Clinical Trials Logo

Clinical Trial Summary

The objective of this study is to show that the measurement of auditory and vibro-tactile evoked potentials, or the recording of the EEG signal during a motor imaging task, can be used in routine clinical situations to explore the state of consciousness of subjects in Non-responsive Awakening (or Chronic Vegetative State) or in Minimal Consciousness (or relational state) after a severe brain injury.

Assumptions :

- Correlation between patient response rates obtained with the brain-machine interface and their clinical consciousness score (Coma Recovery Scale Revised score)

- Differentiation of the parameters of the evoked potentials P300 between patients in a vegetative state and those in a state of minimal consciousness


Clinical Trial Description

this is a pilot study on information obtained using a medical device marketed in accordance with CE standards, multicentric and prospective.

The study participation consists of five assessments of the subjects' level of awareness. Each evaluation lasts a total of two hours.

Patients will be assessed in their rooms as follows:

- Clinical evaluation of consciousness by the Coma Recovery Scale Revised (CRS-R), a clinical scale considered as the "gold-standard". Duration 45 minutes (standard care in routine care)

- 15-minute break between the two evaluations.

- Paraclinical evaluation of consciousness by the brain-machine interface by measuring evoked potentials P300 auditory and vibrotactile and recording the EEG signal during a motor imaging task (imagine moving the right or left wrist). Duration 60 minutes.

Instructions are given to the subject via headphones, in French. For the analysis of the evoked potentials, vibrotactile stimuli are delivered to the wrists and ankle of the subject. For auditory evoked potentials, auditory stimuli are delivered by headphones. The volume can be changed.

These assessments that we will perform with the brain-machine interface are similar to the assessments and stimulation of awakening and awareness sessions performed by speech-language pathologists in the departments concerned (presentation of visual and auditory stimuli). CRS-R is used in routine care to assess patients' level of consciousness. There is no recommendation on the type of additional examination to be performed (neuroimaging, EEG, evoked potentials) or on their frequency for the evaluation of patients' consciousness at a distance from their initial brain injury.

Evaluation by the brain-machine interface in the room makes it possible to avoid transport to the complementary examination services (Medical Imaging Services, Neurological Functional Explorations) which cause fatigue (patient whose vigilance is fluctuating) which can make the complementary examination non-contributory. Patients are also not assessed at a date and time set by a complementary examination service and room assessment allows the patient to be assessed in the best conditions for him/her when he/she appears to be at his/her highest level of consciousness and rested (after consultation with the family and/or healthcare team).

Total duration of each session of a maximum of 2 hours, including the installation and uninstallation of the brain-machine interface.

Patients receive their usual treatment and continue to participate in rehabilitation. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03998930
Study type Interventional
Source Centre Hospitalier Universitaire de Nimes
Contact
Status Completed
Phase N/A
Start date March 6, 2018
Completion date August 21, 2018

See also
  Status Clinical Trial Phase
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Recruiting NCT03869138 - Alternative Therapies for Improving Physical Function in Individuals With Stroke N/A
Completed NCT04101695 - Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects N/A
Completed NCT04034069 - Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial N/A
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Completed NCT00391378 - Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS) N/A
Recruiting NCT06204744 - Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial N/A
Active, not recruiting NCT06043167 - Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
Active, not recruiting NCT04535479 - Dry Needling for Spasticity in Stroke N/A
Completed NCT03985761 - Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke N/A
Recruiting NCT00859885 - International PFO Consortium N/A
Recruiting NCT06034119 - Effects of Voluntary Adjustments During Walking in Participants Post-stroke N/A
Completed NCT03622411 - Tablet-based Aphasia Therapy in the Chronic Phase N/A
Completed NCT01662960 - Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke N/A
Recruiting NCT05854485 - Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke N/A
Active, not recruiting NCT05520528 - Impact of Group Participation on Adults With Aphasia N/A
Completed NCT03366129 - Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
Completed NCT03281590 - Stroke and Cerebrovascular Diseases Registry
Completed NCT05805748 - Serious Game Therapy in Neglect Patients N/A
Recruiting NCT05993221 - Deconstructing Post Stroke Hemiparesis