RehabilitationPhase 2/3WMTNCT03012269
The Neural Substrates for Working Memory Training
A Phase 2/3 study testing Working memory training in people with Rehabilitation and Working Memory, run by China Rehabilitation Research Center at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Rehabilitation, Working Memory
- What is being tested?
- Working memory training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Oct 2012to Oct 2018
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Aphasia, unilateral spatial neglect, agnosia, apraxia
- Hearing impairment or visual impairment
- History of taking psychiatric drugs
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Rehabilitation Evaluation, China Rehabilitation Research Center
Beijing, Beijing Municipality, 100068
Xiaoping Yun, MD, 8601067574465, xiaoping_yun@163.com
About this study
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
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.
- Conditions
- Rehabilitation, Working Memory
- Being tested
- Working memory training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Working memory trainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: six weeks
Secondary outcomes (2)
The fluid intelligence measured by Raven's Standard Progressive Matrices (RSPM) test
Measured: six weeks
Attention ability assessed by Stroop color-word test
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startOct 2012
- Primary completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Rehabilitation Research Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yun XiaoPing, China Rehabilitation Research Center
- Investigators
- Xiaoping Yun, MD, Principal investigator, Department of Rehabilitation Evaluation, China Rehabilitation Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03012269
- Sponsor's protocol ID
- NSFC-81272165
- Acronym
- WMT
- Status last verified
- Jan 2017
- First submitted
- 31 Dec 2016
- Last updated
- 6 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03012269
- Acronym / sponsor ID
- WMT / NSFC-81272165
- Conditions
- Rehabilitation, Working Memory
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- China Rehabilitation Research CenterOther government
- Study start
- Oct 2012
- Primary completion
- Oct 2018 (estimated)
- First posted
- 6 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Working Memory Training | Experimental | Behavioral: Working memory trainingThe subjects of experimental group received a series of working memory training, 30 min for 5 days per week during 6 weeks. |
| 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Aphasia, unilateral spatial neglect, agnosia, apraxia
- Hearing impairment or visual impairment
- History of taking psychiatric drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Working memory training | Behavioural | Working Memory Training |
Primary outcome
Training-induced brain activations during working memory tasks in fMRI
Time frame: six weeks
Training-induced increased and decreased brain activations (Number of voxels) during n-back verbal WM task compared to the pre-training baseline
2 secondary outcomes
The fluid intelligence measured by Raven's Standard Progressive Matrices (RSPM) test
Time frame: six weeks
Attention ability assessed by Stroop color-word test
Time frame: six weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoping Yun, MD principal investigator
Department of Rehabilitation Evaluation, China Rehabilitation Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Working memory training in people with Rehabilitation and Working Memory, run by China Rehabilitation Research Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoping Yun, MD (86-01067574465, xiaoping_yun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Training-induced brain activations during working memory tasks in fMRI (time frame: six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2017.