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Phantom Limb PainNCT02487966

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

A study testing transcranial Direct Current Stimulation (tDCS): active (Soterix ©) and Mirror Therapy: active in people with Phantom Limb Pain and Amputation, Traumatic, run by Spaulding Rehabilitation Hospital at 2 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Phantom Limb Pain, Amputation, Traumatic
What is being tested?
transcranial Direct Current Stimulation (tDCS): active (Soterix ©) and Mirror Therapy: active
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
132 participants
Where
2 sitesin 2 countries
Study dates
Jul 2015to 21 Dec 2026
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • Spaulding Rehabilitation Network Research Institute

    Charlestown, Massachusetts, 02129

Other trials in United States

Brazil1 site

  • IMREA HCFMUSP - Rede Lucy Montoro

    São Paulo, 04116-030

Other trials in Brazil

About this study

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).

Read the detailed description

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 underlying PLP.

Being tested
transcranial Direct Current Stimulation (tDCS): active (Soterix ©), Mirror Therapy: active, transcranial Direct Current Stimulation (tDCS): sham (Soterix ©), Mirror Therapy: Sham
Keywords
tDCS, Mirror Therapy, Phantom Limb Pain, Traumatic amputation
Medical subject headings
Phantom Limb, Amputation, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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: activeBehavioural

    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: ShamBehavioural

    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.

Study groups in NCT02487966
Study groupRoleWhat they receive
Active tDCS and Active Mirror TherapyExperimentalSubjects will receive 20 minutes of active tDCS, while receiving 15 minutes of active Mirror Therapy.
Receives: Device: transcranial Direct Current Stimulation (tDCS): active (Soterix ©); Behavioral: Mirror Therapy: active
Active tDCS and sham Mirror TherapyExperimentalSubjects will receive 20 minutes of active tDCS, while receiving 15 minutes of sham Mirror Therapy.
Receives: Device: transcranial Direct Current Stimulation (tDCS): active (Soterix ©); Behavioral: Mirror Therapy: Sham
Sham tDCS and active Mirror TherapyExperimentalSubjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of active Mirror Therapy.
Receives: Behavioral: Mirror Therapy: active; Device: transcranial Direct Current Stimulation (tDCS): sham (Soterix ©)
Sham tDCS and sham Mirrory TherapySham comparatorSubjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of sham Mirror Therapy.
Receives: Device: transcranial Direct Current Stimulation (tDCS): sham (Soterix ©); Behavioral: Mirror Therapy: Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4 weeks

Secondary outcomes (2)

  1. Changes in the Visual Analog Scale for Stump Pain

    The endpoint will be the severity of pain measured by changes in Stump Pain from baseline to 4 weeks (value at 4 weeks minus value at baseline), as indexed by a Visual Analog Scale (VAS). The VAS Phantom Limb Stump Pain scale is a simple 10- point scale (0 = ''no Phantom Limb Stump Pain'', 10 = ''Phantom Limb Stump Pain as bad as you can imagine''). Since we are using a difference, smaller values (negative) represent a better outcome.

    Measured: 4 weeks

  2. Changes in the Visual Analog Scale for Phantom Limb Sensation

    The endpoint will be the severity of pain measured by changes in Phantom Limb Sensation from baseline to 4 weeks (value at 4 weeks minus value at baseline), as indexed by a Visual Analog Scale (VAS). The VAS Phantom Limb Sensation scale is a simple 10- point scale (0 = ''no Phantom Limb Sensation'', 10 = ''Phantom Limb Sensation as much as you can imagine''). Since we are using a difference, smaller values (negative) represent a better outcome.

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2015 (estimated)
  2. Study startJul 2015
  3. Primary completion27 Mar 2020
  4. Study completion21 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
132 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02487966
Sponsor's protocol ID
2015P001065
Status last verified
Sep 2025
First submitted
22 Jun 2015
Last updated
25 Sep 2025
Data monitoring committee
No
FDA-regulated device
No

Publications

  • Flor H. Phantom-limb pain: characteristics, causes, and treatment. Lancet Neurol. 2002 Jul;1(3):182-9. doi: 10.1016/s1474-4422(02)00074-1.

    PubMed 12849487

  • Nikolajsen L, Staehelin Jensen T. Phantom limb pain. Curr Rev Pain. 2000;4(2):166-70. doi: 10.1007/s11916-000-0052-0.

    PubMed 10998730

  • Manchikanti L, Singh V. Managing phantom pain. Pain Physician. 2004 Jul;7(3):365-75.

