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

Launched by SPAULDING REHABILITATION HOSPITAL · Jan 10, 2022

Keywords

ClinConnect Summary

The PLP-EVEREST trial is a study looking at how effective a home-based treatment called transcranial direct current stimulation (tDCS) is for people suffering from phantom limb pain (PLP). Phantom limb pain is a common issue for individuals who have had a limb amputated, where they still feel pain in the area where their limb used to be. In this trial, participants will either receive the tDCS treatment along with special sensory training or continue with their usual care, which may include medications and physical therapy. The goal is to see if the combined treatment of tDCS and sensory training can significantly reduce pain compared to usual care alone.

To be eligible for this trial, participants must be over 18 years old, have undergone a limb amputation, and experience phantom limb pain at least once a week. They should also have a minimum pain level of 4 out of 10 on a pain scale. However, individuals with certain medical or psychiatric conditions, recent substance abuse, or previous significant neurological issues may not qualify. Those who participate can expect to use a portable device at home and receive guidance on the sensory training, contributing to important research aimed at helping others with similar pain issues in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age - older than 18 years
• • 2. Limb amputation
• • 3. Patients who experience PLP regularly (at least once a week)
• • 4. Pain not attributable to other causes, such as peripheral inflammation
• • 5. 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:
• • 1. Any clinically significant or unstable medical or psychiatric disorder
• • 2. History of substance abuse in the past 6 months (according to the DSM-V criteria for substance use disorder with six or more symptoms)
• • 3. Uncompensated psychiatric disorder
• • 4. Previous significant neurological history with current significant neurological deficits
• • 5. Previous neurosurgical procedure with craniectomy that would affect current distribution of tDCS
• • 6. Contraindications to tDCS (implanted brain medical devices)