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

NCT02487966 | Active Not Recruiting Results

• 1 other identifier: 2015P001065
• Study Type: interventional
• Target: 132
• Locations: 2 countries
• Sites: 2

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).

Conditions

Phantom Limb Pain; Amputation, Traumatic

Keywords

tDCS; Mirror Therapy; Phantom Limb Pain; Traumatic amputation

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks

Secondary Outcomes (2)

• Changes in the Visual Analog Scale for Stump Pain

  4 weeks

• Changes in the Visual Analog Scale for Phantom Limb Sensation

  4 weeks

Study Arms (4)

Active tDCS and Active Mirror Therapy

EXPERIMENTAL

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

Device: transcranial Direct Current Stimulation (tDCS): active (Soterix ©); Behavioral: Mirror Therapy: active

Active tDCS and sham Mirror Therapy

EXPERIMENTAL

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

Device: transcranial Direct Current Stimulation (tDCS): active (Soterix ©); Behavioral: Mirror Therapy: Sham

Sham tDCS and active Mirror Therapy

EXPERIMENTAL

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

Behavioral: Mirror Therapy: active; Device: transcranial Direct Current Stimulation (tDCS): sham (Soterix ©)

Sham tDCS and sham Mirrory Therapy

SHAM COMPARATOR

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

Device: transcranial Direct Current Stimulation (tDCS): sham (Soterix ©); Behavioral: Mirror Therapy: Sham

Interventions

transcranial Direct Current Stimulation (tDCS): active (Soterix ©) DEVICE

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.

Active tDCS and Active Mirror Therapy; Active tDCS and sham Mirror Therapy

Mirror Therapy: active BEHAVIORAL

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.

Active tDCS and Active Mirror Therapy; Sham tDCS and active Mirror Therapy

transcranial Direct Current Stimulation (tDCS): sham (Soterix ©) DEVICE

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.

Sham tDCS and active Mirror Therapy; Sham tDCS and sham Mirrory Therapy

Mirror Therapy: Sham BEHAVIORAL

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.

Active tDCS and sham Mirror Therapy; Sham tDCS and sham Mirrory Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead
• Massachusetts Eye and Ear Infirmary: collaborator

Study Sites (2)

Spaulding Rehabilitation Network Research Institute

Charlestown, Massachusetts, 02129, United States

Location

IMREA HCFMUSP - Rede Lucy Montoro

São Paulo, 04116-030, Brazil

Location

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• Nitsche MA, Cohen LG, Wassermann EM, Priori A, Lang N, Antal A, Paulus W, Hummel F, Boggio PS, Fregni F, Pascual-Leone A. Transcranial direct current stimulation: State of the art 2008. Brain Stimul. 2008 Jul;1(3):206-23. doi: 10.1016/j.brs.2008.06.004. Epub 2008 Jul 1.

  PMID: 20633386 BACKGROUND

• Nitsche MA, Jaussi W, Liebetanz D, Lang N, Tergau F, Paulus W. Consolidation of human motor cortical neuroplasticity by D-cycloserine. Neuropsychopharmacology. 2004 Aug;29(8):1573-8. doi: 10.1038/sj.npp.1300517.

  PMID: 15199378 BACKGROUND

• Schley MT, Wilms P, Toepfner S, Schaller HP, Schmelz M, Konrad CJ, Birbaumer N. Painful and nonpainful phantom and stump sensations in acute traumatic amputees. J Trauma. 2008 Oct;65(4):858-64. doi: 10.1097/TA.0b013e31812eed9e.

  PMID: 18849803 BACKGROUND

• Fregni F, Gimenes R, Valle AC, Ferreira MJ, Rocha RR, Natalle L, Bravo R, Rigonatti SP, Freedman SD, Nitsche MA, Pascual-Leone A, Boggio PS. A randomized, sham-controlled, proof of principle study of transcranial direct current stimulation for the treatment of pain in fibromyalgia. Arthritis Rheum. 2006 Dec;54(12):3988-98. doi: 10.1002/art.22195.

  PMID: 17133529 BACKGROUND

• CREUTZFELDT OD, FROMM GH, KAPP H. Influence of transcortical d-c currents on cortical neuronal activity. Exp Neurol. 1962 Jun;5:436-52. doi: 10.1016/0014-4886(62)90056-0. No abstract available.

  PMID: 13882165 BACKGROUND

• Wassermann EM. Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation, June 5-7, 1996. Electroencephalogr Clin Neurophysiol. 1998 Jan;108(1):1-16. doi: 10.1016/s0168-5597(97)00096-8.

  PMID: 9474057 BACKGROUND

• Pinto CB, Saleh Velez FG, Bolognini N, Crandell D, Merabet LB, Fregni F. Optimizing Rehabilitation for Phantom Limb Pain Using Mirror Therapy and Transcranial Direct Current Stimulation: A Randomized, Double-Blind Clinical Trial Study Protocol. JMIR Res Protoc. 2016 Jul 6;5(3):e138. doi: 10.2196/resprot.5645.

  PMID: 27383993 DERIVED

MeSH Terms

Conditions

Phantom Limb; Amputation, Traumatic

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Dr. Felipe Fregni
• Organization: Spaulding Rehabilitation Hospital

fregni.felipe@mgh.harvard.edu

6179526158

Study Officials

• Felipe Fregni, MD, PhD, MPH

  Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 22, 2015
• First Posted: July 2, 2015
• Study Start: July 1, 2015
• Primary Completion: March 27, 2020
• Study Completion (Estimated): December 21, 2026
• Last Updated: September 25, 2025
• Results First Posted: June 21, 2021

Record last verified: 2025-09

Locations

US (1); BR (1)