Quantitative Prognostic Analysis of Upper Limb Motor Dysfunction After Stroke

Stroke Clinical Trial

Official title:

The Prognostic Analysis of Upper Limb Motor Dysfunction After Stroke Based on Dynamic Connection of Motion Network

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05410054
• Other study ID #: 2022FXHEC-KY002
• Status: Not yet recruiting
• Start date: August 10, 2022
• Est. completion date: December 2025

Study information

• Verified date: August 2022
• Source: Fu Xing Hospital, Capital Medical University
• Contact: Ran Li
• Phone: +86 1810456890
• Email: liran817[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

30% - 66% of stroke survivors have upper limb dysfunction. Effective rehabilitation can improve the prognosis, but the rehabilitation resources are limited. How to evaluate the prognosis early and formulate an individualized rehabilitation plan based on realistic expectations is still inconclusive. The current research shows that some brain network changes are related to the recovery of motor function. The dynamic connection of multi-modal and spatio-temporal fusion of motor network is helpful to the prognosis analysis of upper limb dyskinesia after stroke. 178 stroke patients will be included in this project. Fugl-Meyer motor function scale (upper limb part) and Action Research Arm Test (ARAT) will be evaluated at enrollment, 1month/3month/6month after onset. According to the results, the groups with good prognosis and poor prognosis will be distinguished; blood oxygen level dependent imaging and diffusion tensor imaging will be collected at the same time to compare the similarities and differences of the function and structural connection of the motion network; the correlation between interhemispheric connection, intrahemispheric connection, cross network connection of motor network and prognosis will be analyzed, the clinical and imaging features of different prognosis will be extracted. This study can provide scientific data support for the prognosis analysis of upper limb dysfunction after stroke, the improvement of rehabilitation clinical decision-making and the optimization of rehabilitation resource allocation.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 178
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• First stroke with upper limb motor dysfunction, Stable condition; 18 =age=80 years old; The onset time was less than 3 weeks at the time of enrollment; Sign informed consent.

Exclusion Criteria:

• Stroke patients with intracranial infection, multi-system atrophy and other central nervous system diseases; Combined with severe aphasia, visual spatial neglect and other cognitive impairment; Untreated spasm (Ashworth = grade 2); Obvious joint contracture restricting the movement of upper limb; In vivo metal implants; Claustrophobia.

Related Conditions & MeSH terms

• Prognosis
• Rehabilitation; Tobacco Use
• Stroke
• Upper Extremity Dysfunction

Intervention

Other:
• no intervention
observational research

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fu Xing Hospital, Capital Medical University

References & Publications (11)

Backhaus W, Braaß H, Higgen FL, Gerloff C, Schulz R. Early parietofrontal network upregulation relates to future persistent deficits after severe stroke-a prospective cohort study. Brain Commun. 2021 May 4;3(2):fcab097. doi: 10.1093/braincomms/fcab097. eCollection 2021. — View Citation

Binder E, Leimbach M, Pool EM, Volz LJ, Eickhoff SB, Fink GR, Grefkes C. Cortical reorganization after motor stroke: A pilot study on differences between the upper and lower limbs. Hum Brain Mapp. 2021 Mar;42(4):1013-1033. doi: 10.1002/hbm.25275. Epub 2020 Nov 9. — View Citation

Hoonhorst MHJ, Nijland RHM, van den Berg PJS, Emmelot CH, Kollen BJ, Kwakkel G. Does Transcranial Magnetic Stimulation Have an Added Value to Clinical Assessment in Predicting Upper-Limb Function Very Early After Severe Stroke? Neurorehabil Neural Repair. 2018 Aug;32(8):682-690. doi: 10.1177/1545968318785044. Epub 2018 Jul 4. — View Citation

Lee J, Lee A, Kim H, Shin M, Yun SM, Jung Y, Chang WH, Kim YH. Different Brain Connectivity between Responders and Nonresponders to Dual-Mode Noninvasive Brain Stimulation over Bilateral Primary Motor Cortices in Stroke Patients. Neural Plast. 2019 Apr 7;2019:3826495. doi: 10.1155/2019/3826495. eCollection 2019. — View Citation

