Screening Protocol for Patients With Stroke

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01021033
First received: November 25, 2009
Last updated: August 22, 2014
Last verified: July 2014
  Purpose

Background:

  • Stroke, also known as acute cerebrovascular attack, is the leading cause of long-term disability worldwide. Stroke survivors are often left with permanent physical and mental disabilities.
  • Many stroke patients receive different therapies in an attempt to improve their independence and quality of life. However, current strategies are focused on the acute stage after stroke and are of limited influence in improving stroke outcome. One of the main problems of patients who have suffered a stroke is the difficulty in using the hand on the opposite side of the affected hemisphere of the brain; to date, researchers have no successful means to improve the hand function in chronic stages of stroke.
  • Researchers are interested in developing a pool of individuals for further research into hand and motor function after a stroke.

Objectives:

- To perform a screening evaluation of patients referred with stroke to determine their eligibility for current and future protocols studying the effects of stroke on the nervous system and motor function.

Eligibility:

- Individuals who have experienced a single stroke on only one side of the brain that occurred at least 3 months prior to participation in the screening study. Individuals must have some residual hand motor function.

Design:

  • Participants in this study will be recruited from patient referrals.
  • Eligible participants will undergo a 4- to 5-hour screening with a medical history, physical and neurological examination, stroke evaluation, and an anatomical magnetic resonance imaging (MRI) of the brain. The screening visit may be done over the course of more than one day, if needed for patient convenience or test availability.
  • In addition to the initial outpatient visit, subjects may remain enrolled in this study for up to 15 years and may be contacted to see if they qualify for new branch studies. Subjects may be re-examined up to once per year while they remain in this protocol to confirm ongoing eligibility. The re-examination visits will involve a neurologic evaluation and possible repeat MRI.
  • No clinical care will be provided under this protocol..

Condition
Stroke

Study Type: Observational
Official Title: Screening Protocol for Patients With Stroke

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • This is a screening protocol. The primary outcome measure is the number of subjects who subsequently enroll in HCPS studies.

Estimated Enrollment: 1200
Study Start Date: November 2009
Detailed Description:

Objective:

The purpose of this protocol is to perform a screening evaluation of patients referred with stroke to determine their eligibility for current and future protocols aimed at understanding the mechanisms underlying plastic changes in the human central nervous system, and how the non-invasive stimulation of the motor cortex could improve motor function in patients with chronic stroke.

Study population:

Twelve hundred adult patients with monohemispheric single stroke, that occurred at least 3 months prior to participation in this screening study, and with some residual hand motor function will be enrolled.

Design:

This is a screening protocol to determine eligibility for other branch protocols.

Outcome measures:

The outcome measure is the number of subjects who subsequently enroll in HCPS studies.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

This study will enroll:

  • Patients with stroke documented by CT or Magnetic resonance imaging (MRI) at least 3 months prior to enrollment
  • Patients between the ages of 18 and 90
  • Patients who are willing and able to give their own consent
  • Patients with monohemispheric, single stroke which affected the hand

EXCLUSION CRITERIA:

Subjects with the following will be excluded:

  • Large cortical, cerebellar, or brainstem lesions
  • Profound hand impairment unable to extend metacarpophalangeal (MP) joints at least 10-20 degrees at the time of screening< TAB>
  • Recent or ongoing alcohol or drug abuse
  • Any severe or progressive neurological disorder such as uncontrolled Parkinson s disease, Alzheimer s disease, multiple sclerosis, and other central or peripheral nervous system diseases aside from stroke.
  • Uncontrolled heart, lung, kidney, gastrointestinal, metabolic, or endocrine disorders as determined by the screening physician
  • MRI contraindications, pregnancy, cardiac pacemakers, intracardiac lines, implanted medication pumps, neural stimulators, eye, blood vessel, cochlear, or eye implants, metal in the cranium except in the mouth, dental braces, metal fragments from occupational exposure, surgical clips in or near the brain, and claustrophobia
  • Cognitive deficits defined as a mini-mental state exam score of 20 or less
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01021033

Contacts
Contact: Rita Volochayev, C.R.N.P. (301) 402-0546 volochar@mail.nih.gov
Contact: Leonardo G Cohen, M.D. (301) 496-9782 cohenl1@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Leonardo G Cohen, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT01021033     History of Changes
Other Study ID Numbers: 100012, 10-N-0012
Study First Received: November 25, 2009
Last Updated: August 22, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Ischemia
Hemorrhage
Rehabilitation
Stroke

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 30, 2014