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

Part of paid clinical trials in Cambridge, Massachusetts.

Sponsor
Spaulding Rehabilitation Hospital
Study ID
NCT05188183
Status
Recruiting
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Conditions

  • Phantom Limb Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • M1 anodal home-based tDCS — DEVICE
    During tDCS, low amplitude direct currents are applied via scalp electrodes and penetrate the skull to enter the brain. Direct current will be transferred by a saline-soaked pair of surface sponge electrodes (35 cm2) and delivered by a specially developed, battery-driven, constant current stimulator with a maximum output of 10 mA.
  • Somatosensory Training — BEHAVIORAL
    The somatosensory training will be performed during the self-administration of tDCS, including 20 sessions over 4 weeks. Sessions will start with relaxation exercises using a body scan technique, whereby subjects in a relaxed state will be instructed to sequentially interchange their mind to different regions of the body while perceiving it and establishing contact with the body part. Subjects will be asked to concentrate on any feeling (kinetic, kinesthetic or exteroceptive) related to each body part. Phantom exercises will involve the use of imagined movements of the phantom limb. Therefore, patients will be asked to perform general exercises with their phantom limb. Exercises will include hip, knee, ankle, and toe movements.
  • Usual Care — OTHER
    Usual care includes pharmacological treatments, physical therapy, occupational therapy and/or behavioral therapy that the subject is receiving.

Study Details

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 Dates

Start date
Sep 1, 2022
Status verified
Sep 2025
Primary completion
Jun 30, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
290 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: M1 anodal home-based tDCS and somatosensory training
    Investigators will use the Soterix Medical 1X1 tDCS mini-CT stimulator device (© Soterix Medical Inc.) an home-based tDCS device used in several clinical trials with no adverse events. It sends a low-level current from the positive electrode, anode, to the negative electrode, cathode. During tDCS, low amplitude direct currents are applied via scalp electrodes and penetrate the skull to enter the brain. HB-TDCS will be combined with somatosensory training that will be performed during the self-administration of tDCS, including 20 sessions over 4 weeks.
  • Experimental: Usual Care
    Usual care includes pharmacological treatments, physical therapy, occupational therapy and/or behavioral therapy that the subject is receiving.

Primary Outcome Measure

Visual Analogue Scale (VAS) for Phantom Limb Pain [ Time Frame: From Baseline to Visit 22 (at 4 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Spaulding Hospital CambridgeCambridgeMassachusetts02138
Elly Pichardo, MD
[email protected]
6179526158
Felipe Fregni, MD, PhD, MMSc, MPH, MEd (PRINCIPAL_INVESTIGATOR)

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