Long-term Effects of Transcranial Direct Current Stimulation (tDCS) on Patients With Phantom Limb Pain (PLP)
Phantom Limb Pain
About this trial
This is an interventional treatment trial for Phantom Limb Pain focused on measuring Phantom Limb Pain, Transcranial Direct Current Stimulation, Amputation, Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Age 18 to 80
- Limb amputation from at least 6 months before study enrollment
- Presence of PLP at least 2 times a week and present 4 weeks prior to onset of study
- Written informed consent
Exclusion Criteria:
- Coexistence of major neurological or psychiatric diseases
- Being actively enrolled in a separate study targeting pain relief
- Post traumatic stress disorder (PTSD) diagnosed patients
- Any contraindication to noninvasive brain stimulation such as past brain surgery, brain implants, cochlear implant, epilepsy or any past seizure
- Pregnant women
- Within the traumatic amputees group - subjects diagnosed with diabetes
Sites / Locations
- Department of Orthopedic Rehabilitation, Sheba Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Crossover 1a: anodal stimulation of M1 + sham
Crossover 1b: sham + anodal stimulation of M1
Crossover 2a: cathodal stimulation of M1 + sham
Crossover 2b: sham + cathodal stimulation of M1
6 amputees will undergo 8 active treatments of 20 min 2mA anodal stimulation of M1 localized to the contralateral amputation area followed by 8 sham treatments. Total duration and frequency of treatments: 8 weeks, 2 sessions per week. Each session will last approximately one hour which will consist of: EEG and pain measurements 20 minutes of stimulation EEG and pain measurements after completion of stimulation
6 amputees will undergo 8 sham treatments followed by 8 active treatments of 20 min 2mA anodal stimulation of M1 localized to the contralateral amputation area. Total duration and frequency of treatments: 8 weeks, 2 sessions per week. Each session will last approximately one hour which will consist of: EEG and pain measurements 20 minutes of stimulation EEG and pain measurements after completion of stimulation
6 amputees will undergo 8 active treatments of 20 min 2mA cathodal stimulation of M1 localized to the contralateral amputation area followed by 8 sham treatments. Total duration and frequency of treatments: 8 weeks, 2 sessions per week. Each session will last approximately one hour which will consist of: EEG and pain measurements 20 minutes of stimulation EEG and pain measurements after completion of stimulation
6 amputees will undergo 8 sham treatments followed by 8 active treatments of 20 min 2mA cathodal stimulation of M1 localized to the contralateral amputation area. Total duration and frequency of treatments: 8 weeks, 2 sessions per week. Each session will last approximately one hour which will consist of: EEG and pain measurements 20 minutes of stimulation EEG and pain measurements after completion of stimulation