Recruiting

TDCS & Somatosensory Training

Sponsor:

Spaulding Rehabilitation Hospital

Code:

NCT05188183

Conditions

Phantom Limb Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

M1 anodal home-based tDCS

Somatosensory Training

Usual Care

Study Details

Brief 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.

Conditions

Phantom Limb Pain

Study ID

NCT05188183

Start date

Sep 1, 2022

Status verified date

Sep, 2025

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 numeric rating scale (NRS, 0: no pain, 10: worst imaginable pain)

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 for substance use disorder with six or more symptoms)
3. Uncompensated psychiatric disorder
4. Previous significant neurological history with current significant neurological deficits
5. Previous neurosurgical procedure with craniectomy that would affect current distribution of tDCS
6. Contraindications to tDCS (implanted brain medical devices)

Study Design

Enrollment

290 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

M1 anodal home-based tDCS

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

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

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 and Locations

Central contacts

Felipe Fregni, MD, PhD, MPH, MMSc

617-952-6158ffregni@partners.org

Kevin Pacheco-Barrios, MS, MSc, MPH

617-952-6195kpachecobarrios@mgh.harvard.edu

Locations

Spaulding Hospital Cambridge

Recruiting

Cambridge, Massachusetts, United States, 02138

Contacts

Elly Pichardo, MD

6179526158epichardo@partners.org

Principal Investigator:

Felipe Fregni, MD, PhD, MMSc, MPH, MEd

More Information

Sponsor

Spaulding Rehabilitation Hospital

Last update posted

Sep 19, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Spaulding Rehabilitation Hospital on 2025-09-19.