Biomarkers of Independent Walking Post-Stroke

NCT05004389 | Unknown

• 2 other identifiers: 00000696P20GM135007
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Prediction of walking recovery after stroke can inform patient-centered care and support discharge planning. The accuracy of current prediction models is limited, however, due to small study designs and narrow predictors assessed. The investigators propose a comprehensive evaluation of a novel combination of biomarkers to improve prediction of walking recovery and guide rehabilitation efforts after stroke. These include acute structural brain network disruption (utilizing MRI); blood biomarker levels (e.g., brain-derived neurotrophic factor and vascular endothelial growth factor); and clinical assessments of strength and mobility. The overall study objectives are to assess protocol feasibility and investigate relationships between select biomarkers and walking recovery to provide strong justification for a larger study on predictors of independent walking after stroke. The proposed objectives will be pursued through the following specific aims: 1) Assess feasibility of a larger study and develop methods for telehealth data collection; 2) Establish baseline levels of biomarkers and average change over time; and 3) Elucidate relationships between baseline levels of biomarkers and walking gains across time in persons after stroke. A longitudinal, observational study design will be utilized for this study. Thirty-five persons with acute (≤7 days) stroke will be recruited from the local medical center. Select inclusion criteria include presence of new lower limb weakness and assistance for walking; select exclusion criteria include cerebellar stroke or other neurological disorders such as Parkinson's Disease. Subjects will undergo clinical evaluation at week 1, 4, 9, 12, and 26 weeks post-stroke. MRI scans will occur within 12 days post-stroke and at 12 weeks post-stroke, and blood draws within 1 week, 1 to 2 weeks and at 12 weeks post-stroke. To assess feasibility the investigators will examine study processes, recruitment, resources, study management, and scientific assessment. To examine the role of acute clinical, neuroimaging, and physiological measures in predicting walking recovery, the investigators will examine relationships between these measures and walking outcome at 12-weeks post-stroke. The proposed research is expected to provide strong scientific support for future clinical trials designed to target therapies based on predicted functional potential. Such knowledge has the potential of enhancing mobility gains and patient independence following stroke.

Conditions

Stroke, Acute; Gait, Hemiplegic

Outcome Measures

Primary Outcomes (4)

• Change in Functional Ambulation Category

  Assessment of walking assistance

  week 1, week 4, week 9, week 12, and week 26 s/p stroke

• Change in diffusion tensor imaging

  fractional anisotropy and structural connectivity metrics

  within 12 days and at 12 weeks post-stroke

• Change in blood markers - BDNF

  serum BDNF

  within week 1, at 1-2 weeks and at 12 weeks post-stroke

• Change in blood markers - VEGF

  serum VEGF

  within week 1, at 1-2 weeks and at 12 weeks post-stroke

Secondary Outcomes (21)

• Change in National Institutes of Health Stroke Scale

  within 72 hours and 1 week post-stroke

• Mini-Mental Status Exam

  1 week post-stroke

• Change in 3-meter walk test

  week 1, week 4, week 9, week 12, and week 26 s/p stroke

• Change in Trunk Control Test

  week 1, week 4, week 9, week 12, and week 26 s/p stroke

• Change in lower extremity muscle strength as assessed by Medical Research Council grades

  week 1, week 4, week 9, week 12, and week 26 s/p stroke

Study Arms (1)

Acute Stroke

Persons ≥ 18 years of age with acute (≤ 7 days) ischemic or intracerebral hemorrhagic stroke.

Diagnostic Test: MRI; Diagnostic Test: blood draw; Other: Clinical assessments

Interventions

MRI DIAGNOSTIC_TEST

white matter integrity and brain structural connectivity metrics

Acute Stroke

blood draw DIAGNOSTIC_TEST

post-stroke serum/plasma levels of BDNF, VEGF, IL-6, IL-10, CRP, TNFalpha, MMPs, IGF-1, cGP

Acute Stroke

Clinical assessments OTHER

measures of strength, balance, and mobility

Acute Stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults (age ≥ 18 years old) with acute ischemic or intracerebral hemorrhagic stroke from the local medical center.

Sponsors & Collaborators

• University of Vermont: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

University of Vermont Medical Center

Burlington, Vermont, 05405, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, plasma

MeSH Terms

Conditions

Stroke; Gait Disorders, Neurologic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Denise Peters, DPT, PhD

  University of Vermont

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Denise Peters, DPT, PhD

CONTACT

802-656-1709; denise.peters@med.uvm.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 13, 2021
• Study Start: December 2, 2021
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: March 14, 2023

Record last verified: 2023-03

Locations

US (1)