What side effects are associated with this type of intervention?

Common treatments for post-stroke pain that use electrical stimulation to interfere with pain signal transmission, such as Scrambler Therapy, typically have mild and temporary side effects. These can include skin irritation at the electrode site, muscle twitching, discomfort during treatment, headaches, and dizziness. Allergic reactions to adhesive materials used in the therapy are also possible but rare.

What prior FDA approvals exist?

There is no specific mention of FDA-approved treatments for post-stroke pain that are similar to Scrambler Therapy in the provided context. However, Scrambler Therapy itself is an emerging treatment approach that uses electrical stimulation to interfere with pain signal transmission. This method is being studied for its effectiveness compared to traditional pharmacologic therapies. Other FDA-approved treatments for chronic pain conditions, such as spinal cord stimulation, may also be relevant, but specific approvals for post-stroke pain are not detailed in the context.

What other types of research exist?

Promising alternatives to Scrambler Therapy for post-stroke pain patients include: 1) Transcutaneous Electrical Nerve Stimulation (TENS), which provides symptomatic relief by modifying pain perception through surface electrodes. 2) Percutaneous Electrical Nerve Stimulation (PENS), which involves inserting needles into soft tissue to apply low-level electrical stimulation targeting dermatomal levels. 3) Spinal Cord Stimulation (SCS), which involves implanting a device to deliver electrical pulses to the spinal cord, effectively managing chronic pain. 4) Transcranial Magnetic Stimulation (TMS), which uses magnetic fields to stimulate nerve cells in the brain, showing promise in pain reduction. These alternatives offer varying degrees of efficacy and safety, and their suitability should be discussed with a healthcare provider.

← Back to Search

Behavioural Intervention

Scrambler Therapy for Post-Stroke Pain

Phase 4

Recruiting

Led By Dawn Merbach, MNP

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 over the age of 18 with ischemic or hemorrhagic stroke seen on imaging and a positive finding for pain in the area(s) affected by their stroke location

Be older than 18 years old

Must not have

Patients with TIA

Patients with uncontrolled epilepsy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is comparing Scrambler Therapy, which uses electrical signals to reduce pain, with traditional pain medications in stroke patients who have ongoing pain. The goal is to see which method provides better and longer-lasting pain relief. Scrambler Therapy is a non-invasive treatment developed to manage chronic neuropathic and cancer pain by substituting pain signals with synthetic 'non-pain' information.

Who is the study for?

This trial is for adults over 18 who've had a stroke at least one month ago and are now experiencing pain due to the stroke. They must have evidence of ischemic or hemorrhagic stroke on imaging with related pain. People with transient ischemic attacks, no MRI evidence of stroke, implanted devices like pacemakers, recent heart attacks, uncontrolled epilepsy, or brain metastases can't join.

What is being tested?

The study compares Scrambler Therapy—a device aiming to 'scramble' pain signals—with standard medication management for post-stroke pain relief. Participants will be assigned to receive either this new therapy or continue with their usual drug treatments.

What are the potential side effects?

Scrambler Therapy may cause skin irritation where pads are placed and temporary discomfort during treatment sessions. Standard medications' side effects vary based on the drugs used but often include drowsiness, nausea, constipation, and potential risk of addiction.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am over 18 and have had a stroke confirmed by imaging, with pain in the affected area.

Exclusion Criteria

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

Select...

I have had a transient ischemic attack (TIA).

Select...

I have epilepsy that is not well-controlled.

Select...

I have brain metastases that are causing symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Pain

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Scrambler Therapy Group 5 sessionsExperimental Treatment1 Intervention

Patients undergoing treatment by Scrambler Therapy will begin by describing the areas and levels of pain along the Numerical Rating Scale (NRS) from 0-10. After the Scrambler treatment, patients will again be asked to describe the areas and levels of pain using the NRS. Each patient undergoing Scrambler Therapy will undergo this process for 5 consecutive days, following the same procedure every day of treatment. After completion of treatment, participants will be asked to complete monthly ratings of their pain for three months, and to follow-up in clinic at 3-6 month intervals (standard of care).

Group II: Scrambler Therapy Group 10 sessionsActive Control1 Intervention

Patients undergoing treatment by Scrambler Therapy will begin by describing the areas and levels of pain along the Numerical Rating Scale (NRS) from 0-10. After the Scrambler treatment, patients will again be asked to describe the areas and levels of pain using the NRS. Each patient undergoing Scrambler Therapy will undergo this process for 10 consecutive days, following the same procedure every day of treatment. After completion of treatment, participants will be asked to complete monthly ratings of their pain for three months, and to follow-up in clinic at 3-6 month intervals (standard of care).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Scrambler Therapy

2015

N/A

~40

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

Post-stroke pain treatments often involve electrical stimulation techniques such as Scrambler Therapy, Transcutaneous Electrical Nerve Stimulation (TENS), and Spinal Cord Stimulation (SCS). These methods work by interfering with pain signal transmission to the brain. Scrambler Therapy uses electrical signals to 'scramble' pain signals, effectively reprogramming the brain's perception of pain. TENS delivers low-voltage electrical currents through the skin to disrupt pain signals and stimulate the production of endorphins, the body's natural painkillers. SCS involves implanting a device that sends electrical pulses to the spinal cord, blocking pain signals before they reach the brain. These treatments are crucial for post-stroke pain patients as they offer non-pharmacological options to manage chronic pain, potentially reducing reliance on medications and their associated side effects.

Scrambler therapy for noncancer neuropathic pain: a focused review.