This study 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).
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
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.
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
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
Felipe Fregni, MD, PhD, MPH
Spaulding Rehabilitation Hospital
Felipe Fregni, MD, PhD, MPH