Screening Protocol for Patients With Stroke

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 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: May 21, 2014
Last verified: September 2013

November 25, 2009
May 21, 2014
November 2009
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This is a screening protocol. The primary outcome measure is the number of subjects who subsequently enroll in HCPS studies.
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Complete list of historical versions of study NCT01021033 on ClinicalTrials.gov Archive Site
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Screening Protocol for Patients With Stroke
Screening Protocol for Patients With Stroke

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..

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.

Observational
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Stroke
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1200
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  • 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
Both
18 Years and older
No
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
United States
 
NCT01021033
100012, 10-N-0012
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National Institute of Neurological Disorders and Stroke (NINDS)
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Principal Investigator: Leonardo G Cohen, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health Clinical Center (CC)
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP