Stroke Motor Rehabilitation and Recovery Study

NCT ID: NCT03485040

Last Updated: 2025-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-09

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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Participants will be enrolled in the SMaHRT study during their acute stroke hospitalization and will have research visits spanning the post-stroke care continuum at approximately 6 weeks, 3 months, 6 months, one year, two years, and three years after stroke. The study will collect demographics and clinical outcome measures, clinical neuroimages, video and robot-kinematic data and neurophysiology data through TMS and EEG in order to quantify the course of motor recovery. The research visits may be accompanied by a comprehensive clinical visit to the Massachusetts General Hospital Neurorecovery Clinic. The goal is to understand the behavioral, neuroanatomic, and neurophysiologic underpinnings of motor recovery toward developing personalized strategies and neurotechnologies to facilitate neurorehabilitation and enable better recovery for people with stroke.

Conditions

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Stroke, Ischemic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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David Lin

Neurologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David J Lin, MD

Role: PRINCIPAL_INVESTIGATOR

Neurologist

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Julie A DiCarlo, MS

Role: CONTACT

617-726-1311

Maryam Masood, MSC

Role: CONTACT

References

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Kline DK, Lin DJ, Cloutier A, Sloane K, Parlman K, Ranford J, Picard-Fraser M, Fox AB, Hochberg LR, Kimberley TJ. Arm Motor Recovery After Ischemic Stroke: A Focus on Clinically Distinct Trajectory Groups. J Neurol Phys Ther. 2021 Apr 1;45(2):70-78. doi: 10.1097/NPT.0000000000000350.

Reference Type BACKGROUND
PMID: 33707402 (View on PubMed)

Lin DJ, Erler KS, Snider SB, Bonkhoff AK, DiCarlo JA, Lam N, Ranford J, Parlman K, Cohen A, Freeburn J, Finklestein SP, Schwamm LH, Hochberg LR, Cramer SC. Cognitive Demands Influence Upper Extremity Motor Performance During Recovery From Acute Stroke. Neurology. 2021 May 25;96(21):e2576-e2586. doi: 10.1212/WNL.0000000000011992. Epub 2021 Apr 15.

Reference Type BACKGROUND
PMID: 33858997 (View on PubMed)

Kuo YL, Lin DJ, Vora I, DiCarlo JA, Edwards DJ, Kimberley TJ. Transcranial magnetic stimulation to assess motor neurophysiology after acute stroke in the United States: Feasibility, lessons learned, and values for future research. Brain Stimul. 2022 Jan-Feb;15(1):179-181. doi: 10.1016/j.brs.2021.12.001. Epub 2021 Dec 7. No abstract available.

Reference Type BACKGROUND
PMID: 34890840 (View on PubMed)

Other Identifiers

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2017P000868

Identifier Type: -

Identifier Source: org_study_id

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