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Rehabilitation of Working Memory and Brain Plasticity After Traumatic Brain Injury: Plastim-MDTC

Rehabilitation of Working Memory After Traumatic Brain Injury: Pilot Study of Brain Plasticity in Multimodal Advanced MRI

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03513133
Acronym
Plastim-MDTC
Enrollment
20
Registered
2018-05-01
Start date
2017-07-01
Completion date
2019-12-31
Last updated
2018-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Impairment, Traumatic Brain Injury

Keywords

working memory, cognitive rehabilitation, functional neuroimaging

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.

Interventions

BEHAVIORALworking 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.

Sponsors

Centre d'Investigation Clinique et Technologique 805
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
working memory questionnairechange from baseline to 3 monthsIt 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.

Secondary

MeasureTime frameDescription
working memory testingchange from baseline to 3 monthsneuropsychological assessment of working memory
neuro-imaging changeschange from baseline to 3 monthsmultimodal 3T MRI

Countries

France

Contacts

Primary ContactPhilippe AZOUVI, MD-PhD
philippe.azouvi@aphp.fr0033 147107074
Backup ContactErica VLACHOS, CRA
erica.vlachos@aphp.fr0033 147104472

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026