Closed-loop tDCS in Patients in Minimally Conscious State

NCT03810079 | Completed

• 1 other identifier: 2015/251
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This research will test a closed-loop system using EEG-arousal measures (spectral entropy) to define the best moment of the day for application of transcranial direct current stimulation (tDCS) in patients in MCS This study aims at answering the following questions:

1. 1.Is tDCS applied during high vigilance states more effective in increasing the level of conscious awareness than low vigilance states in patients in minimally conscious state (MCS)?
2. 2.Is the EEG pattern (connectivity, complexity) different after application of active or sham tDCS at high vigilance or low vigilance states?
3. 3.Is there a difference in the profile of tDCS-responders as compared to non-responders with regards to etiology, clinical diagnosis (MCS+/MCS-), age, gender, time post-injury, functional outcome, structural and functional neuroimaging findings and EEG markers?

Conditions

Minimally Conscious State

Keywords

transcranial direct current stimulation; minimally conscious state; disorders of consciousness; non invasive brain stimulation; neuromodulation

Outcome Measures

Primary Outcomes (1)

• Change in EEG

  20 channels EEG will be continuously recorded to identify potential cortical changes induced by the stimulation.

  It will be measured throughout the 6 hour session and reported over the course of about 3 weeks

Secondary Outcomes (1)

• Change in the CRS-R total score

  It will be measured at the beginning of the 6 hour session for 30 minutes, at the end of the 6 hour session for 30 minutes and reported over the course of about 3 days

Study Arms (3)

Anodal tDCS High Vigilance

ACTIVE COMPARATOR

Patients will undergo continuous 20 channels EEG and receive anodal tDCS (bilateral prefrontal stimulation) at a pre-determined high level of EEG-derived spectral entropy during 20 minutes followed by a clinical assessment (Coma Recovery Scale-Revised)

Device: Anodal transcranial direct current stimulation

Anodal tDCS Low Vigilance

ACTIVE COMPARATOR

Patients will undergo continuous 20 channels EEG and receive anodal tDCS (bilateral prefrontal stimulation) at a pre-determined low level of EEG-derived spectral entropy during 20 minutes followed by a clinical assessment (Coma Recovery Scale-Revised)

Device: Anodal transcranial direct current stimulation

Anodal tDCS Random Vigilance

SHAM COMPARATOR

Patients will undergo continuous 20 channels EEG and receive tDCS (bilateral prefrontal stimulation) at a random level of EEG-derived spectral entropy during 20 minutes followed by a clinical assessment (Coma Recovery Scale-Revised)

Device: Anodal transcranial direct current stimulation

Interventions

Anodal transcranial direct current stimulation DEVICE

Neuromodulation of bilateral prefrontal areas using 2 mA tDCS delivered during 20 minutes via sponge electrodes on the scalp

Also known as: Anodal tDCS

Anodal tDCS High Vigilance; Anodal tDCS Low Vigilance; Anodal tDCS Random Vigilance

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• CNS medication stable for at least a week,
• Stable diagnosis of MCS (no diagnosis change based on 2 CRS-R performed within 1 week).
• Adult (16 years old - 75 years old)
• \> 28 days post injury

You may not qualify if:

• open craniotomies,
• VPS under the stimulated area (prefrontal cortex),
• pacemaker,
• metallic cerebral implant, according to safety criteria for transcranial electric stimulation,
• severe medical conditions that might influence clinical diagnosis and EEG activity (e.g., severe hepatic insufficiency or renal failure, or sub-continuous or abundant epileptiform discharges on standard EEG recordings).

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

University Hospital of Liege

Liège, Liege, 4000, Belgium

Location

MeSH Terms

Conditions

Persistent Vegetative State; Consciousness Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Unconsciousness; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Randomized double-blind sham-controlled crossover

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 18, 2019
• Study Start: August 1, 2019
• Primary Completion: December 21, 2024
• Study Completion: December 21, 2024
• Last Updated: May 6, 2026

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)