NIH Clinical Research Studies

Protocol Number: 03-N-0224

Active Accrual, Protocols Recruiting New Patients

Title:
Remote Effects of Stroke on Cerebral Metabolism. Evaluation with Positron Emission Tomography and Proton Magnetic Resonance Spectroscopy
Number:
03-N-0224
Summary:
Patients with stroke sometimes have a condition called diaschisis, a loss of function in a part of the brain located some distance from the original stroke-injury site. Doctors do not know why this happens.

The purpose of this study is to get a better understanding as to why diaschisis occurs by studying people who have experienced a stroke and people who have aged in good health.

Forty-four participants who are older than 40 year of age will be enrolled in this study-18 healthy people and 26 stroke patients. They will have 3 to 4 study visits. The first visit will involve a medical history and a physical and neurological exam. Participants will then have a magnetic resonance imaging (MRI) scan, either on the first visit or on a later day. On the next visit, they will undergo a position emission tomography (PET) scan. Finally, they will return for another MRI scan.

Sponsoring Institute:
National Institute of Neurological Disorders and Stroke (NINDS)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): None

Eligibility Criteria:
Patients with ischemic stroke in subacute state (2 to 12 weeks after onset)and the chronic state (more than one year after onset), with a single lesion confined to basal ganglia, internal capsule, thalamus, or a combination of two or three of these structures, or cerebellum, are eligible for this study, except for prior asymptomatic lacunar infarctions. Both ischemic infarction and hemorrhage will be included. The age of patients and controls will be over 40 years.

INCLUSION CRITERIA:

Patients will have a clinically and radiologically documented stroke in the subacute or the chronic state, with a single lesion confined to the basal ganglia, thalamus, internal capsule, or a combination of two or three of these structures, or cerebellum unilaterally. Both ischemic infarction and hemorrhage will be included; however, in cases of hemorrhage, we will exclude cases with deformation in the cerebral hemisphere due to mass effect of the hemorrhage, hydrocephalus, or extension to the ventricles. Patients will be over 40 years of age.

Healthy controls entering the study must be free of serious somatic disease as determined by a standard physical and neurological examination. Controls will be aged over 40 years.

Female patients and controls of child bearing potential will have a pregnancy test and specific interview prior to the study to ensure that pregnant patients will not participate in the study. Both patients and controls will be asked to abstain from alcohol for one week before the study.

EXCLUSION CRITERIA:

A. Patients with MRI findings consistent with brain tumors, trauma or AVMs will be excluded.

B. Patients with multiple stroke lesions will be excluded, except for prior asymptomatic lacunar infarctions.

C. Patients with severe stenosis (greater than 50%) or occlusion in internal cervical arteries and cerebral arteries detected by angiography or MRA will be excluded.

D. Subjects with a history of medical disorders which can affect the concentration of cerebral metabolites, including renal dysfunction, electrolyte abnormality and liver dysfunction, or requiring chronic treatment with drugs which may affect brain metabolism, including steroids, neuroleptic drugs, sleeping drugs and tranquilizers, will be excluded.

E. Subject with poorly controlled diabetes mellitus (Casual plasma glucose concentration greater than or equal to200 mg per dL (11.1 mmol per L) or fast plasma glucose concentration greater than or equal to126 mg per dL (7.0 mmol per L)) will be excluded.

F. Subjects with a history of psychiatric and mood disorders will be excluded.

G. Subjects with implanted devices such as pacemakers, medication pumps or defibrillators, metal in the cranium except mouth, intracardiac lines, history of shrapnel injury or any other condition/device that may be contraindicated or prevent the acquisition of MRI.

H. Subjects with cancer will be excluded.

I. Patients not capable of giving an informed consent will be excluded

J. Ethnic origin and race will not be biased for inclusion. However, for both patient s and controls, the number of males and females will be equal.

Participation of children:

Children will be excluded from the study because we need to study a homogeneous group of subjects by age and development changes in metabolites will complicate this study. Additionally, young children will not be sufficiently cooperative for the long periods of testing. Moreover, the radiation dose of the PET studies would subject them to relatively greater risk than the adults.

Special Instructions: Currently Not Provided
Keywords:
Diaschisis
Glucose
GABA
N-Acetylaspartate
Glutamate
Recruitment Keywords:
Stroke
Healthy Volunteer
HV
Conditions:
Cerebrovascular Accident
Investigational Drug(s):
[F-18]FDG
Investigational Device(s):
None

Contacts:
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:
Chang L, Cloak CC, Ernst T. Magnetic resonance spectroscopy studies of GABA in neuropsychiatric disorders. J Clin Psychiatry. 2003;64 Suppl 3:7-14. Review. PMID: 12662128

Chu WJ, Mason GF, Pan JW, Hetherington HP, Liu HG, San Pedro EC, Mountz JM. Regional cerebral blood flow and magnetic resonance spectroscopic imaging findings in diaschisis from stroke. Stroke. 2002 May;33(5):1243-8. PMID: 11988598

Brooks JC, Roberts N, Kemp GJ, Gosney MA, Lye M, Whitehouse GH. A proton magnetic resonance spectroscopy study of age-related changes in frontal lobe metabolite concentrations. Cereb Cortex. 2001 Jul;11(7):598-605. PMID: 11415962

Active Accrual, Protocols Recruiting New Patients

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