Startle Adjuvant Rehabilitation Therapy (START) for Stroke

Phase-Based Estimates
1
Effectiveness
1
Safety
Arizona State University, Tempe, AZ
Stroke+3 More
Startle Adjuvant Rehabilitation Therapy (START) - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Stroke

Study Summary

This study is evaluating whether a new therapy may help individuals with stroke.

See full description

Eligible Conditions

  • Stroke
  • Apraxias
  • Aphasia
  • Apraxia of Speech

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Startle Adjuvant Rehabilitation Therapy (START) will improve 6 primary outcomes in patients with Stroke. Measurement will happen over the course of end of training.

Baseline, end of training, one-month post
Stroke Impact Scale
end of training
Apraxia Battery for adults
Western Aphasia Battery
one month post
Western Aphasia Battery Retention
one-month post
Apraxia Battery for adults Retention
Stroke Impact Scale Retention

Trial Safety

Trial Design

2 Treatment Groups

Control
START

This trial requires 54 total participants across 2 different treatment groups

This trial involves 2 different treatments. Startle Adjuvant Rehabilitation Therapy (START) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

START
Behavioral
START (startle adjuvant rehabilitation therapy) will be applied.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

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

Who is running the study

Principal Investigator
C. H.
Prof. Claire Honeycutt, Assistant Professor
Arizona State University

Closest Location

Arizona State University - Tempe, AZ

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:
18 years old
Native English Speakers
Capacity to provide informed consent
Right-handed
Corrected to normal vision
Left hemisphere cerebral stroke at least 6 months prior to testing
Presence of severe-to-moderate, non-fluent aphasia, i.e. Aphasia Quotients of 0-50 on the Western Aphasia Battery-Revised (PsychCorp, 2007)
Corrected pure tone threshold (octave frequencies 250- 4000 Hz) norms for their age and gender41,42 NOTE: Audiometry data will be collected for all participants by lab personnel trained by an audiologist in a sound-attenuated booth. Based on our ongoing aphasia studies, we expect that ~30% of participants will use hearing aids; we will not exclude these individuals but rather include hearing aid use as a covariate in analyses.

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 stroke?

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Stroke is a complex problem, and its presentation is varied. Symptoms of stroke include changes in sensations such as numbness, weakness in the arms or legs, or loss of sensation or taste. These sensations may become worse over time. Weakness is present in one or both arms or legs. Tossing the arms or legs may produce weakness. People with symptoms such as these do not need immediate medical attention. The use of a neurology examination may help confirm a diagnosis.

Unverified Answer

What is stroke?

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Stroke is a neurological disorder that causes disruptions in the brain and impair functional abilities. For about two thirds of a million stroke cases, the exact cause of the disorder is unknown. The main risk factors for stroke are high blood pressure, smoking and Diabetes mellitus. This article gives a brief overview of the main symptoms and risk factors.

Unverified Answer

What are common treatments for stroke?

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A variety of treatments are available to manage or improve a patient's condition after a stroke. These may be targeted to the individual's needs. The National Institute for Health Stroke Scale may be valuable for selecting treatment for individuals after a stroke. The scale allows stroke clinicians to compare the efficiency of different treatment choices for the stroke patient.

Unverified Answer

Can stroke be cured?

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If the time from onset to surgery is short, there are good chances that an acute thrombotic stroke can be cured with reasonable chances of good functional outcome; however, if the time from onset to surgery is long, a large and potentially life-threatening hemorrhagic stroke is unlikely to be cured.

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

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Approximately 25,000 people in the United States will have a stroke each year. This contributes to 15% of all strokes seen by family physicians in the United States. Stroke in children is the most common manifestation in the first decade of life.

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What causes stroke?

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Stroke is common. Risk factors and stroke can be predicted and modified. Stroke patients can be effectively treated using existing therapies. Stroke care is an evolving profession.

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Have there been any new discoveries for treating stroke?

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A new drug, efalizumab is now in human clinical trials, with promising preliminary evidence, to help in the short term recovery of walking in adult stroke patients. Eralizumab reduces swelling, relieving pressure on the brain for 6 days prior to and after the stroke event. It is now being evaluated in clinical trials, either alone, in combination with corticosteroids or with anti-inflammatory agents. Trials could take many years to complete and the effects of efalizumab may be subtle because the dose has to be carefully controlled to minimize side effects such as nausea and bronchospasm.

Unverified Answer

Is startle adjuvant rehabilitation therapy (start) safe for people?

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Despite anecdotal reports of people responding to startle treatment, our research demonstrates that the effectiveness of treatment is not supported by this finding. It will be imperative to determine if the treatment can lead to any measurable change in the participants' outcomes.

Unverified Answer

How does startle adjuvant rehabilitation therapy (start) work?

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The rehabilitation therapy performed for 4 weeks by a clinician after a brain insult was less effective for patients with non-hemispatialized stroke than that for patients with hemispheric strokes. The noninvasive rehabilitation therapy performed by clinicians might be a more effective method. This treatment may be considered an effective adjuvant rehabilitation therapy.

Unverified Answer

What is the average age someone gets stroke?

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About 50 years of age is the average age when a person with acute stroke suffers his or her first stroke. As our population ages, the incidence of stroke will increase. Therefore, preventive campaigns must be given more attention for those people who are about to have this common risk factor\n

Unverified Answer

What does startle adjuvant rehabilitation therapy (start) usually treat?

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Startle adjuvant rehabilitation therapy is probably not as effective as claimed but may improve or change behaviour and thus reduce risk of subsequent falls in older adults.

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What is the latest research for stroke?

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This review concludes that there is a large and growing number of randomized, controlled trials assessing thrombolytic interventions, and that an improved standard of care is probably achievable.

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