Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04456348
Other study ID # 2018YFC1312900-01
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 1, 2020
Est. completion date December 31, 2021

Study information

Verified date November 2019
Source Shanghai Zhongshan Hospital
Contact Beini Fei, MB
Phone +86 13701699684
Email fbeini@sina.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is a multi-center prospective cohort study. We will continuously recruit subjects with silent cerebrovascular disease aged 60 to 85 years from Shanghai and Guizhou. Data including demographic characteristics, medical history, other concomitant diseases, neurological function assessments, laboratory examinations, imaging examinations, and other clinical data and health economics survey responses will be collected from all subjects.

At baseline, all subjects will undergo gait assessment using the intelligent system and cognitive function scale assessment by clinicians. According to the intelligent gait results, the subjects will be divided into normal and abnormal gait groups. All subjects will be observed naturally for 1 year, and all medical behaviors will be recorded. All subjects will be interviewed by telephone for the occurrence of vascular events and changes in medical behaviors at half a year after enrollment and followed up at 1 year after enrollment, including gait evaluation using the intelligent system and cognitive function scale evaluation by clinicians. During the follow-up period, patients can visit the hospital for follow-up at any time when their condition changes.


Description:

The neurological function of all subjects was assessed based on the following tests under the guidance of a physician. The timed up-and-go test was used to evaluate the subjects' gait function, requiring them to stand up from their seat and walk straight forward for 3 meters, turn around, walk straight back to the chair, and then sit down again. Using simple cognitive evaluation (Mini-Cognitive Assessment) screening of the subjects' memory and executive function, the participants will first be asked to remember three unrelated words and immediately repeat the three words; they will then be asked to draw a clock marked with the numbers and pointers, and eventually recall the three words. The verbal function of the subjects will be assessed using the verbal retelling items in the MMSE and Montreal Cognitive Assessment, asking the subjects to clearly repeat "44 stone lions," "I only know Zhang Liang came to help today," and "the cat always hid under the sofa when the dog was in the room." Through the camera image data record, the intelligent system uses the built-in intelligent algorithm for intelligent video gait recognition and neural networks based on depth interpretation automation and automatic access to the subjects' gait characteristics (stand-up time, turnaround time, stride length, step velocity, stride length, step width, etc.), language features (pronunciation, intonation, word order, language accuracy, language fluency, etc.), and clock features.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1600
Est. completion date December 31, 2021
Est. primary completion date October 31, 2021
Accepts healthy volunteers No
Gender All
Age group 60 Years to 85 Years
Eligibility Inclusion Criteria:

1. Aged between 60 and 85 years.

2. Diagnosed with silent cerebrovascular disease/silent stroke, which is consistent with the 2016 statement issued by the American Heart Association (AHA) and American Stroke Association (ASA):

1. No previous clear history of stroke and no clinical symptoms or mild clinical symptoms that fail to attract clinical attention;

2. Cranial MRI showing at least one of the following within 5 years: lacunar infarct of vascular origin; white matter hyperintensity of vascular origin; cerebral microbleeds;

3. Consciousness and ability to complete cognitive assessment

4. Ability to stand and walk independently and complete gait assessment without assistance from others.

5. Ability to sign the informed consent.

Exclusion Criteria:

1. Intracranial lesions that have been clearly diagnosed as demyelination disease, white matter dystrophy, intracranial space-occupying lesions, or autoimmune encephalitis.

2. Gait disorder that has been diagnosed as Parkinson's disease, normal cranial hydrocephalus, an otogenic disease, subacute combined degeneration, peripheral neuropathy, osteoarthritis, or lumbar disease.

3. Cognitive disorders that have been diagnosed, such as Alzheimer's disease, frontotemporal dementia, Lewy body dementia, etc.

4. Severe neurological diseases such as previous cerebral trauma, epilepsy, and myelopathy, etc.

5. Severe cardiovascular complications and intolerance to the assessment

6. Severe visual or hearing impairment, aphasia, cognitive disorder, gait disorder, etc., that results in the inability to cooperate for cognitive and gait assessment

7. Refusal to participate in the study

8. Other anomalies that could not be included in the exclusion criteria, but are considered inappropriate to be included in this study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
there is no intervention
There is no intervention

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Shanghai Zhongshan Hospital Fudan University, The Affiliated Hospital Of Guizhou Medical University

References & Publications (19)

