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Screening Protocol for Patients With Stroke

This study is currently recruiting participants.
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Verified June 1, 2017 by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier:
NCT01021033
First received: November 25, 2009
Last updated: June 13, 2017
Last verified: June 1, 2017
November 25, 2009
June 13, 2017
November 2, 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. [ Time Frame: Ongoing ]
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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
Observational Model: Case-Only
Time Perspective: Other
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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 medical record report,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 or multiple strokes which affected the hand

EXCLUSION CRITERIA:

Subjects with the following will be excluded:

  • Large, cerebellar, or brainstem lesions
  • Recent or ongoing alcohol or drug abuse
  • Severe or progressive neurological disorder other than stroke as determined by the screening clinician.
  • Uncontrolled heart, lung, kidney, gastrointestinal, metabolic, or endocrine disorders as determined by the screening clinician
  • MRI contraindications as per NMR Center MRI Safety Screening Questionnaire.
  • Cognitive deficits defined as a mini-mental state exam score of 20 or less
Sexes Eligible for Study: All
18 Years to 100 Years   (Adult, Senior)
No
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 Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
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)
June 1, 2017

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