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

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

Interventions

DEVICE

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

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.

BEHAVIORAL

Mirror Therapy: active

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.

DEVICE

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

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.

BEHAVIORAL

Mirror Therapy: Sham

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.

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary

  collaborator OTHER

• Spaulding Rehabilitation Hospital

  lead OTHER

Principal Investigators

• Felipe Fregni, MD, PhD, MPH · Spaulding Rehabilitation Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-07-31

Primary Completion

2020-03-27

Completion

2026-12-21

Countries

• United States
• Brazil

Study Locations