Scrambler Therapy in Chronic Pancreatitis

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT07174609
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Scrambler Therapy — DEVICE
    Adults with chronic pancreatitis and refractory abdominal pain will receive Scrambler Therapy, a non-invasive neuromodulation device. Electrodes are placed near the painful area to deliver "non-pain" signals aimed at reducing pain perception. Participants will complete 5-10 daily treatment sessions, each lasting 30-40 minutes, with pain ratings collected before and after sessions and follow-up assessments over 3 months.

Study Details

The investigators will enroll adults with chronic pancreatitis who have persistent abdominal pain not relieved by standard treatments. This study will test the feasibility and effectiveness of Scrambler Therapy, a non-invasive FDA-cleared device that delivers "non-pain" electrical signals through the skin to retrain the brain's pain perception. Participants will undergo 5-10 treatment sessions and be followed for 3 months with standardized pain scores and quality-of-life assessments. The goal is to generate pilot data to support larger studies of Scrambler Therapy as a novel option for pancreatic pain.

Key Dates

Start date
Nov 1, 2024
Status verified
Sep 2025
Primary completion
Dec 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Scrambler Therapy for Chronic Pancreatitis Pain
    Adults with chronic pancreatitis and refractory abdominal pain will receive Scrambler therapy. Scrambler Therapy is a non-invasive neuromodulation treatment designed to relieve chronic pain by transmitting "non-pain" electrical signals through the skin to the nervous system. The device generates 16 variable waveforms that mimic natural nerve impulses, creating patient-specific cutaneous electrostimulation. These signals are carried by afferent C-fibers and interpreted by the central nervous system as non-painful, thereby modulating pain perception rather than blocking it.

Primary Outcome Measure

Feasibility as assessed by enrollment rate [ Time Frame: During recruitment ( expected 24 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins Green Spring StationBaltimoreMaryland21205
Mahya Faghih, MD
[email protected]
443-287-4680

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By research site
Johns Hopkins Green Spring Station· Baltimore, MD

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