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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02540733

Enrollment

Registered

2015-09-04

Start date

2012-01-01

Completion date

2018-12-31

Last updated

2017-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Stroke, Diabetes Mellitus

Keywords

cerebral infarction, diabetes, rehabilitation, MRI

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
modified Rankin scale (mRS)	6 months	scores range from 0 (no symptoms) to 6 (dead)
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)

Countries

China

Contacts

Primary ContactMinming Zhang, PhD

zhangminming@zju.edu.cn86-0571-87315255

Outcome results