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
256 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The investigators have designed a pragmatic trial of home-based transcranial direct current stimulation (tDCS) for phantom limb pain (PLP), the PLP-EVEREST trial (PLP-EffectiVEness pRagmatic Stimulation Trial) to test a portable device that would reach underrepresented populations and would validate this therapy in a more pragmatic setting. Subjects will be randomized to home-based tDCS of the primary motor cortex (M1) with somatosensory training or usual care only (including their current pharmacological treatments, physical therapy, and occupational therapy). The investigators will therefore test the effectiveness of home-based tDCS and somatosensory training in a real-world, home-based setting. The Investigator will compare patients randomized to this combined strategy vs. usual care alone (subjects from this group will be offered combined treatment at the end of the trial). The investigators hypothesize that the combined strategy will be associated with a significantly larger Cohen's d effect size (at least 1) compared to the control group.
CONDITIONS
Official 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 regularly (at least once a week)
- Pain not caused by other conditions such as peripheral inflammation
- Current chronic pain defined by an average pain of at least 4 on a numeric rating scale (0 to 10)
You will not qualify if you...
- Any clinically significant or unstable medical or psychiatric disorder
- History of substance abuse in the past 6 months according to DSM-V criteria
- Uncompensated psychiatric disorder
- Significant neurological history with current neurological deficits
- Previous neurosurgical procedure with craniectomy affecting tDCS distribution
- Contraindications to tDCS, such as implanted brain medical devices
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
K
Kevin Pacheco-Barrios, MS, MSc, MPH
CONTACT
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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