CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 132 enrolled
Drug / intervention
transcranial Direct Current Stimulation (tDCS): active (Soterix ©) +3 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02487966
NCT02487966N/AActive

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

Spaulding Rehabilitation Hospital·interventional·Posted Jul 2, 2015·Updated Sep 25, 2025

In Brief

A clinical study evaluating transcranial Direct Current Stimulation (tDCS): active (Soterix ©), Mirror Therapy: active, and 2 other interventions for Phantom Limb Pain and Amputation, Traumatic. Active but no longer recruiting, targeting 132 participants across 2 sites in 2 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil, United States

Timeline

N/AActive
201620172018201920202021202220232024202520262027
First PostedJul 2, 2015
Enrollment StartJul 1, 2015
Primary CompletionMar 27, 2020
Study CompletionDec 21, 2026
TodayJul 1, 2026
Enrollment to primary: 4.7 yearsPosted 11.0 years ago

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.

Mirror Therapy: activebehavioral

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.

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.

Mirror Therapy: Shambehavioral

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.