Trial Outcomes & Findings for Optimizing Rehabilitation for Phantom Limb Pain Using Mirror Therapy and Transcranial Direct Current Stimulation (tDCS) (NCT NCT02487966)

Last Updated: 2025-09-25

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

Target enrollment

132 participants

Primary outcome timeframe

4 weeks

Results posted on

2025-09-25

Participant Flow

Please note that from 132 subjects enrolled, 112 started (were randomized) as 20 subjects screened out after signing the consent form (time commitment=8; loss of interest=5; no more phantom limb pain=3; personal reasons=4).

Participant milestones

Participant milestones
Measure	Active tDCS and Active Mirror Therapy Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of active Mirror Therapy. transcranial Direct Current Stimulation (tDCS): active (Soterix ©): 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: active: 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.	Active tDCS and Sham Mirror Therapy Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of sham Mirror Therapy. transcranial Direct Current Stimulation (tDCS): active (Soterix ©): 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: Sham: 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.	Sham tDCS and Active Mirror Therapy Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of active Mirror Therapy. Mirror Therapy: active: 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 ©): 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.	Sham tDCS and Sham Mirrory Therapy Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of sham Mirror Therapy. transcranial Direct Current Stimulation (tDCS): sham (Soterix ©): 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: Sham: 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.
Overall Study STARTED	29	28	28	27
Overall Study COMPLETED	28	24	26	25
Overall Study NOT COMPLETED	1	4	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active tDCS and Active Mirror Therapy n=29 Participants Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of active Mirror Therapy. transcranial Direct Current Stimulation (tDCS): active (Soterix ©): 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: active: 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.	Active tDCS and Sham Mirror Therapy n=28 Participants Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of sham Mirror Therapy. transcranial Direct Current Stimulation (tDCS): active (Soterix ©): 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: Sham: 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.	Sham tDCS and Active Mirror Therapy n=28 Participants Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of active Mirror Therapy. Mirror Therapy: active: 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 ©): 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.	Sham tDCS and Sham Mirrory Therapy n=27 Participants Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of sham Mirror Therapy. transcranial Direct Current Stimulation (tDCS): sham (Soterix ©): 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: Sham: 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.	Total n=112 Participants Total of all reporting groups
Age, Continuous	48.24 years STANDARD_DEVIATION 16.28 • n=5 Participants	39.96 years STANDARD_DEVIATION 15.96 • n=7 Participants	46 years STANDARD_DEVIATION 12.73 • n=5 Participants	42.96 years STANDARD_DEVIATION 12.28 • n=4 Participants	44.34 years STANDARD_DEVIATION 14.82 • n=21 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	10 Participants n=7 Participants	11 Participants n=5 Participants	10 Participants n=4 Participants	38 Participants n=21 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	18 Participants n=7 Participants	17 Participants n=5 Participants	17 Participants n=4 Participants	74 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	25 Participants n=21 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	15 Participants n=7 Participants	15 Participants n=5 Participants	15 Participants n=4 Participants	59 Participants n=21 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	19 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Region of Enrollment United States	10 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants	10 Participants n=4 Participants	39 Participants n=21 Participants
Region of Enrollment Brazil	19 Participants n=5 Participants	19 Participants n=7 Participants	18 Participants n=5 Participants	17 Participants n=4 Participants	73 Participants n=21 Participants
Phantom Limb Pain	6.12 units on a scale STANDARD_DEVIATION 1.88 • n=5 Participants	6.29 units on a scale STANDARD_DEVIATION 1.67 • n=7 Participants	6.09 units on a scale STANDARD_DEVIATION 1.75 • n=5 Participants	5.90 units on a scale STANDARD_DEVIATION 1.57 • n=4 Participants	6.08 units on a scale STANDARD_DEVIATION 1.71 • n=21 Participants

PRIMARY outcome

Timeframe: 4 weeks

Outcome measures

Outcome measures
Measure	Active tDCS and Active Mirror Therapy n=29 Participants Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of active Mirror Therapy. transcranial Direct Current Stimulation (tDCS): active (Soterix ©): 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: active: 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.	Active tDCS and Sham Mirror Therapy n=28 Participants Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of sham Mirror Therapy. transcranial Direct Current Stimulation (tDCS): active (Soterix ©): 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: Sham: 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.	Sham tDCS and Active Mirror Therapy n=28 Participants Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of active Mirror Therapy. Mirror Therapy: active: 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 ©): 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.	Sham tDCS and Sham Mirrory Therapy n=27 Participants Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of sham Mirror Therapy. transcranial Direct Current Stimulation (tDCS): sham (Soterix ©): 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: Sham: 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	-2.84 units on a scale Standard Deviation 2.95	-3.35 units on a scale Standard Deviation 3.24	-1.78 units on a scale Standard Deviation 2.96	-2.58 units on a scale Standard Deviation 2.78

SECONDARY outcome

Timeframe: 4 weeks

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.

