Actively Recruiting
Pragmatic Trial of Remote tDCS and Somatosensory Training for Phantom Limb Pain With Machine Learning to Predict Treatment Response
Led by Spaulding Rehabilitation Hospital · Updated on 2025-09-19
290
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Pragmatic Trial of Remote tDCS and Somatosensory Training for Phantom Limb Pain With Machine Learning to Predict Treatment Response
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age older than 18 years
- Limb amputation
- Experience phantom limb pain at least once a week
- Pain not caused by other conditions like peripheral inflammation
- Current chronic pain with an average rating of at least 4 on a 0 to 10 pain scale
You will not qualify if you...
- Any significant or unstable medical or psychiatric disorder
- Substance abuse history in past 6 months
- Uncompensated psychiatric disorder
- Significant neurological history with current neurological deficits
- Previous brain surgery with craniectomy affecting tDCS
- Contraindications to tDCS such as implanted brain medical devices
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 4 weeks
Participants receive 20 daily sessions over 4 weeks of either home-based M1 anodal tDCS combined with somatosensory training or continue with their usual care including pharmacological treatments and therapy.
23 visits over 12 weeks
Trial Site Locations
Total: 1 location
1
Spaulding Hospital Cambridge
Cambridge, Massachusetts, United States, 02138
Actively Recruiting
Research Team
F
Felipe Fregni, MD, PhD, MPH, MMSc
K
Kevin Pacheco-Barrios, MS, MSc, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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