    PubMed 16858476

  • Birbaumer N, Lutzenberger W, Montoya P, Larbig W, Unertl K, Topfner S, Grodd W, Taub E, Flor H. Effects of regional anesthesia on phantom limb pain are mirrored in changes in cortical reorganization. J Neurosci. 1997 Jul 15;17(14):5503-8. doi: 10.1523/JNEUROSCI.17-14-05503.1997.

    PubMed 9204932

  • Borsook D, Becerra L, Fishman S, Edwards A, Jennings CL, Stojanovic M, Papinicolas L, Ramachandran VS, Gonzalez RG, Breiter H. Acute plasticity in the human somatosensory cortex following amputation. Neuroreport. 1998 Apr 20;9(6):1013-7. doi: 10.1097/00001756-199804200-00011.

    PubMed 9601659

  • Flor H, Elbert T, Knecht S, Wienbruch C, Pantev C, Birbaumer N, Larbig W, Taub E. Phantom-limb pain as a perceptual correlate of cortical reorganization following arm amputation. Nature. 1995 Jun 8;375(6531):482-4. doi: 10.1038/375482a0.

    PubMed 7777055

  • Grusser SM, Winter C, Muhlnickel W, Denke C, Karl A, Villringer K, Flor H. The relationship of perceptual phenomena and cortical reorganization in upper extremity amputees. Neuroscience. 2001;102(2):263-72. doi: 10.1016/s0306-4522(00)00491-7.

    PubMed 11166112

  • Montoya P, Ritter K, Huse E, Larbig W, Braun C, Topfner S, Lutzenberger W, Grodd W, Flor H, Birbaumer N. The cortical somatotopic map and phantom phenomena in subjects with congenital limb atrophy and traumatic amputees with phantom limb pain. Eur J Neurosci. 1998 Mar;10(3):1095-102. doi: 10.1046/j.1460-9568.1998.00122.x.

    PubMed 9753177

  • Ramachandran VS, Rogers-Ramachandran D, Stewart M. Perceptual correlates of massive cortical reorganization. Science. 1992 Nov 13;258(5085):1159-60. doi: 10.1126/science.1439826. No abstract available.

    PubMed 1439826

  • Davis KD, Kwan CL, Crawley AP, Mikulis DJ. Event-related fMRI of pain: entering a new era in imaging pain. Neuroreport. 1998 Sep 14;9(13):3019-23. doi: 10.1097/00001756-199809140-00018.

    PubMed 9804308

  • Foell J, Bekrater-Bodmann R, Diers M, Flor H. Mirror therapy for phantom limb pain: brain changes and the role of body representation. Eur J Pain. 2014 May;18(5):729-39. doi: 10.1002/j.1532-2149.2013.00433.x. Epub 2013 Dec 10.

    PubMed 24327313

  • Lotze M, Flor H, Grodd W, Larbig W, Birbaumer N. Phantom movements and pain. An fMRI study in upper limb amputees. Brain. 2001 Nov;124(Pt 11):2268-77. doi: 10.1093/brain/124.11.2268.

    PubMed 11673327

  • Gandiga PC, Hummel FC, Cohen LG. Transcranial DC stimulation (tDCS): a tool for double-blind sham-controlled clinical studies in brain stimulation. Clin Neurophysiol. 2006 Apr;117(4):845-50. doi: 10.1016/j.clinph.2005.12.003. Epub 2006 Jan 19.

    PubMed 16427357

  • Bolognini N, Olgiati E, Maravita A, Ferraro F, Fregni F. Motor and parietal cortex stimulation for phantom limb pain and sensations. Pain. 2013 Aug;154(8):1274-80. doi: 10.1016/j.pain.2013.03.040. Epub 2013 Apr 19.

    PubMed 23707312

  • Bolognini N, Spandri V, Olgiati E, Fregni F, Ferraro F, Maravita A. Long-term analgesic effects of transcranial direct current stimulation of the motor cortex on phantom limb and stump pain: a case report. J Pain Symptom Manage. 2013 Oct;46(4):e1-4. doi: 10.1016/j.jpainsymman.2013.06.014. Epub 2013 Aug 7. No abstract available.

    PubMed 23932177

Questions about this trial

What is this clinical trial studying?

A study testing transcranial Direct Current Stimulation (tDCS): active (Soterix ©) and Mirror Therapy: active in people with Phantom Limb Pain and Amputation, Traumatic, run by Spaulding Rehabilitation Hospital at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in the Visual Analog Scale for Phantom Limb Pain (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02487966, which also lists 75 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025; AzTrials last refreshed its copy on 30 Oct 2026.

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