RecruitingNot ApplicableNCT07174609

Scrambler Therapy in Chronic Pancreatitis

A Pilot Study of Scrambler Therapy for Painful Chronic Pancreatitis


Sponsor

Johns Hopkins University

Enrollment

40 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • 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

Exclusion Criteria7

  • Unable or unwilling to provide written consent
  • History or presence of a significant medical or psychiatric condition that would interfere with study participation
  • Pregnant or lactating women
  • Coronary stents or implanted metallic/electrical devices (pacemaker, defibrillator, aneurysm clips)
  • History of epilepsy, traumatic brain injury, or myocardial infarction within the past 6 months
  • Skin conditions preventing electrode placement (e.g., open wounds)
  • Any condition that, in the investigator's opinion, places the participant at increased risk or prevents full compliance with study procedures

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Interventions

DEVICEScrambler Therapy

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.


Locations(1)

Johns Hopkins Green Spring Station

Baltimore, Maryland, United States

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NCT07174609


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