Pragmatic Trial of Remote tDCS and Somatosensory Training for Phantom Limb Pain With Machine Learning to Predict Treatment Response
Recruiting now · Not applicable
Conditions studied: Phantom Limb Pain
In brief
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.
Key facts
- Study ID
- NCT05188183
- Run by
- Spaulding Rehabilitation Hospital
- People needed
- 290
- Starts
- 2022-09-01
- Expected to finish
- 2027-07-31
- Last updated by the study team
- 2025-09-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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)
Where it is running
- Spaulding Hospital Cambridge — Cambridge, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
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