Phantom Limb Pain
Conditions
Keywords
maladaptive plasticity, Limb amputation, phantom limb pain, tDCS, non-invasive brain stimulation
Brief summary
This study explores the effects transcranial Direct Current Stimulation (tDCS, Soterix ©) on Phantom Limb Pain for patients experiencing chronic phantom limb pain in open-label study design.
Interventions
DEVICEtranscranial Direct Current Stimulation (tDCS): (Soterix ©)
Subjects will undergo tDCS stimulation. We will use electrodes of 35cm\^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated limb (or for bilateral amputees contralateral to the most painful side). The subject will undergo stimulation for 20 minutes. The subject will have 5 sessions of stimulation during a 1 week time period.
Sponsors
Spaulding Rehabilitation Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Able to provide informed consent to participate in the study. 2. Subject is older than 18 years. 3. 3 months of phantom limb pain (experienced regularly for at least once a week) after the amputated limb has completely healed. 4. Average pain of at least 4 on a numeric rating scale in the previous week (NRS; ranging from 0 to 10). 5. If the subject is taking any medications, dosages must be stable for at least 2 weeks prior to the enrollment of the study.
Exclusion criteria
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 Ferromagnetic metal in the head (e.g., plates or pins, bullets, shrapnel) Implanted head electronic medical devices (e.g., cochlear implants) 4. Head injury resulting in loss of consciousness for at least 30 min or pos-traumatic amnesia for greater than 24 hours, as self-reported 5. Unstable medical conditions (e.g. uncontrolled diabetes, uncompensated cardiac issues, heart failure or chronic obstructive pulmonary disease). 6. Uncontrolled Epilepsy 7. Suffering from severe depression (as defined by a score of \>30 in the Beck Depression Inventory).\* 8. History of unexplained fainting spells or loss of consciousness as self-reported during the last 2 years. 9. History of neurosurgery, as self-reported.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain as Measured by the Visual Analog Scale | Change in outcome from baseline to 2-week follow-up (after the last day of stimulation) | The VAS is a common assessment used which asks subjects to self-reportedly measure their pain on a visual scale (i.e., unbearable to none). We will use a VAS to determine subjects' pain scores. Subjects will rate their pain from 0 - indicating no pain at all, to 10 - indicating the worst pain felt. This scale is also colored, from green (at 0) to red (at 10), as a visual indicator of pain. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| tDCS Intervention (Open Label) Subjects will undergo tDCS stimulation
transcranial Direct Current Stimulation (tDCS): (Soterix ©): Subjects will undergo tDCS stimulation. We will use electrodes of 35cm\^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated limb (or for bilateral amputees contralateral to the most painful side). The subject will undergo stimulation for 20 minutes. The subject will have 5 sessions of stimulation during a 1 week time period. | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | tDCS Intervention (Open Label) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Age, Continuous | 54.6 years STANDARD_DEVIATION 16.58 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 9 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
Pain as Measured by the Visual Analog Scale
The VAS is a common assessment used which asks subjects to self-reportedly measure their pain on a visual scale (i.e., unbearable to none). We will use a VAS to determine subjects' pain scores. Subjects will rate their pain from 0 - indicating no pain at all, to 10 - indicating the worst pain felt. This scale is also colored, from green (at 0) to red (at 10), as a visual indicator of pain.
Time frame: Change in outcome from baseline to 2-week follow-up (after the last day of stimulation)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tDCS Intervention (Open Label) | Pain as Measured by the Visual Analog Scale | -1.4 units on a scale | Standard Deviation 1.14 |