A Pilot Study of Scrambler Therapy for Painful Chronic Pancreatitis

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults aged 18 years and older

• Diagnosis of chronic pancreatitis with refractory abdominal pain

• Able to provide written informed consent in English

• Sufficient English language ability to complete study questionnaires

• Reliable and regular access to a phone for follow-up

Locations
United States
Maryland
Johns Hopkins Green Spring Station
RECRUITING
Baltimore
Contact Information
Primary
Mahya Faghih
mfaghih2@jh.edu
443-287-4680
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 40
Treatments
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.
Sponsors
Collaborators: The National Pancreas Foundation
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov