Scrambler Therapy for Post-Stroke Pain

Study Overview
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Brief Summary
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The Investigators will enroll patients who have had a stroke and are experiencing post-stroke pain secondary to their infarct and disruption of the sensory system in a research study to compare the effectiveness of Scrambler Therapy to traditional pharmacologic therapies.

Detailed Description
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Participants will work with the provider to decide which method of treatment they prefer and will then be followed regularly using standardized pain scores over the next year. Those undergoing ST will undergo 5-10 sessions while those treated with medical therapy will undergo titration of medication as per typical standard of care. The investigators will compare both maximal pain relief achieved and duration achieved between groups. prospectively enroll a consecutive series of patients presenting to clinic with post-stroke pain syndromes following either an ischemic infarct or intracranial hemorrhage. Patients will be included in the study if they are at least one month post-stroke (but can be chronic) and have pain in an area attributable to the location of their lesion (ie contralateral to a lesion involving the thalamus or sensory cortex). At their clinic visit, potential treatments: Scrambler Therapy or pharmacological treatment, will be discussed with each patient. Patients will not be excluded if they are currently taking or have taken pain medications in the past, though these variables will be factored into the analysis. Through shared decision making, the investigator along with the patients input will decide on ST versus medical management. Participants will consent to being followed for pain control over the following year of therapy to enable comparison of ST to standard medical therapy. All patients will begin by rating their current pain on the Numerical Rating Scale (NRS) from 0-10. 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. The dermatomes of the areas of pain will be examined by going up and down the dermatome as shown on a dermatome map, and the electrode of the Scrambler machine will be placed at the site where pain is initiated and approximately 10 centimeters above it. The Scrambler machine will then be started and turned on until patients feel a tingling sensation that is not painful. For approximately 45 minutes, the Scrambler machine will run while a team member watches over the patient, adjusting the levels only if the patient no longer feels the tingling sensation. 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).

Official Title
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Scrambler Therapy for Post-Stroke Pain

Conditions
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Post Stroke Pain

Intervention / Treatment
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* Device: Scrambler Therapy
* Drug: Standard Medication Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 will be included. The patients must be at least one month post-stroke but can otherwise enroll at any point. Exclusion Criteria: Patients with TIA Patients with no evidence of stroke on MRI Patients with implantable devices such as pacemakers, defibrillators, spinal cord stimulators Patients with history of myocardial infarction in the past 6 months Patients with uncontrolled epilepsy Patients with symptomatic brain metastases

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Scrambler Group and Non-scrambler group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Scrambler Therapy Group 5 sessions<br>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). | Device: Scrambler Therapy<br>* Scrambler Therapy is a non-invasive neuromodulator treatment that focuses on relieving chronic pain through the sending of non-pain signals to the brain through the afferent pain sensory nerves. The signals given off by the scrambler therapy machine are intended to mimic neuronal action potentials through the synthesis of 16 unique waveforms that in combination forms a patient specific cutaneous electrostimulation to reduce pain. These information packets are then carried by the afferent C-fibers, an established system that modulates the sensations received instead of blocking them. The modulated signals are received as nonpainful and endogenous by the central nervous system.<br>* Other names: Calmare Therapy;|
| Active Comparator: Scrambler Therapy Group 10 sessions<br>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). | Drug: Standard Medication Management<br>* Medications such as: gabapentin, duloxetine and Lyrica are all FDA approved for treatment of neuropathic pain, particularly that caused by diabetes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in post stroke pain | At least a 50% reduction in post stroke pain | 6 months |