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

Last updated: February 14, 2025
Sponsor: Spaulding Rehabilitation Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Pain

Treatment

M1 anodal home-based tDCS

Somatosensory Training

Usual Care

Clinical Study ID

NCT05188183
2021P003323
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age - older than 18 years

  2. Limb amputation

  3. Patients who experience PLP regularly (at least once a week)

  4. Pain not attributable to other causes, such as peripheral inflammation

  5. Current chronic pain as defined by an average pain of at least 4 on the numericrating scale (NRS, 0: no pain, 10: worst imaginable pain)

Exclusion

Exclusion Criteria:

  1. Any clinically significant or unstable medical or psychiatric disorder

  2. History of substance abuse in the past 6 months (according to the DSM-V criteria forsubstance use disorder with six or more symptoms)

  3. Uncompensated psychiatric disorder

  4. Previous significant neurological history with current significant neurologicaldeficits

  5. Previous neurosurgical procedure with craniectomy that would affect currentdistribution of tDCS

  6. Contraindications to tDCS (implanted brain medical devices)

Study Design

Total Participants: 290
Treatment Group(s): 3
Primary Treatment: M1 anodal home-based tDCS
Phase:
Study Start date:
September 01, 2022
Estimated Completion Date:
July 31, 2027

Study Description

The investigators have designed a pragmatic trial of home-based tDCS for 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 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.

The investigators will perform a pragmatic, parallel randomized clinical trial. Investigators will recruit 290 participants with upper and/or lower bilateral or unilateral limb amputation and phantom limb pain in the chronic phase. All participants will be randomized to receive 20 daily sessions (4 weeks) of active anodal M1 home-based tDCS combined with somatosensory training or usual care. The participants will participate in 23 visits over 12 weeks.

Connect with a study center

  • Spaulding Hospital Cambridge

    Cambridge, Massachusetts 02138
    United States

    Active - Recruiting

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