Pragmatic Trial of Remote tDCS and Somatosensory Training for Phantom Limb Pain With Machine Learning to Predict Treatment Response
PLP-EVEREST
1 other identifier
interventional
290
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2021
CompletedFirst Posted
Study publicly available on registry
January 12, 2022
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2027
September 19, 2025
September 1, 2025
4.8 years
December 10, 2021
September 15, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Visual Analogue Scale (VAS) for Phantom Limb Pain
The VAS is a common assessment that asks subjects to self-reportedly measure their pain on a visual scale (i.e., unbearable to none). Investigators will use the VAS to determine subjects' pain scores. Subjects will rate their pain from 0 - indicating no pain at all, to 10 - indicating the worst pain felt. This scale is also colored, from green (at 0) to red (at 10), as a visual indicator of pain. This assessment tool is frequently used in many research studies evaluating pain levels in phantom limb.
From Baseline to Visit 22 (at 4 weeks)
Study Arms (2)
M1 anodal home-based tDCS and somatosensory training
EXPERIMENTALInvestigators 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
EXPERIMENTALUsual care includes pharmacological treatments, physical therapy, occupational therapy and/or behavioral therapy that the subject is receiving.
Interventions
During tDCS, low amplitude direct currents are applied via scalp electrodes and penetrate the skull to enter the brain. Direct current will be transferred by a saline-soaked pair of surface sponge electrodes (35 cm2) and delivered by a specially developed, battery-driven, constant current stimulator with a maximum output of 10 mA.
The somatosensory training will be performed during the self-administration of tDCS, including 20 sessions over 4 weeks. Sessions will start with relaxation exercises using a body scan technique, whereby subjects in a relaxed state will be instructed to sequentially interchange their mind to different regions of the body while perceiving it and establishing contact with the body part. Subjects will be asked to concentrate on any feeling (kinetic, kinesthetic or exteroceptive) related to each body part. Phantom exercises will involve the use of imagined movements of the phantom limb. Therefore, patients will be asked to perform general exercises with their phantom limb. Exercises will include hip, knee, ankle, and toe movements.
Usual care includes pharmacological treatments, physical therapy, occupational therapy and/or behavioral therapy that the subject is receiving.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Spaulding Hospital Cambridge
Cambridge, Massachusetts, 02138, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Spaulding Neuromodulation Center
Study Record Dates
First Submitted
December 10, 2021
First Posted
January 12, 2022
Study Start
September 1, 2022
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
July 31, 2027
Last Updated
September 19, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
Upon completion of the trial and after publication of the primary manuscript, the investigators plan to publish the de-identified dataset following the guidelines of our institution (Spaulding Rehabilitation Hospital/Partners Healthcare and Harvard Medical School).