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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02540733
• Other study ID #: 81271530
• Status: Recruiting
• Phase: N/A
• First received: August 26, 2015
• Last updated: June 10, 2017
• Start date: January 1, 2012
• Est. completion date: December 31, 2018

Study information

• Verified date: June 2017
• Source: Zhejiang University
• Contact: Minming Zhang, PhD
• Phone: 86-0571-87315255
• Email: zhangminming[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. ?rst-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.

Related Conditions & MeSH terms

• Cerebral Infarction
• Cerebral Stroke
• Diabetes Mellitus
• Infarction
• Stroke

Locations

Country	Name	City	State
China	The 2nd Affiliated Hospital of Zhejiang University, School of Medicine,	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

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