Lundquist CB, Nielsen JF, Arguissain FG, Brunner IC. Accuracy of the Upper Limb Prediction Algorithm PREP2 Applied 2 Weeks Poststroke: A Prospective Longitudinal Study. Neurorehabil Neural Repair. 2021 Jan;35(1):68-78. doi: 10.1177/1545968320971763. Epub 2020 Nov 20. — View Citation

Nazarova M, Kulikova S, Piradov MA, Limonova AS, Dobrynina LA, Konovalov RN, Novikov PA, Sehm B, Villringer A, Saltykova A, Nikulin VV. Multimodal Assessment of the Motor System in Patients With Chronic Ischemic Stroke. Stroke. 2021 Jan;52(1):241-249. doi: 10.1161/STROKEAHA.119.028832. Epub 2020 Dec 15. — View Citation

Puig J, Blasco G, Alberich-Bayarri A, Schlaug G, Deco G, Biarnes C, Navas-Martí M, Rivero M, Gich J, Figueras J, Torres C, Daunis-I-Estadella P, Oramas-Requejo CL, Serena J, Stinear CM, Kuceyeski A, Soriano-Mas C, Thomalla G, Essig M, Figley CR, Menon B, Demchuk A, Nael K, Wintermark M, Liebeskind DS, Pedraza S. Resting-State Functional Connectivity Magnetic Resonance Imaging and Outcome After Acute Stroke. Stroke. 2018 Oct;49(10):2353-2360. doi: 10.1161/STROKEAHA.118.021319. — View Citation

Simpson LA, Hayward KS, McPeake M, Field TS, Eng JJ. Challenges of Estimating Accurate Prevalence of Arm Weakness Early After Stroke. Neurorehabil Neural Repair. 2021 Oct;35(10):871-879. doi: 10.1177/15459683211028240. Epub 2021 Jul 28. — View Citation

Stinear CM, Byblow WD, Ackerley SJ, Smith MC, Borges VM, Barber PA. Proportional Motor Recovery After Stroke: Implications for Trial Design. Stroke. 2017 Mar;48(3):795-798. doi: 10.1161/STROKEAHA.116.016020. Epub 2017 Jan 31. — View Citation

Stinear CM. Prediction of motor recovery after stroke: advances in biomarkers. Lancet Neurol. 2017 Oct;16(10):826-836. doi: 10.1016/S1474-4422(17)30283-1. Epub 2017 Sep 12. Review. — View Citation

Xia Y, Huang G, Quan X, Qin Q, Li H, Xu C, Liang Z. Dynamic Structural and Functional Reorganizations Following Motor Stroke. Med Sci Monit. 2021 Mar 11;27:e929092. doi: 10.12659/MSM.929092. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor assessment at early subacute phase	Fugl-Meyer Assessment for Upper Limb	1 month after onset
Primary	Motor assessment at subacute phase	Fugl-Meyer Assessment for Upper Limb	3 months after onset
Primary	Motor assessment at chronic phase	Fugl-Meyer Assessment for Upper Limb	6 months after onset
Primary	Functional assessment at early subacute phase	Action Research Arm Test	1 month after onset
Primary	Functional assessment at subacute phase	Action Research Arm Test	3 months after onset
Primary	Functional assessment at chronic phase	Action Research Arm Test	6 months after onset
Primary	The motion network of early subacute phase with functional MRI	The structural and functional connection of the motion network	1 month after onset
Primary	The motion network of subacute phase with functional MRI	The structural and functional connection of the motion network	3 months after onset
Primary	The motion network of chronic phase with functional MRI	The structural and functional connection of the motion network	6 months after onset
Primary	Correlation analysis between changes of motor function and changes of motor network	The correlation between interhemispheric connection, intrahemispheric connection, cross network connection of motor network and motor function prognosis will be analyzed	1 month after onset, 3 months after onset, 6 months after onset