Status:
RECRUITING
Pragmatic Trial of Remote tDCS and Somatosensory Training for Phantom Limb Pain With Machine Learning to Predict Treatment Response
Lead Sponsor:
Spaulding Rehabilitation Hospital
Conditions:
Phantom Limb Pain
Eligibility:
All Genders
18+ years
Phase:
NA
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 Stimulati...
Detailed Description
The investigators have designed a pragmatic trial of home-based tDCS for PLP, the PLP-EVEREST trial (PLP-EffectiVEness pRagmatic Stimulation Trial) to test a portable device that would reach underrepr...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- Any clinically significant or unstable medical or psychiatric disorder
- History of substance abuse in the past 6 months (according to the DSM-V criteria for substance use disorder with six or more symptoms)
- Uncompensated psychiatric disorder
- Previous significant neurological history with current significant neurological deficits
- Previous neurosurgical procedure with craniectomy that would affect current distribution of tDCS
- Contraindications to tDCS (implanted brain medical devices)
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT05188183
Start Date
September 1 2022
End Date
July 31 2027
Last Update
September 19 2025
Active Locations (1)
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1
Spaulding Hospital Cambridge
Cambridge, Massachusetts, United States, 02138