Traumatic Brain InjuryPlastim-MDTCNCT03513133
Rehabilitation of Working Memory and Brain Plasticity After Traumatic Brain Injury: Plastim-MDTC
A study testing working memory training in people with Traumatic Brain Injury and Cognitive Impairment, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
Trial summary
The aim of this study is to assess the brain correlates, as assessed with multimodal MRI, of working memory training in patients with severe traumatic brain injury (TBI) Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Cognitive Impairment
- 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
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2017to 31 Dec 2019
- Phase
- Interventional
- 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
- moderate to severe traumatic brain injury
- 6 months or more after the injury
- working memory deficit on cognitive testing
Who cannot join
- previous neurological or psychiatric condition
- severe behavioral troubles
- contra-indication to MRI
- pregnancy
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
APHP Hôpital Raymond Poincaré
Garches, Île-de-France Region, 92380
Philippe AZOUVI, MD-PhD, 0033 147107074, philippe.azouvi@aphp.fr
Erica VLACHOS, CRA, 0033 147104472, erica.vlachos@aphp.fr
About this study
Official title: Rehabilitation of Working Memory After Traumatic Brain Injury: Pilot Study of Brain Plasticity in Multimodal Advanced MRI
The aim of this study is to assess the brain correlates, as assessed with multimodal MRI, of working memory training in patients with severe traumatic brain injury (TBI)
Read the detailed description
This is a pilot feasibility study. Patients with subacute/chronic (> 6 months) severe TBI will be included if they suffer from a deficit in working memory. They will receive a specific hierarchical training of working memory (3 sessions per week during three months), according to a previously described methodology.
A multimodal MRI will be performed at neuroSpin center (CEA, Orsay, France) before and after cognitive training, including: structural imaging (T1, FLAIR and diffusion tensor imaging, DTI); functional connectivity at rest; and functional activation during a working memory task (n-back).
Behavioral and imaging changes after training will be analysed individually and compared to a group of healthy controls matched for age, gender and education.
- Conditions
- Traumatic Brain Injury, Cognitive Impairment
- Being tested
- working memory training
- Keywords
- working memory, cognitive rehabilitation, functional neuroimaging
- Medical subject headings
- Brain Injuries, Traumatic, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
working memory trainingBehavioural
Hierarchical cognitive training of the different components of working memory according to Baddeley model; 15 tasks are used addressing: the phonological loop (8 tasks), the visuospatial sketchpad (4 tasks) and the central executive 3 tasks). Task are given in a hierarchical order, according to each individual patient's deficits and improvement.
| Study group | Role | What they receive |
|---|---|---|
| working memory training | Experimental | Patients with severe TBI will receive a hierarchical training of working memory according to a previously described methodology. They will receive 3 sessions per week during three months (each session=1 h approximately) Receives: Behavioral: working memory training |
What is being measured
The primary outcome is the main question the study is designed to answer.
working memory questionnaire
It is a self-assessment questionnaire comprising 30 questions scored on a five-point Likert scale, ranging from 0 ("no problem at all") to 4 ("very severe problem in everyday life"). The total score will be used.
Measured: change from baseline to 3 months
Secondary outcomes (2)
working memory testing
neuropsychological assessment of working memory
Measured: change from baseline to 3 months
neuro-imaging changes
multimodal 3T MRI
Measured: change from baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start1 Jul 2017
- Primary completion1 Jul 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- a group of 10 patients with severe TBI will receive 3-month rehabilitation of working memory and will be compared to a group of 10 healthy controls
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe AZOUVI, MD-PhD, Study chair, APHP Hôpital Raymond PoincaréLucie HERTZ PANNIER, MD, Principal investigator, Neurospin- CEAEric BRUNET, MD, Principal investigator, Hôpital André MignotClaire Vallat-Azouvi, PhD, Principal investigator, University of Paris 8
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513133
- Sponsor's protocol ID
- 2016-A00678-43
- Acronym
- Plastim-MDTC
- Status last verified
- Feb 2018
- First submitted
- 19 Feb 2018
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vallat C, Azouvi P, Hardisson H, Meffert R, Tessier C, Pradat-Diehl P. Rehabilitation of verbal working memory after left hemisphere stroke. Brain Inj. 2005 Dec;19(13):1157-64. doi: 10.1080/02699050500110595.
PubMed 16286329Vallat-Azouvi C, Pradat-Diehl P, Azouvi P. The Working Memory Questionnaire: a scale to assess everyday life problems related to deficits of working memory in brain injured patients. Neuropsychol Rehabil. 2012;22(4):634-49. doi: 10.1080/09602011.2012.681110. Epub 2012 Apr 27.
PubMed 22537095Vallat-Azouvi C, Pradat-Diehl P, Azouvi P. Rehabilitation of the central executive of working memory after severe traumatic brain injury: two single-case studies. Brain Inj. 2009 Jun;23(6):585-94. doi: 10.1080/02699050902970711.
