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

Running, not enrolling · Not applicable · Has a placebo group

Conditions studied: Phantom Limb Pain, Amputation, Traumatic

In brief

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).

Key facts

Study ID

NCT02487966

Run by

Spaulding Rehabilitation Hospital

People needed

132

Starts

2015-07-01

Expected to finish

2026-12-21

Last updated by the study team

2025-09-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Spaulding Rehabilitation Network Research Institute — Charlestown, Massachusetts, United States
• IMREA HCFMUSP - Rede Lucy Montoro — São Paulo, Brazil

Full record on ClinicalTrials.gov

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