Clinical trial NCT04850001: Cognitive Decline in Asymptomatic Intracranial Stenosis Patients: A 1-Year Follow-Up Study
Official title: Investigating the Changes of the Cognition in Asymptomatic Intracranial Stenosis Patients After 1-Year Standard Medical Treatment Without Stenting
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Magnetic Resonance Imaging
Asymptomatic Intracranial Stenosis
Medical Treatment
Keywords: Magnetic Resonance Imaging
Asymptomatic Intracranial Stenosis patients
Cognitive function
Medical Treatment
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2021-04-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with intracranial stenosis which was defined as stenosis of 50% or more in Intracranial segment of internal carotid artery and middle cerebral artery (MCA) without history of stroke,transient ischemic attack,seizures or unexplained loss of consciousness.The degree of stenosis was measured by transcranial doppler, computed magnetic resonance angiography (MRA),tomography angiography (CTA) and digital subtraction angiography (DSA).

Brief summary: To investigate the cognitive decline after standard medical treatment without stenting in Asymptomatic Intracranial Stenosis patients and the underlying neural mechanism by fMRI.

Detailed description: All participants underwent a medical evaluation that included routine laboratory studies before and after 1-year standard medical treatment. Upon meeting the inclusion criteria and providing informed consent, each participant will complete a battery measure of neuropsychological tests and Magnetic Resonance imaging scan in multimodalities within 7 days after admission and after 1-year when patients received standard medical treatment at the First Affiliated Hospital of AnHui Medical University. participants were randomly allocated to patient group and the control group.There are about 20 patients and 20 healthy controls in this study.

Firstly, a series of neuropsychological tests were obtained by a trained investigator to assess baseline. Each assessment will involve a set of assessment tools, the memory as the primary outcome measure and various other tasks and questionnaires to measure cognition (including MoCA,MMSE, DS, Stroop test, TMT, VFT), memory (CAVLT), emotion (HAMA-17,HAMD-14), behavioral and psychological symptoms(NPI). All the tests are conducted in two days. The patients had receiving a magnetic resonance imaging scan in multi-modalities.

After 1-year standard medical treatment,the patients participants were interviewed to obtain the same assessment and magnetic resonance imaging scan in multi-modalities as before. Patients are instructed to focus their answers on the past 15 days. The clinical symptom of participants were followed 6 and 12 months after the admission. Afterwards, they were unblinded by the study coordinator.

Eligibility criteria: Inclusion Criteria:

* Patients with intracranial stenosis which was defined as stenosis of 50% or more in Intracranial segment of internal carotid artery and middle cerebral artery (MCA).
* The degree of stenosis was measured by transcranial doppler, computed magnetic resonance angiography (MRA),tomography angiography (CTA) and digital subtraction angiography (DSA).

Exclusion Criteria:

* History of stroke,transient ischemic attack,seizures or unexplained loss of consciousness.
* Organic brain defects on T1 or T2 images.
* Any history or clinical signs of other severe psychiatric illnesses (like major depression,psychosis or obsessive compulsive disorder).
* Implanted pacemaker,medication pump,vagal stimulator,deep brain stimulator. History of substance abuse within the last 6 months.

Primary outcomes:
measure: Changes in Memory
timeFrame: baseline, 1-year after medical treatment
Secondary outcomes:
measure: The changes in MMSE(Mini Mental State Examination)
timeFrame: baseline, 1-year after medical treatment
measure: DST (Digital Span Test; Forward and Backward)
timeFrame: baseline, 1-year after medical treatment
measure: TMT (Trail Making Test)
timeFrame: baseline, 1-year after medical treatment
measure: HAMD (Hamilton Depression Scale)
timeFrame: baseline, 1-year after medical treatment
measure: HAMA (Hamilton Anxiety Scale)
timeFrame: baseline, 1-year after medical treatment
measure: MRI measures
timeFrame: baseline, 1-year after medical treatment
measure: changes in Montreal Cognitive Assessment (MoCA)
timeFrame: baseline, 1-year after medical treatment
measure: The Stroop color test
timeFrame: baseline, 1-year after medical treatment
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Medical University
state: Anhui
Study officials:
References: