NCT03012269

Brief 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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

December 31, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 6, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Last Updated

January 6, 2017

Status Verified

January 1, 2017

Enrollment Period

6 years

First QC Date

December 31, 2016

Last Update Submit

January 4, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • The fluid intelligence measured by Raven's Standard Progressive Matrices (RSPM) test

    six weeks

  • Attention ability assessed by Stroop color-word test

    six weeks

Study Arms (2)

Working Memory Training

EXPERIMENTAL

The subjects of experimental group received a series of working memory training, 30 min for 5 days per week during 6 weeks.

Behavioral: Working memory training

Non-Working Memory Training

NO INTERVENTION

The subjects of control group performed traditional cognitive rehabilitation without working memory training, 30 min for 5 days per week during 6 weeks.

Interventions

Working Memory Training

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Aphasia, unilateral spatial neglect, agnosia, apraxia
  • Hearing impairment or visual impairment
  • History of taking psychiatric drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rehabilitation Evaluation, China Rehabilitation Research Center

Beijing, Beijing Municipality, 100068, China

RECRUITING

Study Officials

  • Xiaoping Yun, MD

    Department of Rehabilitation Evaluation, China Rehabilitation Research Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoping Yun, MD

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of Rehabilitation Evaluation

Study Record Dates

First Submitted

December 31, 2016

First Posted

January 6, 2017

Study Start

October 1, 2012

Primary Completion

October 1, 2018

Last Updated

January 6, 2017

Record last verified: 2017-01

Locations