Summary

Eligibility
for people ages 18-85 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

Summary

This study will monitor patients during the first year following their stroke.

Stroke is a very serious condition where there is a sudden interruption of blood flow in the brain.

The main aim of the study will be to find out how many of those who experience their first-ever stroke then go on to develop spasticity that would benefit from treatment with medication.

Spasticity is a common post-stroke condition that causes stiff or ridged muscles.

The results of this study will provide a standard guideline on the best way to monitor the development of post-stroke spasticity.

Official Title

A Prospective, Multicountry Study to Estimate the Incidence of and Provide a Best Practice Model for Monitoring the Development of Post-Stroke Spasticity

Keywords

Spasticity as Sequela of Stroke, Muscle Spasticity, Stroke

Eligibility

You can join if…

Open to people ages 18-85

  • Participant must be aged 18 to 85 years at the time of providing informed consent
  • First-ever clinical stroke, defined according to World Health Organization criteria as rapidly developing clinical signs of focal (at times global) disturbance of cerebral function lasting more than 24 hours, within the past 4 weeks;
  • Confirmed paresis of the arms and/or legs which does not resolve within 1 day, according to the NIHSS score (a score of > 0 on Question 5 or 6 of the scale) within 2 weeks after the stroke
  • Capable of giving informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol

You CAN'T join if...

  • Upper or lower extremity functional impairment prior to stroke per investigator judgement (e.g., modified Rankin Scale >2);
  • Presence of significant/major neurological impairment that might affect muscle tone (other than limb paresis);
  • Severe multi-impairment or diminished physical condition before stroke that could have caused paresis/spasticity/motor deficit per investigator judgement;
  • Life expectancy of less than 12 months as a result of severity of stroke or other illnesses (e.g. cardiac disease, malignancy, etc.)
  • Participation in any interventional study

Locations

  • University Of California, Los Angeles Medical Center not yet accepting patients
    Los Angeles California 90095 United States
  • University Of Utah in progress, not accepting new patients
    Salt Lake City Utah 84112 United States
  • Methodist Physicians Clinic accepting new patients
    Omaha Nebraska 68114 United States
  • Medical College of Wisconsin accepting new patients
    Milwaukee Wisconsin 53226 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Ipsen
ID
NCT06055725
Study Type
Observational
Participants
Expecting 1051 study participants
Last Updated