Deconstructing Post Stroke Hemiparesis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Stroke. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Deconstructing Post Stroke Hemiparesis for Precision Neurorehabilitation
Overview
TRACTs (DeconsTructing Post StRoke HemipAresis for PreCision NeurorehabiliTation) is a single timepoint study that aims to deconstruct post-stroke deficits of the upper extremity into distinct components and relate these components to brain anatomy and physiology.
Detailed description
Veterans will be recruited through the Providence Veterans Affairs Medical Center and will have research visits at the Providence VA Center for Neurorestoration and Neurotechnology (CfNN, centerforneuro.org). The research visits will span two to three days. The study will involve motor outcome measures, magnetic resonance imaging of the brain, and transcranial magnetic stimulation. The goal of this study is to associate post-stroke deficits of the upper extremity with brain anatomy and physiology.
Primary outcome measures
- Fugl-Meyer Arm Motor Assessment [Time frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent]
Secondary outcome measures (12)
- Edinburgh Handedness Inventory [Time frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent]
- Action Research Arm Test (ARAT) [Time frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent]
- Modified Ashworth Scale [Time frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent]
- Nottingham Sensory Assessment (Erasmus MC) [Time frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent]
- National Institute of Health Stroke Scale [Time frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent]
- Montreal Cognitive Assessment (MoCA) [Time frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent]
- Patient Health Questionnaire 9 (PHQ-9) [Time frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent]
- History of TBI [Time frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent]
- Barthel Index [Time frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent]
- Modified Rankin Scale [Time frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent]
- Defense and Veterans Pain Rating Scale [Time frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent]
- Manual Muscle Testing [Time frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent]
Eligibility criteria
Inclusion criteria
- Diagnosis of a unilateral ischemic stroke occurring >6 months prior as documented in medical chart
- Upper extremity motor impairment as measured by Fugl-Meyer Upper Extremity Assessment ≤60
- Ability to follow simple instructions in English
Exclusion criteria
- Greater than moderate difficulty using the arm and hand pre-dating the stroke as assessed by the questions adapted from the QuickDASH outcome measure score on any question >= 3, which measures physical function and symptoms in people with difficulty using the arm and hand.
- Visual or auditory disorders resulting in the inability to see or hear, respectively, the stimuli presented as part of research sessions
- Inability to maintain a seated position for at least one hour
- Standard MRI exclusion (e.g., significant claustrophobia or inability to tolerate loud noises, cardiac pacemaker (unless MRI-safe), implanted device (deep brain stimulation) or metal in the brain, cervical spinal cord, or upper thoracic spinal cord)
- Standard (single-pulse) TMS exclusion which include (in addition to those listed for MRI) pregnancy/lactation/planning to become pregnant during the study, seizure disorder, and primary or secondary CNS tumors
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Providence VA Medical Center — Providence
Identifiers
NCT: NCT05993221 · 1689966