Recruiting

Rehabilitation

Sponsor:

Massachusetts General Hospital

Code:

NCT03485040

Conditions

Stroke, Ischemic

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

SMaHRT (Stroke Motor reHabiliation and Recovery sTudy) is a longitudinal study aimed at understanding the natural history of upper extremity motor recovery after ischemic and hemorrhagic stroke.

Conditions

Stroke, Ischemic

Study ID

NCT03485040

Start date

Jun 9, 2017

Status verified date

May, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria

  • Age 18 - 90
  • Upper extremity motor weakness after ischemic and/or hemorrhagic stroke as defined by a score of >=1 on NIH Stroke Scale Arm Motor Drift Questions 5A or 5B
  • Ability to follow simple commands in English
  • Score of zero or 1 on the NIH Stroke Scale Level of Consciousness Questions 1a and 1b and a score of zero on the NIH Stroke Scale Level of Consciousness Question 1c.
  • Stable medical status as determined by primary care team
  • Inpatient on the MGH stroke neurology service

Exclusion Criteria

  • Prior history of developmental, neurologic, or major psychiatric disorder resulting in functional disability
  • Prior history of visual or auditory disorders limiting ability to participate in testing
  • Evidence of an uncontrolled seizure disorder
  • Patients for whom EEG leads are contraindicated

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Fugl-Meyer Arm Motor Assessment [ Time Frame: Time 1: During acute hospitalization; Time 2: approx. 6 weeks after stroke date; Time 3: approx. 90 days after stroke date; Time 4: approx. 180 days after stroke date; Time 5: approx. 1 year after stroke date Time 6: N/A; Time 7: N/A ]

Central Contacts and Locations

Central contacts

Julie A DiCarlo, MS

617-726-1311jdicarlo2@mgh.harvard.edu

Maryam Masood, MSC

mmasood@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

More Information

Sponsor

Massachusetts General Hospital

Last update posted

May 15, 2025

Last verified

May, 2025

Keywords

  • Rehabilitation
  • Neurorehabilitation
  • Neurotechnology
  • Neurorecovery
  • Neurorestoration

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-05-15.