Scrambler Therapy for Peripheral Neuropathy

Overseen By Leslie Fortin, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Fox Chase Cancer Center

Must be taking: Duloxetine

Must not be taking: MAOIs, Gabapentin

Disqualifiers: Children, Pregnant, Severe depression, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

The investigators hypothesize that Scrambler therapy with duloxetine, compared to duloxetine-based usual care, will result in greater improvement in CIPN as measured by the BPI-Short Form. In addition, the investigators will further assess pain using the EORTC CIPN-20 and determine whether Scrambler therapy results in improved levels of function as measured with the PDQ, and a decreased need for opioid medications. Our primary objective is to investigate whether Scrambler therapy with duloxetine is superior to duloxetine-based usual care in achieving at least a 50% reduction in pain scores, when comparing the cross-sectionally measured "average" pain score at day 35 to the cross-sectionally measured "average" pain score at baseline.

Will I have to stop taking my current medications?

The trial requires that you be on duloxetine for at least 4 weeks before starting. If you are taking gabapentin, you must be able to stop it, as the trial requires tapering off gabapentin. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

Is Scrambler Therapy safe for treating peripheral neuropathy?

Preliminary studies suggest that Scrambler Therapy, a noninvasive treatment using electrical stimulation, is generally safe for treating chemotherapy-induced peripheral neuropathy in both adults and adolescents. ^{1 2 3 4 5}

How does Scrambler Therapy differ from other treatments for peripheral neuropathy?

Scrambler Therapy is unique because it uses electrical stimulation to 'retrain' the brain to interpret pain signals differently, unlike other treatments that often focus on managing symptoms with medication. This non-invasive approach aims to provide relief by altering the way pain is perceived, rather than just masking it. ^{6 7 8 9 10}

Research Team

Marcin Chwistek, MD

Principal Investigator

Fox Chase Cancer Center

Eligibility Criteria

This trial is for individuals experiencing pain due to chemotherapy-induced peripheral neuropathy (CIPN). Participants should be currently receiving or have completed chemotherapy. They must not have other medical conditions that could interfere with the study or be using certain medications that affect CIPN assessment.

Inclusion Criteria

At least CTCAE version 5.0 grade 2 neuropathies

I can perform all my daily activities without help.

Score of at least 4 on the Douleur-Neuropathique-en-4 Questions (DN4) questionnaire

Exclusion Criteria

Patients with severe depression, suicidal ideation, bipolar disease, alcohol abuse, a major eating disorder

I have epilepsy that is not well-controlled.

Pregnant or nursing patients

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Scrambler therapy with duloxetine or duloxetine-based usual care

8 weeks

Weekly visits for therapy sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Scrambler Therapy

Trial Overview The study tests if Scrambler therapy combined with duloxetine results in better pain relief for CIPN than just duloxetine-based usual care. Pain reduction is measured by questionnaires and physical exams, focusing on whether patients achieve at least a 50% drop in pain scores after treatment.

Participant Groups

Group I: Duloxetine Group Experimental Treatment 1 Intervention

Patients will be treated with Duloxetine as per Specialized Outpatient Palliative Care SOPC standard neuropathy treatment protocol

Group II: Scrambler + Duloxetine Active Control 2 Interventions

Patients' pharmacological treatment of their CIPN (including the management of duloxetine and other co-analgesics) will follow SOPC standard neuropathy treatment protocol

Who Is Running the Clinical Trial?

Fox Chase Cancer Center

Lead Sponsor

Trials

236

Recruited

39,300+

Findings from Research

Scrambler therapy (ST) significantly reduced pain levels in adolescents with chemotherapy-induced peripheral neuropathy (CIPN), with pain scores dropping from an average of 9.22 to 0.11 after treatment, indicating strong efficacy.

The therapy also improved quality of life across multiple areas, including general activity, mood, walking ability, sleep, and social relationships, with no reported side effects, suggesting it is a safe and effective option for managing CIPN in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scrambler therapy efficacy and safety for neuropathic pain correlated with chemotherapy-induced peripheral neuropathy in adolescents: A preliminary study. Tomasello, C., Pinto, RM., Mennini, C., et al.[2019]

Scrambler therapy (ST) is a promising noninvasive treatment for chronic neuropathic and cancer pain, utilizing artificial neurons to transmit 'non-pain' signals through C fiber receptors.

In three case studies of patients suffering from chemotherapy-induced peripheral neuropathy, scrambler therapy demonstrated successful pain relief, highlighting its potential as an alternative when traditional pain management methods are ineffective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scrambler therapy: A ray of hope for refractory chemotherapy-induced peripheral neuropathy. Ahuja, D., Bharati, SJ., Gupta, N., et al.[2020]

Diabetic neuropathy significantly impacts patients' quality of life and is linked to serious complications like foot ulcers and increased mortality, highlighting the need for effective drug treatments.

Randomized clinical trials (RCTs) evaluating treatments for diabetic neuropathy have historically been of poor quality, emphasizing the importance of well-designed studies that consider factors like neuropathy stage, outcome measures, and long-term effects to ensure meaningful results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical trials for drugs against diabetic neuropathy: can we combine scientific needs with clinical practicalities? Ziegler, D., Luft, D.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Pilot Randomized Sham-Controlled Trial of MC5-A Scrambler Therapy in the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy (CIPN). [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Scrambler therapy efficacy and safety for neuropathic pain correlated with chemotherapy-induced peripheral neuropathy in adolescents: A preliminary study. [2019]

3. India pubmed.ncbi.nlm.nih.gov

Scrambler therapy: A ray of hope for refractory chemotherapy-induced peripheral neuropathy. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

Scrambler therapy for chemotherapy neuropathy: a randomized phase II pilot trial. [2020]

5. Germany pubmed.ncbi.nlm.nih.gov

Pilot evaluation of Scrambler therapy for the treatment of chemotherapy-induced peripheral neuropathy. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Clinical trials for drugs against diabetic neuropathy: can we combine scientific needs with clinical practicalities? [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Approaches to improve epidemiological studies of diabetic neuropathy: insights from the Rochester Diabetic Neuropathy Study. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Challenges in developing novel therapies for peripheral neuropathies: a summary of The Foundation for Peripheral Neuropathy Scientific Symposium 2012. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

The effects of dry needling and neurodynamic exercise on idiopathic peripheral neuropathy: A case report. [2020]

10. England pubmed.ncbi.nlm.nih.gov

The therapeutic potential of gene transfer for the treatment of peripheral neuropathies. [2012]