Recruiting

Observational Study

Sponsor:

Providence VA Medical Center

Code:

NCT05993221

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Stroke

Study ID

NCT05993221

Start date

Sep 5, 2023

Status verified date

Jun, 2025

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

75 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Fugl-Meyer Arm Motor Assessment [ Time Frame: Assessment occurs at one cross-sectional timepoint within 2 weeks of research consent ]

Central Contacts and Locations

Central contacts

Jennifer Hebert, BS

401-273-7100jennifer.hebert@va.gov

Kelly Rishe, OT

401-273-7100kelly.rishe@va.gov

Locations

Providence VA Medical Center

Recruiting

Providence, Rhode Island, United States, 02908

Contacts

Chona Mcgrenery

401-273-7100chona.mcgrenery@va.gov

More Information

Sponsor

Providence VA Medical Center

Last update posted

Jun 6, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Providence VA Medical Center on 2025-06-06.