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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
Massachusetts
Spaulding Hospital Cambridge
RECRUITING
Cambridge
Contact Information
Primary
Felipe Fregni, MD, PhD, MPH, MMSc
ffregni@partners.org
617-952-6158
Backup
Kevin Pacheco-Barrios, MS, MSc, MPH
kpachecobarrios@mgh.harvard.edu
617-952-6195
Time Frame
Start Date: 2022-09-01
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 290
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Spaulding Rehabilitation Hospital

This content was sourced from clinicaltrials.gov