What side effects are associated with this type of intervention?

Common treatments for peripheral neuropathy that use electrical stimulation, such as Transcutaneous Electrical Nerve Stimulation (TENS) and Percutaneous Electrical Nerve Stimulation (PENS), generally have minimal side effects. However, some patients may experience skin irritation or discomfort at the site of electrode placement. In rare cases, there may be a sensation of tingling or lightheadedness. Overall, these treatments are considered safe with few serious adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for peripheral neuropathy, particularly those involving electrical stimulation similar to Scrambler Therapy. One notable example is the use of Transcutaneous Electrical Nerve Stimulation (TENS), which is a non-invasive method that uses low-voltage electrical currents to relieve pain. Additionally, medications such as gabapentin and pregabalin have been approved for neuropathic pain management. These treatments aim to alleviate symptoms by modulating pain signal transmission, similar to the mechanism of Scrambler Therapy.

What other types of research exist?

Promising novel alternatives to Scrambler Therapy for Peripheral Neuropathy patients include: 1) Spinal Cord Stimulation (SCS), which has shown efficacy in managing chronic pain and neuropathy through electrical stimulation of the spinal cord. 2) Noninvasive neuromodulation devices, such as those providing median and radial nerve stimulation, which have demonstrated effectiveness in reducing tremor and may be applicable to neuropathic pain. 3) Biomechanical loading devices, including wearable robots and neuroprostheses, which can modulate muscle activity to reduce pain. These alternatives offer innovative approaches to pain management through various forms of electrical and mechanical stimulation.

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Behavioural Intervention

Scrambler Therapy for Peripheral Neuropathy

N/A

Recruiting

Led By Salahadin Abdi, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients who have CIPN associated with at least moderate symptoms of pain (≥4 on a 0-10 scale) or neuropathy

Patients who have had cancer and are not being actively treated

Must not have

Bone and/or central nervous system metastases that affect gait, walking, and balance

Inability to walk or stand without assistance (need for ambulatory-assist devices)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing Scrambler Therapy, which uses small electrical currents to reduce pain, on adolescents and young adults with cancer who have painful nerve damage from chemotherapy. The therapy works by interfering with pain messages sent to the brain, making the pain feel less intense. Scrambler therapy is a noninvasive treatment for chronic neuropathic and cancer pain that uses synthetic 'non-pain' information transmitted by C fiber surface receptors.

Who is the study for?

This trial is for English-speaking adolescents and young adults aged 15-39 who have had cancer, are not currently in active treatment, and suffer from moderate to severe chemotherapy-induced painful peripheral neuropathy (pain level ≥4). They must be able to complete questionnaires with or without assistance. Those with mobility issues, brain or bone metastases affecting movement, prior Scrambler Therapy, certain implants, epilepsy, skin damage where electrodes would go, or other pain conditions are excluded.

What is being tested?

The study tests the effectiveness of Scrambler Therapy on reducing pain from chemotherapy-induced peripheral neuropathy and improving physical function and quality of life. Participants will be randomly assigned to either receive immediate therapy or placed on a waitlist (control group) in this prospective randomized controlled trial.

What are the potential side effects?

While specific side effects of Scrambler Therapy aren't detailed here, it's generally considered non-invasive with minimal risks. Potential discomfort may arise from electrode placement on the skin depending on individual sensitivity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I experience moderate to severe pain or neuropathy from chemotherapy.

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I had cancer but am not currently receiving treatment.

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I am between 15 and 39 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to my bones or brain, affecting how I walk and balance.

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I need help to walk or stand.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The European Organization for Research and Treatment of Cancer ( EORTC-QLQ C30)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Waitlist ST (Scrambler Therapy)Experimental Treatment1 Intervention

Participant will start ST (Scrambler Therapy) treatment about 4 weeks after your Baseline Visit.

Group II: Immediate St (Scrambler Therapy)Experimental Treatment1 Intervention

Participant will start ST (Scrambler Therapy) treatment right away.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Peripheral neuropathy treatments aim to alleviate pain and improve quality of life by targeting different mechanisms of pain signal transmission. Common treatments include medications like gabapentin and tricyclic antidepressants, which modulate neurotransmitter activity to reduce pain perception. Topical treatments, such as lidocaine patches, provide localized pain relief by blocking sodium channels in nerve cells, thereby inhibiting pain signal transmission. Scrambler Therapy (ST) is an innovative approach that uses electrical stimulation to interfere with pain signal transmission, effectively 'scrambling' the pain messages sent to the brain. This method is particularly relevant for peripheral neuropathy patients as it offers a non-pharmacological option that can reduce reliance on medications and their associated side effects.

The diagnostic workup of patients with neuropathic pain.