Low Intensity Focused Ultrasonic Stimulation for Stroke

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Duke University Hospital, Durham, NC
Stroke
Low Intensity Focused Ultrasonic Stimulation - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether low intensity focused ultrasound is safe and tolerable in people who have had a stroke.

See full description

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Low Intensity Focused Ultrasonic Stimulation will improve 2 primary outcomes in patients with Stroke. Measurement will happen over the course of Immediately after ultrasonic stimulation.

At any point during or immediately following intervention on day of LIFUS application
Safety Outcomes, as measured by the number of participants with a "major response" - Aim 1 of study
Immediately after ultrasonic stimulation
Cortical Excitability - Aim 2 of the study

Trial Safety

Trial Design

1 Treatment Group

Low Intensity Focused Ultrasonic Stimulation
1 of 1
Experimental Treatment

This trial requires 90 total participants across 1 different treatment group

This trial involves a single treatment. Low Intensity Focused Ultrasonic Stimulation 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.

Low Intensity Focused Ultrasonic StimulationThere are different combinations of intensity and frequency with LIFUS

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at any point during or immediately following intervention on day of lifus application
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly at any point during or immediately following intervention on day of lifus application for reporting.

Closest Location

Duke University Hospital - Durham, NC

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
≥ 21 years old of any gender and race;
Clinical ischemic stroke (confirmed by CT or MRI) that occurred > 2 months ago;
Predominantly unilateral motor impairment with FM-UE score ≤ 62/66;
MEPs are inducible from a hand muscle on the affected side (i.e. Abductor Pollicis Brevis (APB) muscle).

Patient Q&A Section

What are common treatments for stroke?

"These data show that the treatments of stroke survivors vary widely according to the severity of stroke and their individual presentation at diagnosis. The use of prophylactic antiplatelet agents in stroke survivors of moderate to high risk is not common. Low-surgical-risk strokes have a substantial prevalence of pCVA, and revascularization of the affected hemisphere is necessary for these patients. The incidence of mild strokes in elderly subjects is also high and the use of antiplatelet agents is not uncommon." - Anonymous Online Contributor

Unverified Answer

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

"Around 5 million (95% CI 1.83-11.9 million) out of the US civilian population are at risk of ischemic stroke every year. Stroke is the second most common cause of death in US citizens after heart disease." - Anonymous Online Contributor

Unverified Answer

What is stroke?

"Stroke is a medical condition caused by a blocked blood vessel either in or in the brain. It can occur at any age and can be an emergency condition. About 5 million people in the USA have a stroke each year. Stroke occurs when blood collects in a blood vessel with a weakened or blocked lining; the weak part ruptures or tears.\n" - Anonymous Online Contributor

Unverified Answer

What causes stroke?

"Most stroke has at least several causes, including hypertension, high cholesterol, heart disease, diabetes, atrial fibrillation, cigarette smoking, and cerebral venous thrombosis. Strokes of different vascular etiology may have different risk factors. Stroke prevention must be based on the specific risk factors of the stroke." - Anonymous Online Contributor

Unverified Answer

Can stroke be cured?

"There is no conclusive evidence with which to make any final statement on treatment for stroke or the effects on the stroke. There is insufficient evidence that one drug or set of drugs is better than another for treating the effects of stroke and the amount of rehabilitation needed. Only by randomized controlled trials is a strong evidence base to be generated. A randomised blinded controlled trial is required to ascertain the effects of thrombolysis or tissue plasminogen activator." - Anonymous Online Contributor

Unverified Answer

What are the signs of stroke?

"The three most commons signs of stroke are headache, dizziness, and weakness of one or both sides of the body. Weakness in both arms can also be a sign of stroke. Stroke may cause temporary loss of ability to hear or speak (audiology), a sudden and painful limb weakness (neurology), blurred vision, double vision, or ringing in the ears (vestibular system). Stroke can also cause other neurologic signs such as memory problems (neuropsychology), difficulties with the eyes (oculoptyology), and loss of movement function with the eyelid (paraesthesiology)." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of low intensity focused ultrasonic stimulation?

"Subjects who received ultrasound therapy for a 3-week period experienced significant decrease in the percentage of subjects reporting the presence of pain or tenderness during the application of laser beam. Overall, the application of low-intensity focused ultrasound to the sciatic nerve produced no significant side effects." - Anonymous Online Contributor

Unverified Answer

Is low intensity focused ultrasonic stimulation safe for people?

"Low intensity focused ultrasound is safe for patients with normal or normalising renal function when the therapy is delivered for 3 sessions over five minutes on a five day-a week basis. It is not associated with any pain or distress." - Anonymous Online Contributor

Unverified Answer

What is the latest research for stroke?

"The most recent research suggests that patients with diabetes and cardiovascular disease, as well as smokers and patients with a history of an ischemic stroke are unlikely to derive benefit from statin therapy." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating stroke?

"We can add more research on the role of antioxidants in preventing stroke. One of the ways we did this is through the use of intravenous iron. Oral antioxidants have also been found to prove to be effective for preventing stroke. Furthermore, we found that patients undergoing stents were less likely to develop stroke compared to the control group. For people who are experiencing stroke, blood thinners are useful in reducing the risk of stroke. Furthermore, we have found that antiplatelets can reduce the risk of new strokes." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets stroke?

"The average age of stroke is 62 years. The age range is 48–84 years. About half the time, it lasts from few minutes up to 3 hours in hospitalized patients, and about 75% of strokes are ischemic stroke. Stroke is not a rare disease, even in our country. We need to improve stroke awareness, and more research in stroke epidemiology is needed in our country to detect stroke early." - Anonymous Online Contributor

Unverified Answer

Does low intensity focused ultrasonic stimulation improve quality of life for those with stroke?

"The data of this pilot study show that chronic pain and/or fatigue due to post-stroke stroke can have a significant impact on the lifestyle of those who are affected and negatively affects their quality of life." - Anonymous Online Contributor

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