New FINGER for Wake-up Stroke

Phase-Based Estimates
1
Effectiveness
1
Safety
University of California Irvine, Irvine, CA
Wake-up Stroke+3 More
New FINGER - Device
Eligibility
18+
All Sexes
Eligible conditions
Wake-up Stroke

Study Summary

This study is evaluating whether a robot can help improve hand motor function for individuals who have had a stroke.

See full description

Eligible Conditions

  • Wake-up Stroke
  • Ischemic Stroke
  • Stroke
  • Cerebrovascular Accident
  • Stroke, Ischemic

Treatment Effectiveness

Study Objectives

This trial is evaluating whether New FINGER will improve 1 primary outcome and 3 secondary outcomes in patients with Wake-up Stroke. Measurement will happen over the course of From baseline to 1-month post intervention.

From baseline to 1-month post intervention
Box and Blocks Test
Changes in finger proprioception measured using the Crisscross Assessment.
Fugl-Meyer Motor Assessment of the Upper Extremity
Motor Activity Log

Trial Safety

Trial Design

4 Treatment Groups

No Control Group
Group A

This trial requires 60 total participants across 4 different treatment groups

This trial involves 4 different treatments. New FINGER is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Group A
Device
Participants with undergo new FINGER robotic training with no physical assistance 3 times a week for a period of 3 weeks.
Group CParticipants will undergo new FINGER robotic training with physical assistance and proprioceptive exercises 3 times a week for a period of 3 weeks.
Group B
Device
Participants will undergo new FINGER robotic training with physical assistance 3 times a week for a period of 3 weeks.
Group D
Device
Participants with poor finger proprioception will undergo new FINGER robotic training with physical assistance 3 times a week for a period of 3 weeks.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline to 1-month post intervention
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from baseline to 1-month post intervention for reporting.

Who is running the study

Principal Investigator
D. R.
Prof. David Reinkensmeyer, Professor
University of California, Irvine

Closest Location

University of California Irvine - Irvine, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
We are looking for individuals aged 18 to 85 years. show original
Had a stroke that was confirmed by a radiology exam at least 6-months prior to enrollment. show original
(BBT) is a predictor of success on the basketball court An ability to score at least 3 blocks on the Box and Block Test (BBT) is a predictor of success defending the basketball court. 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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The most common early signs of a wake-up stroke appear to be a brief loss of consciousness and sudden weakness in one half of people with a left middle cerebral artery territory of a mild non-hemorrhage. In particular, the most common features in people with a nondisabling left middle cerebral artery infarction are the loss of consciousness and sudden weakness in the paretic arm and sudden weakness and gait incoordination in the opposite leg. In a subgroup of survivors, the presence of a seizure at presentation had a favourable impact on functional recovery.

Unverified Answer

What causes wake-up stroke?

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As the wake-up stroke patient waits to receive treatment for their stroke (or other brain conditions) from their doctor or other health professional they also suffer from fear, panic and depression. It may be useful to encourage patients with a recent transient ischemic attack (TIA) to visit a Stroke Recovery Assistant (SRA) who can administer check-up tests to evaluate TIA symptoms, rule out a TIA with an initial Stroke Assessment to confirm the diagnosis or to assess prognostic factors and tailor appropriate management. The SRA can then provide advice on when to follow up and manage their symptoms. For more information about how to find and recruit a SRA visit https://www.strokerecoveryassistant.

Unverified Answer

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

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Approximately 709,000 people per year will develop a ischemic stroke that occurs within the first 4 hours of waking. The likelihood of developing a stroke increases rapidly with age. Furthermore, for individuals older than 30 years, the risk almost doubles in less than a decade.

Unverified Answer

What is wake-up stroke?

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Data from a recent study showed that the most common symptom in patients suffering from wake-up stroke was headache. All patients who experienced sudden sensorimotor deficit and woke up with headache were found to have a transient ischemic attack. Patients who reported not only headache but also other focal deficits were found to have a possible ischemic stroke. Therefore, patients with a sudden sensorimotor deficit and waking up with a headache should consider being evaluated appropriately for a possible transient ischemic attack or an ischemic stroke.

Unverified Answer

What are common treatments for wake-up stroke?

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[A] few medications for the treatment of wake-up stroke have been studied; they include caffeine, naloxone, and magnesium. For the treatment of stroke, caffeine is typically an alternative first-line treatment and has been shown to be effective in animal models. On a personal basis, it's the treatment of choice for the majority of people who present with a wake-up stroke. There is no evidence to support the use of naloxone or magnesium to treat this condition. Although there is a large body of observational data to support caffeine as an effective and safe intervention for awake stroke patient outcomes, well-designed randomized controlled trials are required to establish the safety and effectiveness of caffeine use for awake stroke patients.

Unverified Answer

Can wake-up stroke be cured?

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Wake-up stroke is a serious, sudden, and unpredictable complication, which has devastating consequences such as long-term functional disability, a poor quality of life, and increased mortality. Treatment with intravenous thrombolysis, surgery, or intensive care, if needed, is urgently essential for patients with ischemic stroke.

Unverified Answer

Who should consider clinical trials for wake-up stroke?

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A sizable proportion of patients treated with standard care would be excluded from clinical trials of wake-up strokes. However, a low number of patients would be eligible for clinical trials based on a very narrow definition of wake-up stroke. These data indicate that patients are eager for this potential benefit.

Unverified Answer

Have there been other clinical trials involving new finger?

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Data from a recent study of this research show that a new finger seems to provide very beneficial outcomes. There were no complications or complications on the patient’s fingers that caused them to have long-term impacts. In general, if a stroke patient is diagnosed with a new finger, it means that he or she will probably have an enhanced or improved chance of recovery. However, if a patient has other complications such as poor blood flow during the surgery time, it could cause them to not complete the therapy and to not complete the procedure. \n\nIf a patient has a condition such as depression, it is necessary for this patient to receive therapy from a mental health care therapist.

Unverified Answer

What is the latest research for wake-up stroke?

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There is significant new information available, but the majority of it on wake-up stroke is old. To help with the decision about treatment, we recommend using [power] (https://www.withpower.com/wake-up-stroke-stroke-science) to identify relevant clinical and trial trials. You may need to contact your local clinical trials liaison teams to request the relevant information for your trial.

Unverified Answer

Is new finger typically used in combination with any other treatments?

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The most typical combination of treatment was aspirin with steroids, and the most common treatment to use on the finger was aspirin and steroids for post-thrombolysis use. The most common regimen was aspirin and steroids for use on the finger.

Unverified Answer

How serious can wake-up stroke be?

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It appears that the likelihood increases of awakening from a coma in a hospital for the first-time patient with a new-onset wake-up stroke, and is more pronounced if the onset is recent (within the past week). These data add to our limited understanding of the early course of wake-up stroke, as we see patients and families not being informed of these potential risks.

Unverified Answer

Does new finger improve quality of life for those with wake-up stroke?

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Improvements were seen on two measures of motor function, but no improvements were found on either measure of quality of life. There was no improvement in the quality of life of individuals with wake-up stroke in this study.

Unverified Answer
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