S-stream: a multicenter Observational Study to Evaluate the Simplified-stroke rehabilitation Assessment of Movement (s-stream) Scale in Subjects Obtained Between 24 and 48 Hours of a Nonhemorrhagic Ischemic Stroke Objectives

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S-STREAM: A Multicenter Observational Study to Evaluate the Simplified-STroke REhabilitation Assessment of Movement (S-STREAM) Scale in Subjects Obtained Between 24 and 48 Hours of a Nonhemorrhagic Ischemic Stroke

Primary Objectives:

• To ascertain the applicability of the S-STREAM to assess improvement in motor function when obtained between 24 and 48 hours following a mild-to-moderately severe nonhemorrhagic ischemic stroke

• To determine the variability of S-STREAM scores on post stroke Days 1 and 3 and to compare the predictive power of S-STREAM scores on Days 1 and 3 on scores obtained at 3 months

• To determine the variability of the improvement from Day 1 to 3 months in the S-STREAM score in order to estimate the sample size for the planned proof of concept study
Secondary Objective:

• To relate the improvement in motor function over a 3-month period, as assessed by the S-STREAM, to other measures of motor function using the motor scale of the National Institutes of Health Stroke Scale (NIHSS), the Proxy Stroke Impact Scale-16 (Proxy SIS-16), the Short Form-36 Physical Functioning (SF-36 PF) scale, gait speed, and the Clinician’s Global Assessment of Motor Recovery (CGAMR) scale

Exploratory Objective:

• To relate the improvement in motor function over a 3-month period, as assessed by the S-STREAM, to other measures in the trial as indicators of clinically meaningful change

Study Design:

This is a multicenter observational study designed to evaluate the utility of the S-STREAM as an instrument to assess motor function between 24 and 48 hours after the onset of a nonhemorrhagic ischemic stroke. For each subject, observation will begin after informed consent is obtained following the admission of the subject to an acute care emergency center or inpatient facility and may continue to an inpatient facility, rehabilitation center, or via outpatient visits to the study site. This is an observational study and there will be no study drug administered or any other study-mandated therapeutic interventions. Subjects will receive standard of care based on investigator opinion and institutional policy.

Number of Subjects: 120
Inclusion Criteria

Each subject must meet all of the following criteria to participate in this study.

1. Male or female subjects between 21 and 85 years, inclusive

2. Subjects presenting between 24 and 48 hours from onset with an initial diagnosis of first-onset acute stroke with clinical assessments and imaging studies (conducted as standard procedures with stroke patients) indicating that the stroke is ischemic, nonhemorrhagic, in the vascular distribution of the middle cerebral artery, and not classifiable as a lacunar stroke

3. Subjects must understand and agree to comply with the requirements of the study and they must be willing to provide verbal/nonverbal informed consent indicating voluntary consent to participate in the study (if a subject is unable to provide informed consent, but able to comply with other study procedures, the subject’s LAR may provide consent)

4. Subjects must score at least 16 on the Mini Mental Status Examination (MMSE) at screening. If the subject has an expressive aphasia and is unable to qualify based on the MMSE, the subject may be evaluated with a language-modified form of the MMSE17 in conjunction with the investigator’s clinical assessment that the subject is cognitively able to complete study procedures and stroke assessment scales to determine eligibility. If the aphasia is too severe for the subject to complete the language-modified MMSE the subject should be excluded

5. Subjects must have a total score between 20 and 85, inclusive, on the S-STREAM administered between 24 and 48 hours after stroke onset on Day 1 (baseline) to be eligible to continue in this study. This range may be narrowed to include a subset of this population and documented in a note to file
Exclusion Criteria

Subjects who meet any of the following criteria will be excluded from the study.

1. History of previous stroke; uncontrolled severe hypertension; dementia; advanced Parkinson disease or other significant movement disorders; or other clinically significant diseases which, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results

2. Development of hemodynamic instability following the stroke as manifested by a persistent post stroke systolic blood pressure less than 80 mm Hg (or are dependent on medications to maintain a systolic blood pressure greater than or equal to 80 mm Hg) or greater than 190 mm Hg at the time of screening

3. Presence of significant global or receptive aphasia that would interfere with the subject’s ability to understand and comply with study procedures or complete stroke assessments

4. Presence of abnormal clinical laboratory values on routine clinical laboratory testing at screening including alanine transaminase or aspartate transaminase greater than or equal to 3 times the upper limit of normal, serum creatinine greater than or equal to 3.0 mg/dL, or hemoglobin less than or equal to 10 g/dL, or any other laboratory investigation deemed by the investigator to be indicative of a clinically significant illness that could prevent the subject from complying with study procedures or impact on the outcome of the stroke assessment scales

5. History of drug or alcohol abuse (Appendix 10) that may impair the ability of the subject to give full informed consent, to participate fully in study procedures, or may impact the validity of the study results

6. History of any surgery or presence of any medical condition that, in the judgment of the investigator, may affect the validity of the study results

7. Current participation in another clinical study involving administration of an investigational product or history of such participation within 30 days of screening

8. Unable to complete baseline S-STREAM and NIHSS assessments within 48 hours of stroke onset

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