Subarachnoid HemorrhageNCT01919775
Amnesia After Surgery for Anterior Communicating Aneurysm： High Resolution Magnetic Resonance (MR) Imaging Findings
An observational study of Subarachnoid Hemorrhage and Cerebral Aneurysm, run by Tohoku University.
Trial summary
To clarify whether amnesia after treatment of anterior communicating aneurysm (ACoA)is related to infarcts caused by occlusion or damage of the perforating artery of the ACoA, we used 3.0-T 3D high resolution MR imaging to identify and localize infarcts in patients with amnesia following treatment of ACoA aneurysm. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Subarachnoid Hemorrhage, Cerebral Aneurysm, Amnesia
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Dec 2007to Jul 2013
- How long will I take part?
- 6 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with amnesia following surgical treatment of the ACoA aneurysm.
Who may be able to join
- Clinical diagnosis of Amnesia
Who cannot join
- Severe decreased intellectual function
About this study
Official title: Basal Forebrain Amnesia After Surgery for Anterior Communicating Aneurysm： High Resolution 3-dimensional (3D) Magnetic Resonance (MR) Imaging Findings
To clarify whether amnesia after treatment of anterior communicating aneurysm (ACoA)is related to infarcts caused by occlusion or damage of the perforating artery of the ACoA, we used 3.0-T 3D high resolution MR imaging to identify and localize infarcts in patients with amnesia following treatment of ACoA aneurysm.
Read the detailed description
Cohort register is made by experienced neuropsychologists in our institute.
MR imaging and data storage is in the department of diagnostic radiology of our institute.
MR images are evaluated by two neuroradiologists using a work station.
- Conditions
- Subarachnoid Hemorrhage, Cerebral Aneurysm, Amnesia
- Medical subject headings
- Subarachnoid Hemorrhage, Intracranial Aneurysm, Amnesia
What is being measured
The primary outcome is the main question the study is designed to answer.
cerebral infarction identified and localized in the basal forebrain on MR imaging
Measured: within 15 months from the aneurysmal treatment(an expected average 4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startDec 2007
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 14 participants (actual)
- Target duration
- 6 Years
Sponsor and investigators
- Lead sponsor
- Tohoku University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shunji MUGIKURA, Tohoku University
- Investigators
- Shoki Takahashi, Professor, Study director, Department of Diagnostic Radiology, Tohoku University, Graduate School of Medicine, Sendai, Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919775
- Sponsor's protocol ID
- tohoku-ACoA amnesia MRI
- Status last verified
- Aug 2013
- First submitted
- 7 Aug 2013
- Last updated
- 9 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Basal Forebrain Amnesia After Surgery for Anterior Communicating Aneurysm： High Resolution 3-dimensional (3D) Magnetic Resonance (MR) Imaging Findings
- ClinicalTrials.gov ID
- NCT01919775
- Acronym / sponsor ID
- tohoku-ACoA amnesia MRI
- Conditions
- Subarachnoid Hemorrhage, Cerebral Aneurysm, Amnesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Tohoku UniversityUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 9 Aug 2013 (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.
To clarify whether amnesia after treatment of anterior communicating aneurysm (ACoA)is related to infarcts caused by occlusion or damage of the perforating artery of the ACoA, we used 3.0-T 3D high resolution MR imaging to identify and localize infarcts in patients with amnesia following treatment of ACoA aneurysm.
Detailed description
Cohort register is made by experienced neuropsychologists in our institute.
MR imaging and data storage is in the department of diagnostic radiology of our institute.
MR images are evaluated by two neuroradiologists using a work station.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with amnesia following surgical treatment of the ACoA aneurysm.
Key inclusion criteria (1 listed)
- Clinical diagnosis of Amnesia
Key exclusion criteria (1 listed)
- Severe decreased intellectual function
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
cerebral infarction identified and localized in the basal forebrain on MR imaging
Time frame: within 15 months from the aneurysmal treatment(an expected average 4 months)
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 9 Aug 2013.
Related trials for Subarachnoid Hemorrhage
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
RecruitingObservational study
Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Spontaneous, Subarachnoid Hemorrhage, Aneurysmal
RecruitingObservational study
Smartphone Enabled Detection of Cognitive Motor Dissociation in the ICU
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke
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.
Shoki Takahashi, Professor study director
Department of Diagnostic Radiology, Tohoku University, Graduate School of Medicine, Sendai, Japan
Questions about this trial
What is this clinical trial studying?
An observational study of Subarachnoid Hemorrhage and Cerebral Aneurysm, run by Tohoku University.
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 1 inclusion and 1 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 9 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
cerebral infarction identified and localized in the basal forebrain on MR imaging (time frame: within 15 months from the aneurysmal treatment(an expected average 4 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2013.