Brickman AM, Provenzano FA, Muraskin J, Manly JJ, Blum S, Apa Z, Stern Y, Brown TR, Luchsinger JA, Mayeux R. Regional white matter hyperintensity volume, not hippocampal atrophy, predicts incident Alzheimer disease in the community. Arch Neurol. 2012 Dec;69(12):1621-7. doi: 10.1001/archneurol.2012.1527. — View Citation

de Laat KF, van Norden AG, Gons RA, van Oudheusden LJ, van Uden IW, Bloem BR, Zwiers MP, de Leeuw FE. Gait in elderly with cerebral small vessel disease. Stroke. 2010 Aug;41(8):1652-8. doi: 10.1161/STROKEAHA.110.583229. Epub 2010 Jun 24. — View Citation

Debette S, Markus HS. The clinical importance of white matter hyperintensities on brain magnetic resonance imaging: systematic review and meta-analysis. BMJ. 2010 Jul 26;341:c3666. doi: 10.1136/bmj.c3666. Review. — View Citation

Dumurgier J, Artaud F, Touraine C, Rouaud O, Tavernier B, Dufouil C, Singh-Manoux A, Tzourio C, Elbaz A. Gait Speed and Decline in Gait Speed as Predictors of Incident Dementia. J Gerontol A Biol Sci Med Sci. 2017 May 1;72(5):655-661. doi: 10.1093/gerona/ — View Citation

Feigin VL, Forouzanfar MH, Krishnamurthi R, Mensah GA, Connor M, Bennett DA, Moran AE, Sacco RL, Anderson L, Truelsen T, O'Donnell M, Venketasubramanian N, Barker-Collo S, Lawes CM, Wang W, Shinohara Y, Witt E, Ezzati M, Naghavi M, Murray C; Global Burden of Diseases, Injuries, and Risk Factors Study 2010 (GBD 2010) and the GBD Stroke Experts Group. Global and regional burden of stroke during 1990-2010: findings from the Global Burden of Disease Study 2010. Lancet. 2014 Jan 18;383(9913):245-54. Review. Erratum in: Lancet. 2014 Jan 18;383(9913):218. — View Citation

Kim BJ, Lee SH. Prognostic Impact of Cerebral Small Vessel Disease on Stroke Outcome. J Stroke. 2015 May;17(2):101-10. doi: 10.5853/jos.2015.17.2.101. Epub 2015 May 29. Review. — View Citation

Kim YJ, Kwon HK, Lee JM, Cho H, Kim HJ, Park HK, Jung NY, San Lee J, Lee J, Jang YK, Kim ST, Lee KH, Choe YS, Kim YJ, Na DL, Seo SW. Gray and white matter changes linking cerebral small vessel disease to gait disturbances. Neurology. 2016 Mar 29;86(13):1199-207. doi: 10.1212/WNL.0000000000002516. Epub 2016 Mar 2. — View Citation

Leary MC, Saver JL. Annual incidence of first silent stroke in the United States: a preliminary estimate. Cerebrovasc Dis. 2003;16(3):280-5. — View Citation

Maillard P, Carmichael O, Fletcher E, Reed B, Mungas D, DeCarli C. Coevolution of white matter hyperintensities and cognition in the elderly. Neurology. 2012 Jul 31;79(5):442-8. doi: 10.1212/WNL.0b013e3182617136. Epub 2012 Jul 18. — View Citation

Montero-Odasso MM, Sarquis-Adamson Y, Speechley M, Borrie MJ, Hachinski VC, Wells J, Riccio PM, Schapira M, Sejdic E, Camicioli RM, Bartha R, McIlroy WE, Muir-Hunter S. Association of Dual-Task Gait With Incident Dementia in Mild Cognitive Impairment: Results From the Gait and Brain Study. JAMA Neurol. 2017 Jul 1;74(7):857-865. doi: 10.1001/jamaneurol.2017.0643. Erratum in: JAMA Neurol. 2017 Nov 1;74(11):1381. — View Citation

Murray ME, Senjem ML, Petersen RC, Hollman JH, Preboske GM, Weigand SD, Knopman DS, Ferman TJ, Dickson DW, Jack CR Jr. Functional impact of white matter hyperintensities in cognitively normal elderly subjects. Arch Neurol. 2010 Nov;67(11):1379-85. doi: 10.1001/archneurol.2010.280. — View Citation

Poels MM, Steyerberg EW, Wieberdink RG, Hofman A, Koudstaal PJ, Ikram MA, Breteler MM. Assessment of cerebral small vessel disease predicts individual stroke risk. J Neurol Neurosurg Psychiatry. 2012 Dec;83(12):1174-9. doi: 10.1136/jnnp-2012-302381. Epub 2012 Aug 23. — View Citation

Sachdev PS, Wen W, Christensen H, Jorm AF. White matter hyperintensities are related to physical disability and poor motor function. J Neurol Neurosurg Psychiatry. 2005 Mar;76(3):362-7. — View Citation