PubMed 19484632Vallat-Azouvi C, Pradat-Diehl P, Azouvi P. Modularity in rehabilitation of working memory: a single-case study. Neuropsychol Rehabil. 2014;24(2):220-37. doi: 10.1080/09602011.2014.881294. Epub 2014 Feb 19.
PubMed 24552571
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation of Working Memory After Traumatic Brain Injury: Pilot Study of Brain Plasticity in Multimodal Advanced MRI
- ClinicalTrials.gov ID
- NCT03513133
- Acronym / sponsor ID
- Plastim-MDTC / 2016-A00678-43
- Conditions
- Traumatic Brain Injury, Cognitive Impairment
- Keywords
- working memory, cognitive rehabilitation, functional neuroimaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre d'Investigation Clinique et Technologique 805University, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 1 May 2018 (actual)
- 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.
The aim of this study is to assess the brain correlates, as assessed with multimodal MRI, of working memory training in patients with severe traumatic brain injury (TBI)
Detailed description
This is a pilot feasibility study. Patients with subacute/chronic (> 6 months) severe TBI will be included if they suffer from a deficit in working memory. They will receive a specific hierarchical training of working memory (3 sessions per week during three months), according to a previously described methodology.
A multimodal MRI will be performed at neuroSpin center (CEA, Orsay, France) before and after cognitive training, including: structural imaging (T1, FLAIR and diffusion tensor imaging, DTI); functional connectivity at rest; and functional activation during a working memory task (n-back).
Behavioral and imaging changes after training will be analysed individually and compared to a group of healthy controls matched for age, gender and education.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- a group of 10 patients with severe TBI will receive 3-month rehabilitation of working memory and will be compared to a group of 10 healthy controls
| Arm | Type | Receives |
|---|---|---|
| working memory training | Experimental | Behavioral: working memory trainingPatients with severe TBI will receive a hierarchical training of working memory according to a previously described methodology. They will receive 3 sessions per week during three months (each session=1 h approximately) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- moderate to severe traumatic brain injury
- 6 months or more after the injury
- working memory deficit on cognitive testing
Key exclusion criteria (4 listed)
- previous neurological or psychiatric condition
- severe behavioral troubles
- contra-indication to MRI
- pregnancy
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 trainingHierarchical cognitive training of the different components of working memory according to Baddeley model; 15 tasks are used addressing: the phonological loop (8 tasks), the visuospatial sketchpad (4 tasks) and the central executive 3 tasks). Task are given in a hierarchical order, according to each individual patient's deficits and improvement. | Behavioural | working memory training |
Primary outcome
working memory questionnaire
Time frame: change from baseline to 3 months
It is a self-assessment questionnaire comprising 30 questions scored on a five-point Likert scale, ranging from 0 ("no problem at all") to 4 ("very severe problem in everyday life"). The total score will be used.
2 secondary outcomes
working memory testing
Time frame: change from baseline to 3 months
neuro-imaging changes
Time frame: change from baseline to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Background: PubMed 16286329Vallat C, Azouvi P, Hardisson H, Meffert R, Tessier C, Pradat-Diehl P. Rehabilitation of verbal working memory after left hemisphere stroke. Brain Inj. 2005 Dec;19(13):1157-64. doi: 10.1080/02699050500110595.
- Background: PubMed 22537095Vallat-Azouvi C, Pradat-Diehl P, Azouvi P. The Working Memory Questionnaire: a scale to assess everyday life problems related to deficits of working memory in brain injured patients. Neuropsychol Rehabil. 2012;22(4):634-49. doi: 10.1080/09602011.2012.681110. Epub 2012 Apr 27.
- Background: PubMed 19484632Vallat-Azouvi C, Pradat-Diehl P, Azouvi P. Rehabilitation of the central executive of working memory after severe traumatic brain injury: two single-case studies. Brain Inj. 2009 Jun;23(6):585-94. doi: 10.1080/02699050902970711.
- Background: PubMed 24552571Vallat-Azouvi C, Pradat-Diehl P, Azouvi P. Modularity in rehabilitation of working memory: a single-case study. Neuropsychol Rehabil. 2014;24(2):220-37. doi: 10.1080/09602011.2014.881294. Epub 2014 Feb 19.
- Individual participant dataSharing planned: No
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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.
Philippe AZOUVI, MD-PhD study chair
APHP Hôpital Raymond Poincaré
Lucie HERTZ PANNIER, MD principal investigator
Neurospin- CEA
Eric BRUNET, MD principal investigator
Hôpital André Mignot
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing working memory training in people with Traumatic Brain Injury and Cognitive Impairment, run by Centre d'Investigation Clinique et Technologique 805 at 1 site in France.
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 3 inclusion and 4 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 3 May 2018. 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 France. 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.
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 Philippe AZOUVI, MD-PhD (0033 147107074, philippe.azouvi@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
working memory questionnaire (time frame: change from baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03513133, which also lists 4 linked publications.
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 3 May 2018.