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NCT05188183 · ClinicalTrials.gov registry record · NA
Pragmatic Trial of Remote tDCS and Somatosensory Training for Phantom Limb Pain With Machine Learning to Predict Treatment Response
A NA study of Phantom Limb Pain, sponsored by Spaulding Rehabilitation Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 290
- Enrollment target
- 1
- Study location
NCT05188183: Recruiting NA study of Phantom Limb Pain, sponsored by Spaulding Rehabilitation Hospital.
NCT05188183 is a NA study of Phantom Limb Pain that is actively recruiting participants, run by Spaulding Rehabilitation Hospital. The registered enrollment target is 290 participants, above the 98-participant average among 12 other Phantom Limb Pain trials with a reported enrollment target (196% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05188183, a NA study of Phantom Limb Pain, is actively recruiting participants, sponsored by Spaulding Rehabilitation Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 290 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 l
Conditions Studied
Interventions
- OTHER Usual Care
- DEVICE M1 anodal home-based tDCS
- BEHAVIORAL Somatosensory Training
Study Locations (1)
Massachusetts
- Spaulding Hospital Cambridge - Cambridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 290 participants |
| Start Date | 2022-09-01 |
| Est. Completion | 2027-07-31 |
| Phase | NA |
What NCT05188183 shows while recruiting
NCT05188183 is an interventional study that assigns participants to a tested intervention. The registered 290 participants enrollment target is mid-sized for trials with a published cap, above the 98-participant average among 12 other Phantom Limb Pain trials with a reported enrollment target (196% higher).
The record links to 1 condition, with Phantom Limb Pain appearing as the primary indexed condition, and to 3 interventions - of which Usual Care is the first listed.
NCT05188183 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05188183 about?
NCT05188183 is a clinical study titled "Pragmatic Trial of Remote tDCS and Somatosensory Training for Phantom Limb Pain With Machine Learning to Predict Treatment Response". 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...
What is the current status of trial NCT05188183?
This trial is currently recruiting. It is a NA study. The enrollment target is 290 participants. The study started on 2022-09-01. Estimated completion is 2027-07-31.
What conditions does trial NCT05188183 study?
This clinical trial studies the following conditions: Phantom Limb Pain.
What interventions are being tested in trial NCT05188183?
The interventions under investigation include: Usual Care (OTHER), M1 anodal home-based tDCS (DEVICE), Somatosensory Training (BEHAVIORAL).
Who is sponsoring clinical trial NCT05188183?
This trial is sponsored by Spaulding Rehabilitation Hospital, which has 101 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05188183 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05188183's enrollment target sits among peer trials
290 2nd of 12 the highest of 12 other Phantom Limb Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phantom Limb Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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