MRI Study of the Structural and Functional Rehabilitation in the Cerebral Infarction Patients With Diabetes

• Conditions: Diabetes Mellitus; Cerebral Stroke

• Registration Number: NCT02540733
• Lead Sponsor: Zhejiang University

Brief Summary

Diabetes mellitus (DM) plays an important role in the occurrence of the cerebral infarction (CI). Clinical studies have demonstrated that the CI patients with DM had a poor prognosis compared with those without DM. Previous magnetic resonance imaging (MRI) studies have shown that patients with DM had abnormalities in cerebral vessels, nerves and functions, similar with the findings in mice models. In this study, with multi-modal MRI technologies, investigators tend to observe structural and functional changes of the brain in both DM and non-DM CI patients and assess their neural rehabilitation using clinical scales in the following 6 months. Investigators also expect to find out dynamic changes of brain structure and function, to reveal the weights of factors including brain blood vessels, nerves and function remodeling related with stroke recovery, as well as the potential mechanism in CI patients with DM.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-01
• Study First Submitted: 2015-08-26
• Study First Submitted QC: 2015-09-01
• Study First Posted: 2015-09-04
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-10
• Last Update Posted: 2017-06-14
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. first-ever ischemic stroke;
2. single infarct in the distribution of the middle cerebral artery;
3. no evidence of hemorrhagic infarction;
4. age greater than 18 years;
5. admission between 3 and 7 days after stroke onset;
6. National Institute of Health Stroke Score (NIHSS) score of 4 to 21 on admission and
7. no thrombolytic or recanalization therapies.

Exclusion Criteria

1. atrial fibrillation;
2. history of neurological or psychiatric disorders;
3. pre-stroke modified Rankin scale (mRS) > 1;
4. life expectancy < 1 year.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
National Institute of Health Stroke Score	6 months	scores ranging from 0 to 42 (the higher the score, the greater the function deficits)
Barthel index	6 months	score ranging from 0 (totally dependent) to 100 (completely independent)
modified Rankin scale (mRS)	6 months	scores range from 0 (no symptoms) to 6 (dead)

Trial Locations

Locations (1)

The 2nd Affiliated Hospital of Zhejiang University, School of Medicine,; 🇨🇳 Hangzhou, Zhejiang, China