Scrambler Therapy for Post-Stroke Pain

Overseen By Erin Lawrence, MSN

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Johns Hopkins University

Disqualifiers: TIA, No stroke on MRI, Implantable devices, Myocardial infarction, Uncontrolled epilepsy, Brain metastases

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 1-2 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of Scrambler Therapy for treating post-stroke pain?

Scrambler Therapy has shown effectiveness in reducing chronic neuropathic and cancer pain by replacing pain signals with 'non-pain' information, leading to significant pain relief in other conditions. This suggests potential benefits for post-stroke pain as well. ^{1 2 3 4 5}

Is Scrambler Therapy safe for humans?

Scrambler Therapy is generally considered safe for humans, as it is a non-invasive treatment that has received clearance from the United States Food and Drug Administration for treating various types of pain, including acute, postoperative, and chronic pain. ^{1 2 3 4 6}

How is Scrambler Therapy different from other treatments for post-stroke pain?

Scrambler Therapy is unique because it is a non-invasive treatment that uses electrical signals to replace pain signals with 'non-pain' information, unlike traditional methods that block nerve signals. It aims to provide long-lasting pain relief after a series of sessions, making it different from standard pain treatments that often rely on medications. ^{1 2 3 4 7}

Research Team

Dawn Merbach, MNP

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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.

Inclusion Criteria

I had a stroke more than a month ago.

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

Exclusion Criteria

I had a heart attack in the last 6 months.

I have had a transient ischemic attack (TIA).

You have a pacemaker, defibrillator, or spinal cord stimulator implanted in your body.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Scrambler Therapy for 5-10 sessions or undergo pharmacological treatment

1-2 weeks

5-10 visits (in-person)

Follow-up

Participants are monitored for pain control with monthly ratings and clinic follow-ups at 3-6 month intervals

12 months

Monthly ratings, clinic visits every 3-6 months

Treatment Details

Interventions

• Scrambler Therapy

Trial Overview 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.

Participant Groups

Group I: Scrambler Therapy Group 5 sessions Experimental Treatment 1 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 sessions Active Control 1 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).

Scrambler Therapy is already approved in United States, European Union for the following indications:

Approved in United States as Calmare MC5-A Scrambler Therapy for:

• Chronic neuropathic pain
• Oncologic pain
• Chemotherapy-induced peripheral neuropathy

Approved in European Union as Calmare MC5-A Scrambler Therapy for:

• Chronic neuropathic pain
• Oncologic pain

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Findings from Research

Calmare (Scrambler) therapy showed a 38.1% success rate in providing at least 50% pain relief for patients with various pain conditions, particularly benefiting those with neuropathic or mixed pain types.

Factors such as the treatment site and the type of pain significantly influenced outcomes, suggesting that specific patient characteristics should be considered when selecting candidates for Calmare therapy in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictive factors associated with success and failure for Calmare (Scrambler) therapy: a multicenter analysis. Moon, JY., Kurihara, C., Beckles, JP., et al.[2015]

Scrambler Therapy (ST) is a noninvasive treatment for chronic neuropathic and cancer pain that uses a novel mechanism involving the transmission of synthetic 'non-pain' information through C fiber receptors, differing from traditional pain relief methods like TENS.

The therapy aims to provide immediate pain relief and long-lasting analgesia after a series of 10 to 12 treatments over two weeks, specifically targeting patients who do not respond well to opioids and other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inside the Scrambler Therapy, a Noninvasive Treatment of Chronic Neuropathic and Cancer Pain: From the Gate Control Theory to the Active Principle of Information. Marineo, G.[2023]

Scrambler therapy (ST) is a safe and well-tolerated noninvasive treatment for chronic pain, particularly effective for neuropathic pain conditions like chemotherapy-induced peripheral neuropathy, based on a systematic review of 21 studies.

The therapy not only provides significant pain relief but may also lead to secondary benefits such as reduced medication use and improved sensory and motor symptoms, although more extensive studies are needed to confirm its efficacy in nociceptive pain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Scrambler Therapy in Treating Chronic Pain Syndromes: A Systematic Review. Karri, J., Marathe, A., Smith, TJ., et al.[2023]

Scrambler Therapy significantly reduced chronic pain in 201 patients, with average pain scores dropping from 7.41 to 1.60 after ten treatment sessions, indicating its efficacy in managing refractory neuropathic pain.

The therapy was found to be safe, with only 7 patients discontinuing due to lack of results and very few adverse events reported, suggesting it is a viable non-invasive option for chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic pain treatment and scrambler therapy: a multicenter retrospective analysis. Compagnone, C., Tagliaferri, F.[2016]

Scrambler therapy significantly reduced pain levels in patients with chronic neuropathic pain, showing a 15% decrease in pain scores over 2 weeks, indicating its efficacy as a noninvasive treatment option.

The effectiveness of scrambler therapy varied based on the type of neuropathic pain, with better outcomes observed in patients experiencing paroxysmal pain compared to those with persistent pain, suggesting that understanding pain phenotypes could enhance treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differential response to scrambler therapy by neuropathic pain phenotypes. Min, YG., Baek, HS., Lee, KM., et al.[2021]

Calmare Scrambler Therapy (ST) did not show statistically significant differences in reducing chronic neuropathic pain or improving quality of life compared to sham treatment in a study of 47 military service members.

Despite the lack of measurable efficacy, both active and sham treatments resulted in clinically meaningful pain reductions, and 90% of participants perceived the treatment as a success, highlighting the importance of patient perceptions in chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scrambler Therapy Treatment: The Importance of Examining Clinically Meaningful Improvements in Chronic Pain and Quality of Life. Nayback-Beebe, A., Panula, T., Arzola, S., et al.[2020]

In a case series of 25 patients with cancer pain from skeletal and visceral metastases, scrambler therapy resulted in a significant pain reduction, with all patients experiencing at least 50% relief and an average pain score dropping from 8.4 to 2.9 after treatment.

Scrambler therapy was well-tolerated with no adverse events reported, and it allowed for a reduction in opioid dosage, suggesting it could be a safe and effective alternative for managing cancer pain after standard treatments have failed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot evaluation of scrambler therapy for pain induced by bone and visceral metastases and refractory to standard therapies. Notaro, P., Dell'Agnola, CA., Dell'Agnola, AJ., et al.[2018]

References

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

Predictive factors associated with success and failure for Calmare (Scrambler) therapy: a multicenter analysis. [2015]

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

Inside the Scrambler Therapy, a Noninvasive Treatment of Chronic Neuropathic and Cancer Pain: From the Gate Control Theory to the Active Principle of Information. [2023]

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

The Use of Scrambler Therapy in Treating Chronic Pain Syndromes: A Systematic Review. [2023]

4. Italy pubmed.ncbi.nlm.nih.gov

Chronic pain treatment and scrambler therapy: a multicenter retrospective analysis. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Differential response to scrambler therapy by neuropathic pain phenotypes. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Scrambler Therapy Treatment: The Importance of Examining Clinically Meaningful Improvements in Chronic Pain and Quality of Life. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

Pilot evaluation of scrambler therapy for pain induced by bone and visceral metastases and refractory to standard therapies. [2018]