic amputation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS and Active Mirror Therapy
Arm Type
Experimental
Arm Description
Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of active Mirror Therapy.
Arm Title
Active tDCS and sham Mirror Therapy
Arm Type
Experimental
Arm Description
Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of sham Mirror Therapy.
Arm Title
Sham tDCS and active Mirror Therapy
Arm Type
Experimental
Arm Description
Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of active Mirror Therapy.
Arm Title
Sham tDCS and sham Mirrory Therapy
Arm Type
Sham Comparator
Arm Description
Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of sham Mirror Therapy.
Intervention Type
Device
Intervention Name(s)
transcranial Direct Current Stimulation (tDCS): active (Soterix ©)
Intervention Description
Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. For active tDCS, the subject will undergo stimulation for 20 minutes.
Intervention Type
Behavioral
Intervention Name(s)
Mirror Therapy: active
Intervention Description
Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist.
Intervention Type
Device
Intervention Name(s)
transcranial Direct Current Stimulation (tDCS): sham (Soterix ©)
Intervention Description
Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. The subject will undergo stimulation for 20 minutes. This is the same parameters as the active one, except the current will be ramped up and then down again (for 30 seconds total) to simulate the feeling of active stimulation.
Intervention Type
Behavioral
Intervention Name(s)
Mirror Therapy: Sham
Intervention Description
Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb, only the mirror will be covered. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist. We will use the same all of these techniques as active Mirror Therapy only the mirror will be covered during all activities.
Primary Outcome Measure Information:
Title
Changes in the Visual Analog Scale for Phantom Limb Pain
Description
The primary endpoint will be the severity of pain measured by changes in PLP from baseline to 4 weeks (value at 4 weeks minus value at baseline), as indexed by a Visual Analog Scale (VAS). The VAS pain scale is a simple 10- point scale (0 = ''no pain'', 10 = ''pain as bad as you can imagine''). Since we are using a difference, smaller values (negative) represent a better outcome.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Changes in the Visual Analog Scale for Stump Pain
Description
The endpoint will be the severity of pain measured by changes in Stump Pain from baseline to 4 weeks (value at 4 weeks minus value at baseline), as indexed by a Visual Analog Scale (VAS). The VAS Phantom Limb Stump Pain scale is a simple 10- point scale (0 = ''no Phantom Limb Stump Pain'', 10 = ''Phantom Limb Stump Pain as bad as you can imagine''). Since we are using a difference, smaller values (negative) represent a better outcome.
Time Frame
4 weeks
Title
Changes in the Visual Analog Scale for Phantom Limb Sensation
Description
The endpoint will be the severity of pain measured by changes in Phantom Limb Sensation from baseline to 4 weeks (value at 4 weeks minus value at baseline), as indexed by a Visual Analog Scale (VAS). The VAS Phantom Limb Sensation scale is a simple 10- point scale (0 = ''no Phantom Limb Sensation'', 10 = ''Phantom Limb Sensation as much as you can imagine''). Since we are using a difference, smaller values (negative) represent a better outcome.
Time Frame
4 weeks

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. Unilateral lower limb amputation. Traumatic amputation greater than 1 year ago. Chronic PLP for at least 3 months previous to enrollment in the study, experienced regularly for at least once a week. 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 and transcranial magnetic stimulation Ferromagnetic metal in the head (e.g., plates or pins, bullets, shrapnel) Implanted neck or head electronic medical devices (e.g., cochlear implants, vagus nerve stimulator) History of chronic pain previous to the amputation. 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 or prior seizures within the last 1 year. 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. Mirror Therapy in the previous 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felipe Fregni, MD, PhD, MPH
Organizational Affiliation
Spaulding Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spaulding Rehabilitation Network Research Institute
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Facility Name
IMREA HCFMUSP - Rede Lucy Montoro
City
São Paulo
ZIP/Postal Code
04116-030
Country
Brazil

12. IPD Sharing Statement

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Optimizing Rehabilitation for Phantom Limb Pain Using Mirror Therapy and Transcranial Direct Current Stimulation (tDCS)

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