Rehabilitation of Working Memory and Brain Plasticity After Traumatic Brain Injury: Plastim-MDTC (Plastim-MDTC)
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|ClinicalTrials.gov Identifier: NCT03513133|
Recruitment Status : Recruiting
First Posted : May 1, 2018
Last Update Posted : May 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury Cognitive Impairment||Behavioral: working memory training||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention 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)|
|Official Title:||Rehabilitation of Working Memory After Traumatic Brain Injury: Pilot Study of Brain Plasticity in Multimodal Advanced MRI|
|Actual Study Start Date :||July 1, 2017|
|Estimated Primary Completion Date :||July 1, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: working memory training
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)
Behavioral: working memory training
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.
- 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.
- working memory testing [ Time Frame: change from baseline to 3 months ]neuropsychological assessment of working memory
- neuro-imaging changes [ Time Frame: change from baseline to 3 months ]multimodal 3T MRI
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03513133
|Contact: Philippe AZOUVI, MD-PhD||0033 firstname.lastname@example.org|
|Contact: Erica VLACHOS, CRA||0033 email@example.com|
|APHP Hôpital Raymond Poincaré||Recruiting|
|Garches, Ile De France, France, 92380|
|Contact: Philippe AZOUVI, MD-PhD 0033 147107074 firstname.lastname@example.org|
|Contact: Erica VLACHOS, CRA 0033 147104472 email@example.com|
|Study Chair:||Philippe AZOUVI, MD-PhD||APHP Hôpital Raymond Poincaré|
|Principal Investigator:||Lucie HERTZ PANNIER, MD||Neurospin- CEA|
|Principal Investigator:||Eric BRUNET, MD||Hôpital André Mignot|
|Principal Investigator:||Claire Vallat-Azouvi, PhD||University of Paris 8|