NCT05188183 Pragmatic Trial of Remote tDCS and Somatosensory Training for Phantom Limb Pain With Machine Learning to Predict Treatment Response
| NCT ID | NCT05188183 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Spaulding Rehabilitation Hospital |
| Condition | Phantom Limb Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 290 participants |
| Start Date | 2022-09-01 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 290 participants in total. It began in 2022-09-01 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05188183 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Phantom Limb Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05188183 currently recruiting?
Yes, NCT05188183 is actively recruiting participants. Contact the research team at ffregni@partners.org for enrollment information.
Where is the NCT05188183 trial being conducted?
This trial is being conducted at Cambridge, United States.
Who is sponsoring the NCT05188183 clinical trial?
NCT05188183 is sponsored by Spaulding Rehabilitation Hospital. The trial plans to enroll 290 participants.