Sub-study of the NEURODOC Project : Neurophysiological Evaluation of a

Status Completed

Clinical Trial Summary

Clinical Trial Description

Limited treatments are available to improve consciousness in severely brain injured patients. Transcranial Direct Current stimulation (tDCS) is one of the few therapeutics that showed evidence of efficacy to increase level of consciousness and functional communication in some Minimally Conscious State (MCS) patients, and in some Vegetative State (VS) patients (1, 2, 3, 4), with no side effects reported.

However the mechanisms by which tDCS improves consciousness are poorly understood and the electrophysiological effects of the stimulation have never been studied in disorders of consciousness patients.

In this study, the investigators will use detailed clinical examinations (Coma Recovery Scale - Revised (5)) and electrophysiological assessments (quantitative high-density EEG and event-related potentials) (6, 7) and event-related potentials (8, 9) together with a standard morphological MRI to assess the effect of a open-label single session of left dorsolateral prefrontal cortex tDCS stimulation administered as routine care.

The primary goal is to investigate electrophysiological response to tDCS and its relation to behavioral response to better understand how tDCS affects consciousness in disorders of consciousness patients.

References:

1. Angelakis, E. et al. Transcranial Direct Current Stimulation Effects in Disorders of Consciousness. Arch. Phys. Med. Rehabil. 95, 283-289 (2014).

2. Thibaut, A., Bruno, M.-A., Ledoux, D., Demertzi, A. & Laureys, S. tDCS in patients with disorders of consciousness: sham-controlled randomized double-blind study. Neurology 82, 1112-1118 (2014).

3. Thibaut, A. et al. Controlled clinical trial of repeated prefrontal tDCS in patients with chronic minimally conscious state. Brain Inj. 1-9 (2017). doi:10.1080/02699052.2016.1274776

4. Martens, G. et al. Randomized controlled trial of home-based 4-week tDCS in chronic minimally conscious state. Brain Stimulat. (2018). doi:10.1016/j.brs.2018.04.021

5. Giacino, J. T. & Kalmar, K. Diagnostic and prognostic guidelines for the vegetative and minimally conscious states. Neuropsychol. Rehabil. 15, 166-174 (2005).

6. Sitt, J. D. et al. Large scale screening of neural signatures of consciousness in patients in a vegetative or minimally conscious state. Brain 137, 2258-2270 (2014).

7. Engemann, D. A. et al. Robust EEG-based cross-site and cross-protocol classification of states of consciousness. Brain J. Neurol. 141, 3179-3192 (2018).

8. Bekinschtein, T. A. et al. Neural signature of the conscious processing of auditory regularities. Proc. Natl. Acad. Sci. 106, 1672-1677 (2009).

9. Faugeras, F. et al. Event related potentials elicited by violations of auditory regularities in patients with impaired consciousness. Neuropsychologia 50, 403-418 (2012). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04035655
Study type	Interventional
Source	Groupe Hospitalier Pitie-Salpetriere
Contact
Status	Completed
Phase	N/A
Start date	October 2015
Completion date	September 2018

View Details

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	`NCT04034069` - Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial	N/A
Completed	`NCT04101695` - Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects	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	`NCT05621980` - Finger Movement Training After Stroke	N/A

Sub-study of the NEURODOC Project : Neurophysiological Evaluation of a Routine Care Open Label tDCS Session — Neurodoc

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms