Prefontal tDCS in Patients With Disorders of Consciousness: Neurophysiological and Behavioural Outcomes

Disorder of Consciousness Clinical Trial

Official title:

Prefontal tDCS in Patients With Disorders of Consciousness: Neurophysiological and Behavioural Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03823508
• Other study ID #: 2013-296
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: July 2019
• Source: University of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Non-invasive brain stimulations techniques have recently shown promising results in patients with disorders. Notably, transcranial direct current stimulation (tDCS) applied over the left dorsolateral prefrontal cortex has proved to be effective in improving signs of consciousness in about 50% of patients in MCS either after a single stimulation or after repeated sessions. However, brain mechanisms underlying tDCS effects remain poorly understood. Here we aim to assess the effects of prefrontal tDCS on neurophysiological (i.e., electroencephalography - EEG - primary outcome) and behavioral (secondary outcome) measures in severely brain-injured patients with DOC.

Description:

Currently, therapeutic options for severely brain-injured patients with disorders of consciousness (DOC), including patients in unresponsive wakefulness syndrome (UWS) and minimally conscious state (MCS), are limited and still need to be improved to influence long-term outcomes. Non-invasive brain stimulations (NIBS) techniques have recently shown promising results in DOC. Notably, transcranial direct current stimulation (tDCS) applied over the left dorsolateral prefrontal cortex has proved to be effective in improving signs of consciousness in about 50% of patients in MCS either after a single stimulation or after repeated sessions. However, brain mechanisms underlying tDCS effects remain poorly understood.In the present protocol, the investigators will assess the effects of prefrontal tDCS on neurophysiological (i.e., electroencephalography - EEG - primary outcome) and behavioral (secondary outcome) measures in severely brain-injured patients with DOC in a double-blind sham-controlled design. One anodal and one sham tDCS will be delivered in a randomized order in chronic (>28 days post-onset) severely brain-damaged patients. The stimulation will have an intensity of 2 mA and will last 20 minutes. The anode will be placed on the left dorsolateral prefrontal cortex and the cathode on the right supraorbital region. Ten minutes of high-density EEG will be recorded using a 256-channel saline electrode net (Electrical Geodesics) directly before and after each tDCS session. Behavioral assessments will be performed using the Coma Recovery Scale-Revised before and after each session by an investigator blinded to the treatment allocation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

Inclusion Criteria:

• post-comatose patients

• patients in vegetative state/unresponsive wakefulness syndrome or in minimally conscious state

• patients with stable condition

• patients free of sedative drugs and Na+ or Ca++ blockers (e.g., carbamazepine) or NMDA receptor antagonist (e.g., dextromethorphan)

Exclusion Criteria:

• premorbid neurology antecedent

• patients in coma

• patients < 28 days after the acute brain injury

• patients with a metallic cerebral implant/a shunt

• cranioplasty

Related Conditions & MeSH terms

• Consciousness Disorders
• Disease
• Disorder of Consciousness
• Minimally Conscious State
• Persistent Vegetative State
• Vegetative State

Intervention

Device:
• anodal tDCS
Patients will receive anodal tDCS during 20 minutes preceded and followed by a behavioral assessment (Coma Recovery Scale Revised) and a high density EEG. The anode will be placed over F3 in order to stimulate the left dorsolateral prefrontal cortex and the cathode over the right supraorbital area.
• sham tDCS
Identical to anodal tDCS, except that the stimulation will be stopped after 15 seconds.

Locations

Country	Name	City	State
Belgium	University Hospital of Liege	Liege

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the CRS-R scores	CRS-R will be performed before and after tDCS (anodal and sham). Comparison of the treatment effect (CRS-R total score after tDCS minus before) between real and sham tDCS	Baseline and directly after the tDCS (20 minutes)
Secondary	Change in EEG	256 channels EEG will be record before and after tDCS to record potential cortical changes induce by the stimulation.	Baseline and directly after the tDCS (20 minutes)
Secondary	Change in the vigilance level	Ocular parameters will be record using glasses before and after tDCS to record potential change of the vigilance level	Baseline and directly after the tDCS (20 minutes)