Home-Based Transcranial Direct Current Stimulation and Somatosensory Training for Treating Phantom Limb Pain with Machine Learning Prediction

What this Trial Is About

Researchers are evaluating a home-based transcranial direct current stimulation tDCS combined with somatosensory training for people experiencing phantom limb pain PLP. This pragmatic trial, called PLP-EVEREST, aims to test a portable tDCS device in a real-world setting to reach underrepresented populations and compare this combined treatment to usual care, which includes pharmacological treatments, physical therapy, and occupational therapy. The study will assess whether this combined approach leads to a larger effect on reducing PLP compared to usual care alone. Participants with upper or lower limb amputations and chronic phantom limb pain will be randomly assigned to either receive 20 daily sessions over 4 weeks of active anodal M1 home-based tDCS combined with somatosensory training or continue with their usual care. The tDCS device delivers low-level electrical currents through scalp electrodes, and the somatosensory training involves relaxation exercises and imagined movements of the phantom limb performed during self-administration of tDCS. Those in the usual care group will be offered the combined treatment after the trial. Participants will complete a total of 23 visits over 12 weeks. Researchers will monitor their pain using the Visual Analogue Scale from baseline to 4 weeks. The study includes assessments of pain levels and treatment response while tracking adherence to the home-based protocol. Safety and effectiveness of the combined therapy will be evaluated in this pragmatic clinical trial setting.

Pragmatic Trial of Remote tDCS and Somatosensory Training for Phantom Limb Pain With Machine Learning to Predict Treatment Response