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

Traumatic Brain Injury Clinical Trial

— Plastim-MDTC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03513133
• Other study ID #: 2016-A00678-43
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2018
• Source: Centre d'Investigation Clinique et Technologique 805
• Contact: Philippe AZOUVI, MD-PhD
• Phone: 0033 147107074
• Email: philippe.azouvi[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Cognitive Dysfunction
• Cognitive Impairment
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
France	APHP Hôpital Raymond Poincaré	Garches	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Centre d'Investigation Clinique et Technologique 805

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	change from baseline to 3 months
Secondary	working memory testing	neuropsychological assessment of working memory	change from baseline to 3 months
Secondary	neuro-imaging changes	multimodal 3T MRI	change from baseline to 3 months