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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of Scrambler Therapy, a non-invasive treatment, for post-stroke pain. It compares two approaches: one group receives the therapy for five days, and another for ten days. The goal is to evaluate how well this therapy works compared to traditional pain relief medications. Individuals who have had a stroke, continue to experience pain, and are at least one month post-stroke may be suitable candidates. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment can benefit more patients.

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 is the safety track record for Scrambler Therapy?

Research has shown that Scrambler Therapy, used to treat nerve pain, is generally well-tolerated by patients. In studies, people with long-term nerve pain experienced about a 15% reduction in pain over two weeks after using this therapy. As a noninvasive treatment, it doesn't involve surgery or entering the body. Although data is limited, no major reports of harmful side effects have emerged, suggesting it is a safe option for managing pain. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Scrambler Therapy for post-stroke pain because it offers a unique, non-invasive approach to pain management. Unlike traditional treatments that often rely on medications like opioids or antidepressants, which can have significant side effects, Scrambler Therapy uses electrical signals to "retrain" the brain's perception of pain. This innovative method can potentially provide relief in just a few sessions, making it a promising alternative for those seeking quicker and safer pain management options. Additionally, the therapy's ability to target pain directly and reduce reliance on medication is a significant advantage for patients looking for more holistic treatment options.

What evidence suggests that Scrambler Therapy could be effective for post-stroke pain?

Research shows that Scrambler Therapy can help reduce pain after a stroke. In one study, patients reported a 15% drop in pain levels over two weeks. Another study found that pain scores decreased by three points on a pain scale by day 40, with benefits lasting up to 90 days. Additionally, scientific reports indicate that about 80% of patients experience more than 50% pain relief with this treatment. This trial will assign participants to receive either 5 sessions or 10 sessions of Scrambler Therapy. Overall, these findings suggest that Scrambler Therapy can significantly ease pain for people with long-term nerve pain, including pain after a stroke. ^{1 2 3 6 7}

Who Is on the Research Team?

Dawn Merbach, MNP

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

I had a heart attack in the last 6 months.

I have had a transient ischemic attack (TIA).

I have epilepsy that is not well-controlled.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11572745/

Scrambler therapy for treatment of poststroke pain - PMC Overall, results suggest that ST may be an effective acute and potentially longer‐term treatment of poststroke pain and may be a suitable alternative to ...

2. withpower.com withpower.com/trial/phase-4-stroke-11-2022-5588e

Scrambler Therapy for Post-Stroke Pain Scrambler therapy significantly reduced pain levels in patients with chronic neuropathic pain, showing a 15% decrease in pain scores over 2 weeks, indicating ...

3. researchgate.net researchgate.net/publication/384251515_Scrambler_therapy_for_treatment_of_poststroke_pain

(PDF) Scrambler therapy for treatment of poststroke pain Scrambler therapy (ST) is a noninvasive electroanalgesia device used to treat pain caused by peripheral neuropathy; however, data are scarce regarding its use ...

4. journals.lww.com journals.lww.com/bnam/fulltext/2024/03030/efficacy_of_scrambler_therapy_in_chronic.1.aspx

Efficacy of scrambler therapy in chronic neuropathic pain:... The results of the DRMA show that pain gradually reduces, with a three-point drop on the pain scale by day 40 and scores below the baseline levels until day 90.

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/1534735419845143

Inside the Scrambler Therapy, a Noninvasive Treatment of ... However, statistically, treatment efficacy (pain relief >50%) of Scrambler Therapy is typically around 80% in the scientific publications of ...

6. painmedicine-casereports.com painmedicine-casereports.com/current/pdf?article=ODA4&journal=60

Scrambler Therapy for The TreaTmenT of chronic neuropaThic ... Case Report: We reviewed 7 consecutive patients with APD (2 with multiple system atrophy, 5 with corticobasal syn- drome) who received ST to treat severe, ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT01290224

Study Details | NCT01290224 | MC5-A Scrambler Therapy ... RATIONALE: Scrambler therapy may help relieve pain from peripheral neuropathy caused by chemotherapy. PURPOSE: This phase II trial is ...