What is the mechanism of action of this treatment?

Neuropathic pain treatments like Scrambler Therapy (ST) and transcutaneous electrical nerve stimulation (TENS) work by using non-invasive electrical stimulation to modulate pain signal transmission. These therapies aim to disrupt the abnormal pain signals sent to the brain by introducing new, non-painful signals, effectively 'scrambling' the pain messages. This mechanism is crucial for neuropathic pain patients as it offers a non-pharmacologic option to manage pain, potentially reducing reliance on medications and their associated side effects. By altering the way pain is perceived, these treatments can improve quality of life and functional outcomes for patients suffering from chronic neuropathic pain.

What side effects are associated with this type of intervention?

Common treatments for neuropathic pain using neuromodulation through non-invasive electrical stimulation, such as TENS, PENS, and SCS, generally have mild side effects. For TENS, side effects may include skin irritation or redness at the electrode site. PENS can cause minor discomfort or bruising at the needle insertion points. Spinal Cord Stimulation may lead to complications such as infection, lead migration, or hardware malfunction. Overall, these treatments are considered safe with no serious adverse events reported in most studies.

What prior FDA approvals exist?

The FDA has approved several treatments for neuropathic pain that involve neuromodulation through electrical stimulation. One notable example is Spinal Cord Stimulation (SCS), which involves the implantation of a device that sends electrical impulses to the spinal cord to alter pain signal transmission. Another related treatment is Transcutaneous Electrical Nerve Stimulation (TENS), a non-invasive method using surface electrodes to provide symptomatic relief by modifying pain perception. While Scrambler Therapy (ST) itself is still under investigation, these approved treatments share a similar mechanism of action aimed at neuromodulation to manage neuropathic pain.

What other types of research exist?

Promising, novel alternatives to Scrambler Therapy (ST) for neuropathic pain include Transcutaneous Electrical Nerve Stimulation (TENS) and Percutaneous Electrical Nerve Stimulation (PENS). TENS uses a small battery-operated device to provide continuous electrical impulses via surface electrodes, aiming to modify pain perception. PENS involves inserting acupuncture-like needles into soft tissue and applying low-level electrical stimulation, targeting dermatomal levels for treatment. Both methods have shown varying degrees of efficacy in clinical trials and are considered potential alternatives for neuropathic pain management.

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Scrambler Therapy for Neuropathic Pain (ST-CBS Trial)

N/A

Recruiting

Led By Alexander Pantelyat, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

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

Must have

Men and women, ≥50 years of age with CBS and an average daily pain rating of > 4 out of 10 using the Brief Pain Inventory

Ability to understand the study regimen, its requirements, risks, and discomforts, and willingness to sign an informed consent form

Must not have

Skin conditions such as open sores that would prevent proper application of the electrodes

History of epilepsy, brain damage, or symptomatic brain metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 0 to day 30 and 90

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if Scrambler Therapy can reduce pain in patients with corticobasal syndrome. The therapy uses electrical signals to trick the brain into feeling non-painful sensations instead of pain. The goal is to see if this treatment can lower pain levels significantly over a short period. Scrambler Therapy is a noninvasive technique that substitutes pain information with non-painful sensations.

Who is the study for?

This trial is for English-speaking men and women over 50 with corticobasal syndrome (CBS) who experience daily pain above a moderate level. They must understand the study, agree to participate, and have a life expectancy of more than 90 days. It's not for pregnant or nursing women, those with certain metal implants, heart conditions, epilepsy, skin issues affecting electrode placement, or anyone using investigational pain agents recently.

What is being tested?

The trial is testing scrambler therapy (ST), comparing it to transcutaneous electrical nerve stimulation (TENS) for treating neuropathic pain in CBS patients. Participants will be randomly assigned to receive either ST or TENS first; all will eventually get ST. The treatment involves placing ECG electrodes on painful areas for up to 40 minutes.

What are the potential side effects?

While specific side effects are not listed here, typical risks may include discomfort at the electrode application site and potential skin irritation from the adhesive used in both TENS and ST treatments.

Eligibility Criteria

Inclusion Criteria

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

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I am 50 or older with chronic back pain, averaging more than 4 out of 10.

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I understand the study's demands and risks and am willing to consent.

Exclusion Criteria

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

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I do not have open sores that would interfere with using electrodes.

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I have a history of epilepsy, brain damage, or brain cancer spread.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 0 to day 30 and 90

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 0 to day 30 and 90

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 to day 30 and 90 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in patient-reported average daily pain using the Modified Brief Pain Index

Secondary study objectives

Change in patient-reported Global Impression of Change (PGIC)

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

Active Control

Group I: Scrambler therapyExperimental Treatment1 Intervention

Scrambler Therapy is a non-invasive neuromodulation approach using superficial electrocardiogram (ECG) electrodes in paired channels on the involved dermatomes to send "non-pain" information along the existing nerve pathways, which can modify peripheral and central sensitization.

Group II: TENS treatmentActive Control1 Intervention

Transcutaneous electrical nerve stimulation (TENS) is a battery-powered device which delivers low-voltage electrical current through superficial electrocardiogram (ECG) electrodes placed on the surface of the skin to provide pain relief.

0 / 4Eligibility 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

Neuropathic pain treatments like Scrambler Therapy (ST) and transcutaneous electrical nerve stimulation (TENS) work by using non-invasive electrical stimulation to modulate pain signal transmission. These therapies aim to disrupt the abnormal pain signals sent to the brain by introducing new, non-painful signals, effectively 'scrambling' the pain messages. This mechanism is crucial for neuropathic pain patients as it offers a non-pharmacologic option to manage pain, potentially reducing reliance on medications and their associated side effects. By altering the way pain is perceived, these treatments can improve quality of life and functional outcomes for patients suffering from chronic neuropathic pain.