Non-invasive electromagnetic stimulation for acute stroke treatment for Wake-up Stroke

Phase-Based Estimates
1
Effectiveness
1
Safety
MetroHealth, Cleveland, OH
Wake-up Stroke+2 More
Non-invasive electromagnetic stimulation for acute stroke treatment - Device
Eligibility
18+
All Sexes
Eligible conditions
Wake-up Stroke

Study Summary

This study is evaluating whether a device which stimulates blood flow in the brain may help treat stroke.

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Eligible Conditions

  • Wake-up Stroke
  • Ischemic Stroke
  • Stroke
  • Stroke, Acute

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Non-invasive electromagnetic stimulation for acute stroke treatment will improve 2 primary outcomes and 10 secondary outcomes in patients with Wake-up Stroke. Measurement will happen over the course of 1-7 days post-procedure.

1-7 days post-procedure
Feasibility of device use in the Clinical Environment as assessed by User Survey
2-4 hours post-procedure
Exploratory - Rate of change in collateral blood flow as measured by Computed Tomography Perfusion
Exploratory - Rate of change in core volume as measured by Computed Tomography Perfusion
Exploratory - Rate of change in occlusion status as measured by Computed Tomography Perfusion
Exploratory - Rate of change in penumbra volume as measured by Computed Tomography Perfusion
24 hours post-procedure
Exploratory - Change in National Institute of Health Stroke Scale (NIHSS) - 24 hours
Exploratory - Difference in baseline core volume on CTP compared to 24 hour MRI final infarct volume
Exploratory - Final change in infarct growth - CTP (CBF<30%) at pre-stimulation vs MRI-DWI lesion at 24 hours
90 days post-procedure
Exploratory - Patient Outcome as determined by Modified Rankin Scale (mRS)
Exploratory - Patient Outcome as determined by National Institute of Health Stroke Scale (NIHSS)
Rate of device-related adverse events
Pre-procedure, immediately post-procedure, 30, 60, 90, 120, 150, 180, 210, 240 minutes post-procedure
Exploratory - Change in National Institute of Health Stroke Scale (NIHSS) - short-term

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
VItalFlow Stimulation Treatment

This trial requires 10 total participants across 2 different treatment groups

This trial involves 2 different treatments. Non-invasive Electromagnetic Stimulation For Acute Stroke Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

VItalFlow Stimulation Treatment
Device
Enrolled subjects shall receive a VitalFlow stimulation after other standard-of-care treatments are initiated. VitalFlow treatment is initiated by powering on the System and positioning the two (Left and Right) VItalFlow coils on each side of the head (by the ear). The operator controls the VItalFlow Stimulation through the accompanying console with simple button operation. Once treatment is initiated, the VitalFlow provides continuous, biphasic pulses at a preset power cycle with the total treatment time under 5 min (fixed time). After treatment is completed, the coils are removed and replaced on the VitalFlow System.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: pre-procedure, immediately post-procedure, 30, 60, 90, 120, 150, 180, 210, 240 minutes post-procedure
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly pre-procedure, immediately post-procedure, 30, 60, 90, 120, 150, 180, 210, 240 minutes post-procedure for reporting.

Closest Location

MetroHealth - Cleveland, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
If you are not delayed by the study procedures, then you can receive IV rtPA or Endovascular Treatment. show original
The last known normal time was within 4.5 hours of the person's presentation for enrollment. show original
This text allows 1.5 hours for pre-stimulation study procedures so that the therapeutic window remains open for six hours. show original
Ischemic stroke can be difficult to diagnose, particularly in the anterior circulation show original
NIHSS at baseline 4-20
This text states that creatinine levels are below 1.7 mg/dL. show original
for study participation I, _______, hereby give my consent to participate in the study identified as _______ show original
The study looked at the age of 18 to 85 years. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of wake-up stroke?

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Symptoms occur most commonly between the hours following awakening from sleep and the onset of focal brain ischemia. Symptoms tend to be of moderate intensity and are common with many acute strokes. However, symptoms are often delayed for up to 24 hours and, where the onset is gradual, may be missed by many health services who focus on symptoms of stroke.

Unverified Answer

How many people get wake-up stroke a year in the United States?

