Clinical trial NCT05993221: Deconstructing Post Stroke Hemiparesis
Official title: Deconstructing Post Stroke Hemiparesis for Precision Neurorehabilitation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Lead sponsor: Providence VA Medical Center
Sponsor class: FED
First posted: 2023-08-15
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Veterans who have sustained a unilateral ischemic stroke at least six months prior to recruitment with resulting upper extremity deficit(s).

Brief summary: 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.

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

Primary outcomes:
measure: Fugl-Meyer Arm Motor Assessment
timeFrame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
Secondary outcomes:
measure: Edinburgh Handedness Inventory
timeFrame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
measure: Action Research Arm Test (ARAT)
timeFrame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
measure: Modified Ashworth Scale
timeFrame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
measure: Nottingham Sensory Assessment (Erasmus MC)
timeFrame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
measure: National Institute of Health Stroke Scale
timeFrame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
measure: Patient Health Questionnaire 9 (PHQ-9)
timeFrame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
measure: History of TBI
timeFrame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
measure: Barthel Index
timeFrame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
measure: Modified Rankin Scale
timeFrame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
measure: Defense and Veterans Pain Rating Scale
timeFrame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
measure: Manual Muscle Testing
timeFrame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent
Other outcomes:
Locations:
city: Providence
country: United States
facility: Providence VA Medical Center
state: Rhode Island
Study officials:
References: