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NCT03012269 Clinical Trial

The Neural Substrates for Working Memory Training

Rehabilitation Clinical Trial

— WMT  

Official title:
The Study on the Brain Mechanisms for the Rehabilitation of Working Memory Deficits in Patients With Acquired Brain Injury Using Multimodal Magnetic Resonance Imaging

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03012269
Other study ID # NSFC-81272165
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received December 31, 2016
Last updated January 4, 2017
Start date October 2012

Study information
Verified date January 2017
Source China Rehabilitation Research Center
Contact Xiaoping Yun, MD
Phone 86-01067574465
Email xiaoping_yun@163.com
Is FDA regulated No
Health authority China: National Natural Science Foundation
Study type Interventional

Clinical Trial Summary

This study aims to conduct a contrast study on the characteristics of functional and structural connectivity of neural networks of working memory in patients with acquired brain injury versus normal controls, using resting-state functional connectivity magnetic resonance imaging, task-specific functional magnetic resonance imaging and diffusion tensor imaging, combined with cognitive behavioral examinations. Another purpose is to reveal the characteristics of dynamic change of neural networks of working memory pre- and post-intervention in patients with working memory dysfunction.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date
Est. primary completion date October 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- Right handedness

- Diagnosis of traumatic brain injury or stroke

- Course of disease within one year

- The score of MoCA test > 24

- Able to understand instructions

Exclusion Criteria:

- Aphasia, unilateral spatial neglect, agnosia, apraxia

- Hearing impairment or visual impairment

- History of taking psychiatric drugs

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• Working memory training

Locations
Country Name City State
China Department of Rehabilitation Evaluation, China Rehabilitation Research Center Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
China Rehabilitation Research Center

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Training-induced brain activations during working memory tasks in fMRI Training-induced increased and decreased brain activations (Number of voxels) during n-back verbal WM task compared to the pre-training baseline six weeks Yes
Secondary The fluid intelligence measured by Raven's Standard Progressive Matrices (RSPM) test six weeks No
Secondary Attention ability assessed by Stroop color-word test six weeks No
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