* Phantom limb pain (PLP) refers to pain in a limb that has been amputated or deafferented. Phantom limb pain might be related to brain cortical plastic changes. * The purpose of this study is to determine the efficacy of a series of transcranial direct current stimulation (tDCS) sessions, a non-invasive and focal brain stimulation method, in producing long-term reduction of phantom limb pain among amputees who experience such pain. This is a Crossover sham control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
8 active treatmments: 2mA anodal stimulation of M1 for 20 minutes (over the relevant cortex area) followed by 8 sham treatments.
8 sham treatments followed by 8 active treatmments: 2mA anodal stimulation of M1 for 20 minutes (over the relevant cortex area).
8 active treatmments: 2mA cathodal stimulation of M1 for 20 minutes (over the relevant cortex area) , followed by 8 sham treatments.
Department of Orthopedic Rehabilitation, Sheba Medical Center
Ramat Gan, Israel
Reduced phantom limb pain
Reduction of phantom limb pain compared to phantom limb pain before treatment, according to Visual Analog Scales (VAS) evaluation
Time frame: 5 months after last stimulation session
Adverse effects of treatment
Severity of any adverse effects related to the transcranial direct current stimulation treatment will be checked after each stimulation session
Time frame: Up to 5 weeks
Effects of treatment on the electrical activity of the brain
Measurement of the electrical activity of the brain before, during and after each stimulation using an electroencephalography (EEG) device.
Time frame: Up to 5 weeks
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8 sham treatments followed by 8 active treatmments: 2mA cathodal stimulation of M1 for 20 minutes (over the relevant cortex area).