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

Study acronym: PLP-EVEREST
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv9
  2. Start date: Sep 13, 2022 to Sep 1, 2022v8
  3. Primary completion date: Mar 29, 2027 to Jun 30, 2027
    • Study completion date: May 31, 2027 to Jul 31, 2027
    v7
  4. Re-verified, no change to tracked fieldsv6
  5. Primary completion date: Jul 2027 to Mar 29, 2027
    • Study completion date: Jul 2028 to May 31, 2027
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Primary completion date: Mar 29, 2027 to Jul 2027
    • Study completion date: May 31, 2027 to Jul 2028
    • Start date: Oct 1, 2022 to Sep 13, 2022
    v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 1, 2022 to Oct 1, 2022
    v3
  3. Lead sponsor: [Redacted] to Spaulding Rehabilitation Hospitalv2 Show 5 more changesShow less
    • Trial status: Withheld to Not Yet Recruiting
    • Primary completion date: Mar 29, 2027
    • Study completion date: May 31, 2027
    • Start date: Sep 1, 2022
    • Study title expanded, about 6 words
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT05188183
Lead Sponsor Spaulding Rehabilitation Hospital
Conditions
(from sponsor)		 Phantom Limb Pain
Related terms Phantom Limb
Enrollment 290 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov