Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02698449
Other study ID # RC31/14/7328
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 24, 2017
Est. completion date December 2023

Study information

Verified date March 2023
Source University Hospital, Toulouse
Contact Jérémie Pariente, PhD
Phone (0)5.61.77.95.02
Email pariente.j@chu-toulouse.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The current study aims to better understand cerebral plasticity mechanisms to optimize non-pharmacological rehabilitation approaches for patients with traumatic brain injury.


Description:

Cognitive impairment following moderate to severe traumatic brain injury are usual. To date, cognitive rehabilitation effects on cerebral plasticity and quality of life remain unproven essentially because of methodological biases. Transcranial Direct Current Stimulation is an innovative technique of noninvasive brain stimulation that showed efficacy in literature. The current study want to better understand cerebral plasticity mechanisms to optimize non-pharmacological rehabilitation approaches for patients with traumatic brain injury. The aim in the present study is to assess the effect of rehabilitation combined with Transcranial Direct Current Stimulation provided to traumatic brain injury patients with cognitive impairment on cerebral plasticity using functional magnetic resonance imaging. Effects of rehabilitation and Transcranial Direct Current Stimulation will be observed on functional magnetic resonance imaging activation maps acquired. Relationship between attentional outcomes measured in the neuropsychological assessment and activation extend will be explored.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 2023
Est. primary completion date July 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Moderate to severe traumatic brain injury - more than 3 months since the onset - Attentional disorders (PASAT test (score = centile 10) and/or CANTAB test (= -2 standard deviation) - Women having contraceptive treatment (for the magnetic resonance imaging exam) Exclusion Criteria: - inability to undergo magnetic resonance imaging scan - No attentional impairment (PASAT = centile10) - Severe depression - Neurological disease - Major cognitive impairment (aphasia, neglect) - Drugs addiction - Pregnant women and women having no contraceptive treatment

Study Design


Intervention

Procedure:
transcranial direct current stimulation
intensity provided will be 2 milliampere during 20 minutes using 2 electrodes (7x5cm). Anode electrode will be located on the right prefrontal dorsolateral area; cathode electrode will be located on the left supraorbital area.
Specific cognitive rehabilitation
Specific cognitive rehabilitation will be personalized regarding the cognitive complaint and will include a training part and an ecological part.
Nonspecific cognitive rehabilitation
Nonspecific cognitive rehabilitation will be focused on representation of body in space.
transcranial direct current stimulation sham
the same operation that transcranial direct current stimulating but it is a sham surgery
Radiation:
functional Magnetic Resonance Imaging n-back task
the n-back cognitive task was developed : 3 runs will be provided (0-back, 1-back and 2-back), each will be composed of 8 activation blocks and 8 resting blocks alternatively presented.

Locations

Country Name City State
France CHU Toulouse Toulouse

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Toulouse Fondation de l'Avenir

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary intergroup difference on cerebral map activation in functional magnetic resonance imaging (N-back task). 12 weeks
Secondary Intergroup differences in resting activation maps. 12 weeks
Secondary Intergroup differences in diffusion measures 12 weeks
Secondary Intergroup differences in neuropsychological score 12 weeks
Secondary Correlation between activation extend and attentional outcomes 12 weeks
Secondary Intergroup differences in polymorphisms 12 weeks
See also
  Status Clinical Trial Phase
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Recruiting NCT05503316 - The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System N/A
Completed NCT04356963 - Adjunct VR Pain Management in Acute Brain Injury N/A
Completed NCT03418129 - Neuromodulatory Treatments for Pain Management in TBI N/A
Terminated NCT03698747 - Myelin Imaging in Concussed High School Football Players
Recruiting NCT05130658 - Study to Improve Ambulation in Individuals With TBI Using Virtual Reality -Based Treadmill Training N/A
Recruiting NCT04560946 - Personalized, Augmented Cognitive Training (PACT) for Service Members and Veterans With a History of TBI N/A
Completed NCT05160194 - Gaining Real-Life Skills Over the Web N/A
Recruiting NCT02059941 - Managing Severe Traumatic Brain Injury (TBI) Without Intracranial Pressure Monitoring (ICP) Monitoring Guidelines N/A
Recruiting NCT03940443 - Differences in Mortality and Morbidity in Patients Suffering a Time-critical Condition Between GEMS and HEMS
Recruiting NCT03937947 - Traumatic Brain Injury Associated Radiological DVT Incidence and Significance Study
Completed NCT04465019 - Exoskeleton Rehabilitation on TBI
Recruiting NCT04530955 - Transitioning to a Valve-Gated Intrathecal Drug Delivery System (IDDS) N/A
Recruiting NCT03899532 - Remote Ischemic Conditioning in Traumatic Brain Injury N/A
Suspended NCT04244058 - Changes in Glutamatergic Neurotransmission of Severe TBI Patients Early Phase 1
Completed NCT03307070 - Adapted Cognitive Behavioral Treatment for Depression in Patients With Moderate to Severe Traumatic Brain Injury N/A
Recruiting NCT04274777 - The Relationship Between Lipid Peroxidation Products From Traumatic Brain Injury and Secondary Coagulation Disorders
Withdrawn NCT05062148 - Fundamental and Applied Concussion Recovery Modality Research and Development: Applications for the Enhanced Recovery N/A
Withdrawn NCT04199130 - Cognitive Rehabilitation and Brain Activity of Attention-Control Impairment in TBI N/A
Withdrawn NCT03626727 - Evaluation of the Efficacy of Sodium Oxybate (Xyrem®) in Treatment of Post-traumatic Narcolepsy and Post-traumatic Hypersomnia Early Phase 1