Scrambler Therapy in Chronic Pancreatitis

NCT07174609 | Recruiting FDA Device

• 1 other identifier: IRB00469056
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Feasibility as assessed by enrollment rate

  Number of eligible patients who consent and enroll divided by the total number of eligible patients approached.

  During recruitment ( expected 24 months)

• Feasibility as assessed by treatment adherence

  Number of participants who complete a minimum of 5 Scrambler Therapy sessions out of the planned 5-10, or who discontinue earlier due to achieving adequate pain relief.

  During treatment period (up to 2 weeks)

• Feasibility as assessed by treatment adherence rate

  Proportion of participants who complete a minimum of 5 Scrambler Therapy sessions out of the planned 5-10, or who discontinue earlier due to achieving adequate pain relief.

  During treatment period (average 5-10 days, up to 2 weeks)

• Feasibility as assessed by retention

  Proportion of enrolled participants who complete the 3-month follow-up assessments, including pain ratings.

  Baseline through 3 months post-treatment

Secondary Outcomes (11)

• Change in Pain Intensity (VAS)

  Baseline, 1 month, and 3 months after treatment

• Percentage of Patients with ≥30% Pain Reduction

  Baseline , 1 months and 3 months post-treatment

• Percentage of Patients with ≥50% Pain Reduction

  Baseline, 1 month and 3 months post-treatment

• Opioid use

  Baseline, 1 month and 3 months post-treatment

• Daily opioid dose( morphine milligram equivalents,MME)

  Baseline, 1 month and 3 months post-treatment

Other Outcomes (1)

• Adverse events - Frequency

  During treatment ( up to 2 weeks)

Study Arms (1)

Scrambler Therapy for Chronic Pancreatitis Pain

EXPERIMENTAL

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.

Device: Scrambler Therapy

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.

Scrambler Therapy for Chronic Pancreatitis Pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• The National Pancreas Foundation: collaborator

Study Sites (1)

Johns Hopkins Green Spring Station

Baltimore, Maryland, 21205, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Pancreatitis; Pancreatitis, Chronic; Abdominal Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Signs and Symptoms, Digestive

Study Officials

• Mahya Faghih

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahya Faghih

CONTACT

443-287-4680; mfaghih2@jh.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-arm feasibility study using a Single Group Assignment design. All participants with chronic pancreatitis and refractory abdominal pain will receive Scrambler Therapy, consisting of 5-10 daily treatment sessions lasting 30-40 minutes. There is no randomization or control arm. Outcomes will include feasibility measures (enrollment, adherence, and retention), as well as changes in pain severity, opioid use, and patient-reported quality of life over 3 months of follow-up. The purpose is to generate preliminary safety and effectiveness data to support future controlled trials.

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 16, 2025
• Study Start: November 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)