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Clinical Trials/NCT01781689
NCT01781689CompletedNot Applicable

The Relationship Between Motor Cortex Oxygenation and Motor Function Recovery in Stroke Patients

Kaohsiung Veterans General Hospital.2 sites in 1 country10 target enrollmentStarted: October 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
10
Locations
2
Primary Endpoint
Cortical activation

Study Overview

Brief Summary

Stroke is the most common cause of motor function impairment. However, the functional impairment is not totally irreversible. Several mechanisms may involved in both the cortical and motor function recovery after onset of stroke, and most of them are related to changes of cortical perfusion and metabolism.

Motor function recovery after stroke (especially middle cerebral artery territory lesion) frequently follow stereotypic pattern (brunnström stage).

This study is designed to investigate the relationship between motor cortex oxygenation/metabolism and motor function recovery after stroke. To seek if there is similar stereotypic pattern of motor cortex oxygenation/metabolism change during the recover stage after stroke.

Detailed Description

Participants receive evaluations (1/week for 3 months period) of

  • motor function (Include: MMSE, brunnström stage, Fugl-Meyer Assessment of Physical Performance, Box and Block Test of Manual Dexterity, Functional Independence Measure)
  • cortical perfusion detection during performing limb movements (using NIRS)

Then use path analysis to investigate the relationship between motor cortex oxygenation/metabolism and motor function recovery after stroke.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
45 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Ischemic stroke(unilateral, onset within 7 days, without previous stroke history)
  • Vital sign stable
  • Upper extremity motor function impairment(brunnström stage I~III)

Exclusion Criteria

  • with pacemakers
  • Seizure history
  • Serious dysrhythmias
  • Poor cognition function(MMSE<13)

Outcomes

Primary Outcomes

Cortical activation

Time Frame: weekly changes within 3 months

Using Near-infrared spectroscopy to measure cortical activation changes weekly for 3 months

Secondary Outcomes

  • motor function(weekly changes within 3 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Zheng-Yu Hoe, MD., PhD.

Principal Investigator

Kaohsiung Veterans General Hospital.

Study Sites (2)

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