Recruiting

Scrambler Therapy

Sponsor:

Johns Hopkins University

Code:

NCT07174609

Conditions

Chronic Pain

Pancreatitis

Chronic Pancreatitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Scrambler Therapy

Study Details

Brief 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.

Conditions

Chronic Pain

Pancreatitis

Chronic Pancreatitis

Study ID

NCT07174609

Start date

Nov 1, 2024

Status verified date

Sep, 2025

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Scrambler 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.

Primary outcome measure

  • Feasibility as assessed by enrollment rate [ Time Frame: During recruitment ( expected 24 months) ]
  • Feasibility as assessed by treatment adherence [ Time Frame: During treatment period (up to 2 weeks) ]
  • Feasibility as assessed by treatment adherence rate [ Time Frame: During treatment period (average 5-10 days, up to 2 weeks) ]
  • Feasibility as assessed by retention [ Time Frame: Baseline through 3 months post-treatment ]

Central Contacts and Locations

Central contacts

Mahya Faghih

443-287-4680mfaghih2@jh.edu

Locations

Johns Hopkins Green Spring Station

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Mahya Faghih, MD

443-287-4680mfaghih2@jh.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Sep 16, 2025

Last verified

Sep, 2025

Keywords

  • chronic pain
  • Abdominal pain
  • chronic pancreatitis
  • Scrambler Therapy
  • Electrocutaneous analgesia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2025-09-16.