Clinical trial NCT03513133: Rehabilitation of Working Memory and Brain Plasticity After Traumatic Brain Injury: Plastim-MDTC
Official title: Rehabilitation of Working Memory After Traumatic Brain Injury: Pilot Study of Brain Plasticity in Multimodal Advanced MRI
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Traumatic Brain Injury
Cognitive Impairment
Keywords: working memory
cognitive rehabilitation
functional neuroimaging
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
First posted: 2018-05-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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
Primary purpose: TREATMENT

Brief 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)

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.

Eligibility criteria: Inclusion Criteria:

* moderate to severe traumatic brain injury
* 6 months or more after the injury
* working memory deficit on cognitive testing

Exclusion Criteria:

* previous neurological or psychiatric condition
* severe behavioral troubles
* contra-indication to MRI
* pregnancy

Primary outcomes:
measure: working memory questionnaire
timeFrame: change from baseline to 3 months
Secondary outcomes:
measure: working memory testing
timeFrame: change from baseline to 3 months
measure: neuro-imaging changes
timeFrame: change from baseline to 3 months
Other outcomes:
Locations:
city: Garches
country: France
facility: APHP Hôpital Raymond Poincaré
state: Ile De France
Study officials:
affiliation: APHP Hôpital Raymond Poincaré
name: Philippe AZOUVI, MD-PhD
role: STUDY_CHAIR
affiliation: Neurospin- CEA
name: Lucie HERTZ PANNIER, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital André Mignot
name: Eric BRUNET, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Paris 8
name: Claire Vallat-Azouvi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Vallat-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.
citation: Vallat-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.
citation: Vallat-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.