Outcome measures

Outcome measures
Measure	Active tDCS and Active Mirror Therapy n=29 Participants Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of active Mirror Therapy. transcranial Direct Current Stimulation (tDCS): active (Soterix ©): 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: active: 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.	Active tDCS and Sham Mirror Therapy n=28 Participants Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of sham Mirror Therapy. transcranial Direct Current Stimulation (tDCS): active (Soterix ©): 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: Sham: 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.	Sham tDCS and Active Mirror Therapy n=28 Participants Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of active Mirror Therapy. Mirror Therapy: active: 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 ©): 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.	Sham tDCS and Sham Mirrory Therapy n=27 Participants Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of sham Mirror Therapy. transcranial Direct Current Stimulation (tDCS): sham (Soterix ©): 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: Sham: 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 Stump Pain	-1.31 units on a scale Standard Deviation 2.99	-1.9 units on a scale Standard Deviation 3.99	-0.91 units on a scale Standard Deviation 2.94	-0.96 units on a scale Standard Deviation 2.84

SECONDARY outcome

Timeframe: 4 weeks

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.

Outcome measures

Outcome measures
Measure	Active tDCS and Active Mirror Therapy n=29 Participants Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of active Mirror Therapy. transcranial Direct Current Stimulation (tDCS): active (Soterix ©): 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: active: 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.	Active tDCS and Sham Mirror Therapy n=28 Participants Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of sham Mirror Therapy. transcranial Direct Current Stimulation (tDCS): active (Soterix ©): 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: Sham: 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.	Sham tDCS and Active Mirror Therapy n=28 Participants Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of active Mirror Therapy. Mirror Therapy: active: 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 ©): 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.	Sham tDCS and Sham Mirrory Therapy n=27 Participants Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of sham Mirror Therapy. transcranial Direct Current Stimulation (tDCS): sham (Soterix ©): 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: Sham: 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 Sensation	-1.86 units on a scale Standard Deviation 2.55	-2.55 units on a scale Standard Deviation 2.64	-1.35 units on a scale Standard Deviation 2.64	-2.83 units on a scale Standard Deviation 3.87

Adverse Events

Active tDCS and Active Mirror Therapy

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Active tDCS and Sham Mirror Therapy

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Sham tDCS and Active Mirror Therapy

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Sham tDCS and Sham Mirrory Therapy

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Active tDCS and Active Mirror Therapy n=29 participants at risk Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of active Mirror Therapy. transcranial Direct Current Stimulation (tDCS): active (Soterix ©): 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: active: 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.	Active tDCS and Sham Mirror Therapy n=28 participants at risk Subjects will receive 20 minutes of active tDCS, while receiving 15 minutes of sham Mirror Therapy. transcranial Direct Current Stimulation (tDCS): active (Soterix ©): 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: Sham: 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.	Sham tDCS and Active Mirror Therapy n=28 participants at risk Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of active Mirror Therapy. Mirror Therapy: active: 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 ©): 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.	Sham tDCS and Sham Mirrory Therapy n=27 participants at risk Subjects will receive 20 minutes of sham tDCS, while receiving 15 minutes of sham Mirror Therapy. transcranial Direct Current Stimulation (tDCS): sham (Soterix ©): 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: Sham: 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.
Skin and subcutaneous tissue disorders Tingling sensation over stimulation area	24.1% 7/29 • Number of events 35 • 3 months adverse effects were collected with a questionnaire for adverse effects	21.4% 6/28 • Number of events 32 • 3 months adverse effects were collected with a questionnaire for adverse effects	21.4% 6/28 • Number of events 29 • 3 months adverse effects were collected with a questionnaire for adverse effects	22.2% 6/27 • Number of events 30 • 3 months adverse effects were collected with a questionnaire for adverse effects

Additional Information

Dr. Felipe Fregni

Spaulding Rehabilitation Hospital

Phone: 6179526158

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place