Cerebrovascular AccidentNCT00063180
Evaluating the Remote Effects of Stroke With MRI and PET Scans
An observational study of Cerebrovascular Accident, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cerebrovascular Accident
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2003to 20 Apr 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with MRI findings consistent with brain tumors, trauma or AVMs will be excluded.
- 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).
- 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.
- Subjects with a pre-stroke history of schizophrenia or bipolar disorders will be excluded.
- 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.
- Subjects with cancer will be excluded.
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- Patients not capable of giving an informed consent will be excluded
- Ethnic origin and race will not be biased for inclusion.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Remote Effects of Stroke on Cerebral Metabolism. Evaluation With Positron Emission Tomography and Proton Magnetic Resonance Spectroscopy
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.
Read the detailed description
Objective: Following a stroke, not only is there dysfunction of the lesioned area, but there is also remote functional depression of non-lesioned areas. This functional depression, called diaschisis, likely contributes to the functional deficit of the patient.
The objective of this study is to obtain a better understanding of the pathophysiology of diaschisis with the integrated methods of neuroimaging (positron emission tomography (PET) and proton magnetic resonance spectroscopy (H-MRS)).
Study population: We will recruit patients with subcortical stroke in the subacute state and in the chronic state, and normal controls.
Design: The stroke lesion will be the basal ganglia, internal capsule, thalamus, or cerebellum. The frontal cortex, including the motor cortex, is chosen as a remote area. Neurochemical changes in the diaschitic area will be investigated by measuring the glucose metabolic rate with PET, and concentrations of neurochemically important metabolites, such as gamma-aminobutyric acid (GABA) and glutamate, with H-MRS.
Outcome measures: Metabolic change in the diaschitic areas relative to the contra-lateral unaffected side will be calculated as a laterality index. First, this index will be compared among patient groups and control group. As a second analysis, the relationship of glucose metabolism measured by PET and concentrations of the metabolites detected by H-MRS will be evaluated.
- Conditions
- Cerebrovascular Accident
- Keywords
- Diaschisis, Glucose, GABA, N-Acetylaspartate, Glutamate, Stroke, Healthy Volunteer, HV
- Medical subject headings
- Stroke, Diaschisis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2003 (estimated)
- Study start19 Jun 2003
- Study completion20 Apr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 70 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00063180
- Sponsor's protocol ID
- 030224
- Other IDs
- 03-N-0224
- Status last verified
- 20 Apr 2009
- First submitted
- 20 Jun 2003
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Chang L, Cloak CC, Ernst T. Magnetic resonance spectroscopy studies of GABA in neuropsychiatric disorders. J Clin Psychiatry. 2003;64 Suppl 3:7-14.
PubMed 12662128Chu 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.
PubMed 11988598Brooks 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.
PubMed 11415962
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Effects of Stroke on Cerebral Metabolism. Evaluation With Positron Emission Tomography and Proton Magnetic Resonance Spectroscopy
- ClinicalTrials.gov ID
- NCT00063180
- Acronym / sponsor ID
- 030224
- Conditions
- Cerebrovascular Accident
- Keywords
- Diaschisis, Glucose, GABA, N-Acetylaspartate, Glutamate, Stroke, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 19 Jun 2003
- Study completion
- 20 Apr 2009
- First posted
- 23 Jun 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objective: Following a stroke, not only is there dysfunction of the lesioned area, but there is also remote functional depression of non-lesioned areas. This functional depression, called diaschisis, likely contributes to the functional deficit of the patient.
The objective of this study is to obtain a better understanding of the pathophysiology of diaschisis with the integrated methods of neuroimaging (positron emission tomography (PET) and proton magnetic resonance spectroscopy (H-MRS)).
Study population: We will recruit patients with subcortical stroke in the subacute state and in the chronic state, and normal controls.
Design: The stroke lesion will be the basal ganglia, internal capsule, thalamus, or cerebellum. The frontal cortex, including the motor cortex, is chosen as a remote area. Neurochemical changes in the diaschitic area will be investigated by measuring the glucose metabolic rate with PET, and concentrations of neurochemically important metabolites, such as gamma-aminobutyric acid (GABA) and glutamate, with H-MRS.
Outcome measures: Metabolic change in the diaschitic areas relative to the contra-lateral unaffected side will be calculated as a laterality index. First, this index will be compared among patient groups and control group. As a second analysis, the relationship of glucose metabolism measured by PET and concentrations of the metabolites detected by H-MRS will be evaluated.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- Patients with MRI findings consistent with brain tumors, trauma or AVMs will be excluded.
- 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).
- 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.
- Subjects with a pre-stroke history of schizophrenia or bipolar disorders will be excluded.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 12662128Chang L, Cloak CC, Ernst T. Magnetic resonance spectroscopy studies of GABA in neuropsychiatric disorders. J Clin Psychiatry. 2003;64 Suppl 3:7-14.
- Background: PubMed 11988598Chu 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.
- Background: PubMed 11415962Brooks 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Accident, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00063180, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.