Evaluating the Remote Effects of Stroke With MRI and PET Scans

NCT00063180 | Completed

• 2 other identifiers: 03022403-N-0224
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebrovascular Accident

Keywords

Diaschisis; Glucose; GABA; N-Acetylaspartate; Glutamate; Stroke; Healthy Volunteer; HV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will have a clinically and radiologically documented stroke in the subacute (2 weeks to 6 months to after onset) or the chronic state (more than 6 months after onset), having a lesion in subcortical regions including the basal ganglia, thalamus, internal capsule, or a combination of these structures, or cerebellum unilaterally. These lesions can extend to the surrounding areas, however not including the cerebral areas where H-MRS ROI will be located. 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 18 years of age or older.
• 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 18 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 each of the PET and H-MRS scans.

You may not qualify if:

• 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 or stroke lesions which are not known to cause diaschisis in the frontal cortex (occipital cortex).
• C. Patients with severe stenosis (greater than 70%) or occlusion in internal cervical arteries and in the proximal portions of middle or frontal cerebral arteries detected by angiography or MRA will be excluded. Subjects with medical disorders which can affect the concentration of cerebral metabolites, including renal failure, hepatic failure and untreated electrolyte abnormality will be excluded. Subjects with poorly controlled diabetes mellitus (casual plasma glucose concentration greater than or equal to 200 mg per dL (11.1 mmol per L) or fast plasma glucose concentration greater than or equal to 126 mg per dL (7.0 mmol per L) will be excluded. Subjects who are taking sleeping drugs or tranquilizers will be asked to stop taking them for two days prior to each of the PET and H-MRS scans.
• D. Subjects with a pre-stroke history of schizophrenia or bipolar disorders will be excluded.
• E. 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.
• F. Subjects with cancer will be excluded.
• G. Patients not capable of giving an informed consent will be excluded
• Participation of children:
• Children will be excluded from the study because we need to study a homogeneous group of subjects by age and developmental 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.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

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

  PMID: 12662128 BACKGROUND

• 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. doi: 10.1161/01.str.0000015240.75199.be.

  PMID: 11988598 BACKGROUND

• 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. doi: 10.1093/cercor/11.7.598.

  PMID: 11415962 BACKGROUND

MeSH Terms

Conditions

Stroke; Diaschisis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 20, 2003
• First Posted: June 23, 2003
• Study Start: June 19, 2003
• Study Completion: April 20, 2009
• Last Updated: July 2, 2017

Record last verified: 2009-04-20

Locations

US (1)