Smith EE, Saposnik G, Biessels GJ, Doubal FN, Fornage M, Gorelick PB, Greenberg SM, Higashida RT, Kasner SE, Seshadri S; American Heart Association Stroke Council; Council on Cardiovascular Radiology and Intervention; Council on Functional Genomics and Translational Biology; and Council on Hypertension. Prevention of Stroke in Patients With Silent Cerebrovascular Disease: A Scientific Statement for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2017 Feb;48(2):e44-e71. doi: 10.1161/STR.0000000000000116. Epub 2016 Dec 15. Review. — View Citation

Verghese J, Lipton RB, Hall CB, Kuslansky G, Katz MJ, Buschke H. Abnormality of gait as a predictor of non-Alzheimer's dementia. N Engl J Med. 2002 Nov 28;347(22):1761-8. — View Citation

Vermeer SE, Hollander M, van Dijk EJ, Hofman A, Koudstaal PJ, Breteler MM; Rotterdam Scan Study. Silent brain infarcts and white matter lesions increase stroke risk in the general population: the Rotterdam Scan Study. Stroke. 2003 May;34(5):1126-9. Epub 2003 Apr 10. — View Citation

Vermeer SE, Longstreth WT Jr, Koudstaal PJ. Silent brain infarcts: a systematic review. Lancet Neurol. 2007 Jul;6(7):611-9. Review. — View Citation

Wakefield DB, Moscufo N, Guttmann CR, Kuchel GA, Kaplan RF, Pearlson G, Wolfson L. White matter hyperintensities predict functional decline in voiding, mobility, and cognition in older adults. J Am Geriatr Soc. 2010 Feb;58(2):275-81. doi: 10.1111/j.1532-5415.2009.02699.x. Epub 2010 Jan 26. — View Citation

Wardlaw JM, Smith EE, Biessels GJ, Cordonnier C, Fazekas F, Frayne R, Lindley RI, O'Brien JT, Barkhof F, Benavente OR, Black SE, Brayne C, Breteler M, Chabriat H, Decarli C, de Leeuw FE, Doubal F, Duering M, Fox NC, Greenberg S, Hachinski V, Kilimann I, Mok V, Oostenbrugge Rv, Pantoni L, Speck O, Stephan BC, Teipel S, Viswanathan A, Werring D, Chen C, Smith C, van Buchem M, Norrving B, Gorelick PB, Dichgans M; STandards for ReportIng Vascular changes on nEuroimaging (STRIVE v1). Neuroimaging standards for research into small vessel disease and its contribution to ageing and neurodegeneration. Lancet Neurol. 2013 Aug;12(8):822-38. doi: 10.1016/S1474-4422(13)70124-8. — View Citation

* Note: There are 19 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Change in cognitive assessment scale score(MMSE) It will be assessed by the Mini-Mental state examination (MMSE), which is scored 0-30. 1 year
Secondary Change in cognitive assessment scale score(MoCA) It will be assessed by the Montreal cognitive assessment (MoCA), which is scored 0-30. 1 year
Secondary the prevalence of gait disorders the prevalence of gait disorders, according to the intelligent assessment baseline
Secondary the prevalence of cognitive disorder the prevalence of cognitive disorder, according to the MMSE baseline
Secondary the incidence of vascular events the incidence of vascular events, including Cardiovascular and cerebrovascular events 1 year
Secondary the incidence of fall incidence the incidence of fall incidence 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT04449523 - Incidence of Silent Atrial Fibrillation in Patients With Clinically Silent Brain Ischemic Lesions
Completed NCT00831259 - Risk of Stroke in Pulmonary Embolism With a Patent Foramen Ovale (PFO) N/A
Recruiting NCT05369195 - Cerebral Protection in Transcatheter Left Atrial Appendage Occlusion N/A
Active, not recruiting NCT04808778 - Stroke Prevention in Young Adults With Sickle Cell Anemia
Completed NCT04241289 - Detection and Neurological Impact of Cerebrovascular Events in Cardiac Surgery Patients
Recruiting NCT05685069 - Prevalence of Attributable Etiology and Modifiable Stroke Risk Factors in Patients With Covert Brain Infarctions
Not yet recruiting NCT04457908 - The Effectiveness and Cost Effectiveness of Intelligent Assessment of Gait Disorder in Silent Cerebrovascular Disease N/A
Completed NCT04734587 - Evaluation of Brain Damage Due to Coronary Angioplasty in Percutaneous Intervention Patients
Completed NCT03104556 - Silent sTROke duriNG MitraClip Implantation