Pragmatic Trial of Remote tDCS and Somatosensory Training for Phantom Limb Pain With Machine Learning to Predict Treatment Response (PLP-EVEREST)
Phantom Limb Pain
About this trial
This is an interventional treatment trial for Phantom Limb Pain
Eligibility Criteria
Inclusion Criteria:
- Age - older than 18 years
- Limb amputation
- Patients who experience PLP regularly (at least once a week)
- Pain not attributable to other causes, such as peripheral inflammation
- Current chronic pain as defined by an average pain of at least 4 on the numeric rating scale (NRS, 0: no pain, 10: worst imaginable pain)
Exclusion Criteria:
- Any clinically significant or unstable medical or psychiatric disorder
- History of substance abuse in the past 6 months (according to the DSM-V criteria for substance use disorder with six or more symptoms)
- Uncompensated psychiatric disorder
- Previous significant neurological history with current significant neurological deficits
- Previous neurosurgical procedure with craniectomy that would affect current distribution of tDCS
- Contraindications to tDCS (implanted brain medical devices)
Sites / Locations
- Spaulding Hospital CambridgeRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
M1 anodal home-based tDCS and somatosensory training
Usual Care
Investigators will use the Soterix Medical 1X1 tDCS mini-CT stimulator device (© Soterix Medical Inc.) an home-based tDCS device used in several clinical trials with no adverse events. It sends a low-level current from the positive electrode, anode, to the negative electrode, cathode. During tDCS, low amplitude direct currents are applied via scalp electrodes and penetrate the skull to enter the brain. HB-TDCS will be combined with somatosensory training that will be performed during the self-administration of tDCS, including 20 sessions over 4 weeks.
Usual care includes pharmacological treatments, physical therapy, occupational therapy and/or behavioral therapy that the subject is receiving.