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At least 80,000 Americans had a nontraumatic wake-up stroke. Wake-up stroke may be more common in females than males. Wake-up stroke has several characteristics that are distinct from stroke in the acute phase of symptom onset.

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Can wake-up stroke be cured?

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Most (55%) patients with wake-up stroke will either recover or have symptomatic lesions that will have to be treated during the subsequent decade. The chance of recurrence is higher, if the etiology is uncertain; however, in the majority of these cases, and with careful and early follow-up, the risk of recurrence is low. Patients with nonarteritic ischemic stroke, the most severe type of cerebral infarction (24%), cannot be treated with curative intent or expect to develop long-lasting neurological deficits. Patients with wake-up stroke are very frequently in the public and are very much aware that they may have a higher chance for recurrence and that treatment should focus on maximizing treatment benefits.

Unverified Answer

What causes wake-up stroke?

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Cerebral hypoperfusion is caused by the mechanism of cardioembolism (especially apical left ventricular outflow tract aortic valve obstruction), and atherosclerosis is a possible cause of cerebral hypoperfusion in this patient group. The clinical features of wake-up stroke suggest that this condition may be underdiagnosed and undertreated.

Unverified Answer

What are common treatments for wake-up stroke?

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Data from a recent study demonstrates that patients with stroke commonly experience pain, insomnia, and fatigue; these may be managed by addressing these concerns and treatment for these symptoms. Medications may be prescribed to manage these symptoms; treatment with aspirin may reduce the likelihood that patients will awaken from a transient ischemic attack (TIA). No specific intervention for sleep disturbances was reported; this recommendation is based on the observations of this analysis.

Unverified Answer

What is wake-up stroke?

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Individuals with WUS have high level of risk factors and present earlier than other ischemic stroke subtypes, including lacunar and lacunar+lacunar. The WUS subtype is characterized by early presentation and a worse prognosis. The incidence of WUS is decreasing, and most patients were previously undiscussed.

Unverified Answer

Does non-invasive electromagnetic stimulation for acute stroke treatment improve quality of life for those with wake-up stroke?

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Stimulation of the sensorimotor cortex can improve quality of life for those with wake-up stroke. Future studies, using a larger number of participants and randomized controlled trials will allow us to determine whether electrostimulation has benefit on stroke recovery.

Unverified Answer

Is non-invasive electromagnetic stimulation for acute stroke treatment typically used in combination with any other treatments?

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A majority of studies of NEMS used in acute stroke rehabilitation were published in the last 5 years. The most frequently used NEMS in stroke rehabilitation was weak stimulation. The most commonly combined treatments were different forms of manual therapy, which is not widely studied.

Unverified Answer

What are the common side effects of non-invasive electromagnetic stimulation for acute stroke treatment?

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The main side effect from ES is headache, which will subside after 3 days. Other common side effects include muscle pain and insomnia. The headache symptoms are controllable and have only transient effects for the majority of patients and therefore do not have a major impact on treatment efficacy. Muscle pain has a long-term and moderate impact on treatment efficacy. Patients and practitioners should be aware of these side effects when they are planning for the long-term effects of ES. These side effects are transient and will go away within a week. Sleep disturbances are relatively troublesome to deal with, but will disappear too once treatment is stopped.

Unverified Answer

What does non-invasive electromagnetic stimulation for acute stroke treatment usually treat?

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Although the current knowledge about non-invasive EES is still limited, most of the current findings about this method of treatment are promising. The possible use of this technology in the treatment of stroke patients is yet to be established. More randomized controlled trials are needed. In addition, there is no consensus in the medical literature about most effective treatment settings, intensities and frequencies of stimulation (see discussion). Overall, it appears that EES may be effective in the treatment of acute stroke, but further controlled, randomized trials comparing different stimulation parameters are required.

Unverified Answer

What are the latest developments in non-invasive electromagnetic stimulation for acute stroke treatment for therapeutic use?

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Data from a recent study shows in-vivo neurorehabilitative potential of eEMG for a wide range of stroke symptoms in patients who are treated immediately after the onset of symptoms.

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How does non-invasive electromagnetic stimulation for acute stroke treatment work?

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Non-invasive EEG EEMS has no apparent effect on neurological outcome. Furthermore, we observed no influence of stimulation on hemorrhagic transformation and stroke size compared with conventional treatment.

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