Scrambler Therapy for Chronic Pancreatitis

Overseen By Mahya Faghih

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Pregnancy, Coronary stents, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1-2 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method called Scrambler Therapy for individuals with chronic pancreatitis who experience persistent abdominal pain unrelieved by standard treatments. Scrambler Therapy uses a device to send special electrical signals through the skin, altering the brain's perception of pain. Participants will undergo 5-10 treatment sessions and be monitored for three months to assess improvements in pain and quality of life. Individuals with chronic pancreatitis who have constant abdominal pain and can communicate in English may be suitable for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative pain relief methods and contribute to advancing treatment options for chronic pancreatitis.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to get a clear answer.

What prior data suggests that this device is safe for treating chronic pancreatitis pain?

Research shows that Scrambler Therapy is generally easy for patients to handle. This treatment uses a device to send "non-pain" signals through the skin, helping the brain change its perception of pain. Studies have found that this method can effectively relieve pain without causing major side effects. Scrambler Therapy is non-invasive, requiring no surgery, and the FDA has approved it, indicating its safety. In past uses for different types of pain, no serious side effects have been reported. Overall, current evidence supports the safety of Scrambler Therapy, making it a promising option for people with chronic pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for chronic pancreatitis pain, which often involve medications like opioids or nerve blocks, Scrambler Therapy takes a completely different approach. It uses non-invasive neuromodulation by sending "non-pain" electrical signals through the skin to the nervous system. This innovative technique tricks the brain into interpreting these signals as non-painful, thereby changing how pain is perceived rather than just blocking it. Researchers are excited because this could offer a drug-free, side-effect-free alternative for managing chronic pain, potentially improving patients' quality of life significantly.

What evidence suggests that Scrambler Therapy is effective for chronic pancreatitis pain?

Studies have shown that Scrambler Therapy, which participants in this trial will receive, can greatly reduce pain in people with chronic conditions. In one study, about 80% of patients experienced more than a 50% reduction in pain within two months. The therapy uses electrical signals to trick the brain into feeling less pain. Research suggests these signals help change how the brain perceives pain, making it more manageable. Multiple trials, especially for conditions like pancreatic pain, have supported these promising outcomes. ^{1 2 3 4 6}

Who Is on the Research Team?

Mahya Faghih

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

Adults with chronic pancreatitis who suffer from persistent abdominal pain that hasn't improved with standard treatments are eligible for this trial. The study aims to gather initial data on the effectiveness of Scrambler Therapy.

Inclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 5-10 daily Scrambler Therapy sessions lasting 30-40 minutes each

1-2 weeks

5-10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with weekly pain ratings and standardized questionnaires at 3 months

3 months

Weekly check-ins (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Scrambler Therapy

Trial Overview Scrambler Therapy, a non-invasive device approved by the FDA, is being tested for its ability to alleviate pain in patients with chronic pancreatitis. Participants will receive 5-10 treatment sessions and be monitored over three months using pain scores and quality-of-life measures.

How Is the Trial Designed?

Group I: Scrambler Therapy for Chronic Pancreatitis Pain Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

The National Pancreas Foundation

Collaborator

Trials

5

Recruited

680+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07174609

NCT07174609 | Scrambler Therapy in Chronic Pancreatitis This is a single-arm, observational pilot study to test whether Scrambler Therapy (ST) is a feasible and effective treatment for refractory ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6482660/

Inside the Scrambler Therapy, a Noninvasive Treatment of ... The success rate, defined as pain relief of more than 50% was reached in 80% of cases at approximately the 2-month follow-up visit. No ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03707444

A Pilot Trial of Scrambler Therapy for Pain Associated With ... Preliminary data on Scrambler therapy in pancreas cancer Scrambler Therapy appears to work on pain based on results from multiple trials. In fact, the first ...

4. withpower.com withpower.com/clinical-trials/for-chronic-pancreatitis

Top Chronic Pancreatitis Clinical Trials | Power Scrambler Therapy for Chronic Pancreatitis​​ This study will test the feasibility and effectiveness of Scrambler Therapy, a non-invasive FDA-cleared device that ...

5. painphysicianjournal.com painphysicianjournal.com/current/pdf?article=NzU0OQ%3D%3D&journal=147

Efficacy of Scrambler Therapy for Management of Chronic ... Results: Out of 348 studies, a total of 7 RCTs (n = 287 patients) that met the inclusion criteria were included in the final analysis.

6. intechopen.com intechopen.com/chapters/87287

Scrambler Therapy in Acute and Chronic Pain: A Review Scrambler therapy utilizes a device and technique that delivers a non-invasive electro-analgesic treatment regimen to patients in pain, both acute and chronic.