An interventional study of transcranial Direct Current Stimulation (tDCS): active (Soterix ©) and Mirror Therapy: active in Phantom Limb Pain and Amputation, Traumatic, sponsored by Spaulding Rehabilitation Hospital. Active, not recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-25.
Sponsored by Spaulding Rehabilitation Hospital · Not applicable, Interventional, and Treatment
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).
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.
163 studies on the registry are indexed under Phantom Limb; 35 are open to participants now.
This study's enrollment of 132 is above the median of 30 across 125 interventional studies indexed under Phantom Limb.
Browse Phantom Limb studies →Spaulding Rehabilitation Hospital is the lead sponsor of 117 studies on the registry; 27 are open to participants now.
Of its 20 completed or terminated interventional studies of FDA-regulated products, 17 (85%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Presence of the following to transcranial direct current stimulation and transcranial magnetic stimulation
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of active Mirror Therapy.
Device: transcranial Direct Current Stimulation (tDCS): active (Soterix ©) · Behavioral: Mirror Therapy: active
Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of sham Mirror Therapy.
Device: transcranial Direct Current Stimulation (tDCS): active (Soterix ©) · Behavioral: Mirror Therapy: Sham
Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of active Mirror Therapy.
Behavioral: Mirror Therapy: active · Device: transcranial Direct Current Stimulation (tDCS): sham (Soterix ©)
Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of sham Mirror Therapy.
Device: transcranial Direct Current Stimulation (tDCS): sham (Soterix ©) · Behavioral: Mirror Therapy: Sham
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.
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.
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.
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.
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.
Time frame: 4 weeks
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.
Time frame: 4 weeks
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.
Time frame: 4 weeks
| Milestone | Active tDCS and Active Mirror Therapy | Active tDCS and Sham Mirror Therapy | Sham tDCS and Active Mirror Therapy | Sham tDCS and Sham Mirrory Therapy |
|---|---|---|---|---|
| Started | 29 | 28 | 28 | 27 |
| Completed | 28 | 24 | 26 | 25 |
| Not completed | 1 | 4 | 2 | 2 |
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.
| units on a scale | Active tDCS and Active Mirror Therapy | Active tDCS and Sham Mirror Therapy | Sham tDCS and Active Mirror Therapy | Sham tDCS and Sham Mirrory Therapy |
|---|---|---|---|---|
| Changes in the Visual Analog Scale for Phantom Limb Pain | -2.84 ± 2.95 | -3.35 ± 3.24 | -1.78 ± 2.96 | -2.58 ± 2.78 |
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.
| units on a scale | Active tDCS and Active Mirror Therapy | Active tDCS and Sham Mirror Therapy | Sham tDCS and Active Mirror Therapy | Sham tDCS and Sham Mirrory Therapy |
|---|---|---|---|---|
| Changes in the Visual Analog Scale for Stump Pain | -1.31 ± 2.99 | -1.9 ± 3.99 | -0.91 ± 2.94 | -0.96 ± 2.84 |
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.
| units on a scale | Active tDCS and Active Mirror Therapy | Active tDCS and Sham Mirror Therapy | Sham tDCS and Active Mirror Therapy | Sham tDCS and Sham Mirrory Therapy |
|---|---|---|---|---|
| Changes in the Visual Analog Scale for Phantom Limb Sensation | -1.86 ± 2.55 | -2.55 ± 2.64 | -1.35 ± 2.64 | -2.83 ± 3.87 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active tDCS and Active Mirror Therapy | 0/29 (0%) | 0/29 (0%) | 7/29 (24.1%) |
| Active tDCS and Sham Mirror Therapy | 0/28 (0%) | 0/28 (0%) | 6/28 (21.4%) |
| Sham tDCS and Active Mirror Therapy | 0/28 (0%) | 0/28 (0%) | 6/28 (21.4%) |
| Sham tDCS and Sham Mirrory Therapy | 0/27 (0%) | 0/27 (0%) | 6/27 (22.2%) |
| Event | Active tDCS and Active Mirror Therapy | Active tDCS and Sham Mirror Therapy | Sham tDCS and Active Mirror Therapy | Sham tDCS and Sham Mirrory Therapy |
|---|---|---|---|---|
| Tingling sensation over stimulation areaSkin and subcutaneous tissue disorders | 7/29 | 6/28 | 6/28 | 6/27 |
| Age, Continuous(years) | Active tDCS and Active Mirror Therapy | Active tDCS and Sham Mirror Therapy | Sham tDCS and Active Mirror Therapy | Sham tDCS and Sham Mirrory Therapy | Total |
|---|---|---|---|---|---|
| Mean | 48.24 ± 16.28 | 39.96 ± 15.96 | 46 ± 12.73 | 42.96 ± 12.28 | 44.34 ± 14.82 |
| Sex: Female, Male(Participants) | Active tDCS and Active Mirror Therapy | Active tDCS and Sham Mirror Therapy | Sham tDCS and Active Mirror Therapy | Sham tDCS and Sham Mirrory Therapy | Total |
|---|---|---|---|---|---|
| Female | 7 | 10 | 11 | 10 | 38 |
| Male | 22 | 18 | 17 | 17 | 74 |
| Race (NIH/OMB)(Participants) | Active tDCS and Active Mirror Therapy | Active tDCS and Sham Mirror Therapy | Sham tDCS and Active Mirror Therapy | Sham tDCS and Sham Mirrory Therapy | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 0 | 0 | 2 |
| Asian | 0 | 1 | 1 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 7 | 6 | 6 | 6 | 25 |
| White | 14 | 15 | 15 | 15 | 59 |
| More than one race | 4 | 5 | 5 | 5 | 19 |
| Unknown or Not Reported | 3 | 0 | 1 | 0 | 4 |
| Region of Enrollment(Participants) | Active tDCS and Active Mirror Therapy | Active tDCS and Sham Mirror Therapy | Sham tDCS and Active Mirror Therapy | Sham tDCS and Sham Mirrory Therapy | Total |
|---|---|---|---|---|---|
| United States | 10 | 9 | 10 | 10 | 39 |
| Brazil | 19 | 19 | 18 | 17 | 73 |
| Phantom Limb Pain(units on a scale) | Active tDCS and Active Mirror Therapy | Active tDCS and Sham Mirror Therapy | Sham tDCS and Active Mirror Therapy | Sham tDCS and Sham Mirrory Therapy | Total |
|---|---|---|---|---|---|
| Mean | 6.12 ± 1.88 | 6.29 ± 1.67 | 6.09 ± 1.75 | 5.90 ± 1.57 | 6.08 ± 1.71 |
PDFs hosted by the registry, ClinicalTrials.gov.
The record gives a start of Jul 2015, a primary completion of Mar 2020 and a completion of Dec 2026. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2021, 1 year 2 months after primary completion.
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This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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