RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-09-13
Study Completion:2027-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05188183

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age - older than 18 years
  2. 2. Limb amputation
  3. 3. Patients who experience PLP regularly (at least once a week)
  4. 4. Pain not attributable to other causes, such as peripheral inflammation
  5. 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)
  1. 1. Any clinically significant or unstable medical or psychiatric disorder
  2. 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. 3. Uncompensated psychiatric disorder
  4. 4. Previous significant neurological history with current significant neurological deficits
  5. 5. Previous neurosurgical procedure with craniectomy that would affect current distribution of tDCS
  6. 6. Contraindications to tDCS (implanted brain medical devices)

Contacts and Locations

Study Contact

Felipe Fregni, MD, PhD, MPH, MMSc
CONTACT
617-952-6158
ffregni@partners.org
Kevin Pacheco-Barrios, MS, MSc, MPH
CONTACT
617-952-6195
kpachecobarrios@mgh.harvard.edu

Study Locations (Sites)

Spaulding Hospital Cambridge
Cambridge, Massachusetts, 02138
United States

Collaborators and Investigators

Sponsor: Spaulding Rehabilitation Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-13
Study Completion Date2027-07-31

Study Record Updates

Study Start Date2022-09-13
Study Completion Date2027-07-31

Terms related to this study

Additional Relevant MeSH Terms

  • Phantom Limb Pain