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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSpaulding Rehabilitation Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • M1 anodal home-based tDCS
  • Somatosensory Training
  • Usual Care

Treatment groups

290 Participants
are divided into 2 treatment groups