CONsciousness Transcranial Electric STimulation

NCT03576248 | Terminated

• 2 other identifiers: C17-562017-A02763-50
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the effect of transcranial Alternating Current Stimulation (tACS) at theta frequency and the the effect of transcranial Direct Current Stimulation (tDCS) on the conscious state of non-communicating patients. tACS and tDCS are non-invasive stimulation techniques that are used to induce brain oscillations at certain frequency or to increase the brain activity in applied region. 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. However the optimal intensity of electrical current stimulation remains unknown and transcranial Alternative Current Stimulation (tACS), with the ability to stimulate cortex at specific frequencies and to manipulate phase-synchrony between regions is a promising techniques to improve patients' consciousness. In this study, the investigators will use prefrontal tDCS and theta tACS to improve patients consciousness level.

Conditions

Disorder of Consciousness

Keywords

State of consciousness; tACS; tDCS; Global neuronal workspace; Brain injury

Outcome Measures

Primary Outcomes (1)

• State of consciousness

  Change of the Coma Recovery Scale-Revised scores (CRS-R, Giacino et al. Neurology 2002 and Kalmar et al., Neuropsychol Rehabil 2005) between before and after stimulation (CRS-R post stimulation - CRS-R before stimulation). The CRS-R score is a qualitative and quantitative scales ranking predefined behaviors elicited by the patients in the following six subscales, auditory function, visual function, motor function, verbal and oromotor function, communication and wakefulness, the sum of which give a total score ranging from 0 to 23. Higher values of the scale mean a better state of consciousness. This change in state of consciousness will be compared between active stimulation and sham stimulation

  Two time points: immediately before (baseline) and immediately after stimulation (post-stimulation)

Secondary Outcomes (2)

• Evoked response potential during local-global paradigm

  Two time points: immediately before (baseline) and immediately after stimulation (post-stimulation)

• Resting state EEG

  Two time points: immediately before (baseline) and immediately after stimulation (post-stimulation)

Study Arms (4)

In-phase 6 Hz prefronto-parietal tACS

EXPERIMENTAL

6 Hz stimulation (1000 μA) with transcranial Alternative Current Stimulation (tACS) will be applied simultaneously over the left prefrontal dorso-lateral cortex (F3 of the 10-20 international scalp EEG system) and the left parietal cortex (P3 of the 10-20 international scalp EEG system, with a return electrode in Cz) for 20 minutes. The phase difference between the two stimulation sites will be 0°.

Device: In-phase 6 Hz prefronto-parietal tACS

Sham prefronto-parietal tACS

SHAM COMPARATOR

The same stimulation as in in-phase transcranial Alternative Current Stimulation tACS (6 Hz F3 and P3 stimulation with 0° phase difference) will start with a current intensity of 1000 μA lasting for 30 seconds. Afterwards, the intensity will progressively decrease over 20 seconds until cessation. The whole session duration is 20 minutes.

Device: Sham prefronto-parietal tACS

2 mA left prefrontal tDCS

EXPERIMENTAL

2000 μA anodal transcranial Direct Current Stimulation (tDCS) will be applied over the left prefrontal dorso-lateral cortex (F3 of the 10-20 international scalp EEG system with a right supraorbital return electrode (Fp2 of the 10-20 international scalp EEG system) during 20 minutes.

Device: 2 mA left prefrontal tDCS

Sham left prefrontal tDCS

SHAM COMPARATOR

The same stimulation as active transcranial Direct Current Stimulation (tDCS) (anodal F3 and return in Fp2) will start at 2 mA intensity for 30 seconds. Afterwards, the intensity will progressively decrease over 20 seconds until cessation. The whole session duration is 20 minutes.

Device: Sham left prefrontal tDCS

Interventions

In-phase 6 Hz prefronto-parietal tACS DEVICE

tACS is a non-invasive stimulation technique that works by delivering a weak sinusoidally oscillating electrical current to the surface of the skull to entrain oscillations in the brain.

In-phase 6 Hz prefronto-parietal tACS

Sham prefronto-parietal tACS DEVICE

tACS is a non-invasive stimulation technique that works by delivering a weak sinusoidally oscillating electrical current to the surface of the skull to entrain oscillations in the brain.

Sham prefronto-parietal tACS

2 mA left prefrontal tDCS DEVICE

tDCS is a form of neuromodulation method where very low levels of constant current are delivered to specifically targeted areas of the brain

2 mA left prefrontal tDCS

Sham left prefrontal tDCS DEVICE

tDCS is a form of neuromodulation method where very low levels of constant current are delivered to specifically targeted areas of the brain

Sham left prefrontal tDCS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 80 years
• Non communicative patients with disorder of consciousness diagnosed by CRS-R (VS, MCS, exitMCS)
• Patients with stable clinical examination (even in intensive care)
• Brain injury confirmed by cerebral imaging (MRI or TDM)
• French social security affiliation
• Signed and informed consent by the patient or by a legal representant

You may not qualify if:

• Status epilepticus or uncontrolled epilepsy
• Severely neurodegenerative illnesses (Alzheimer disease, Lewy Body Dementia)
• Electrical stimulation contraindication (metallic intra-cranial implants, pacemaker or implantable cardioverter-defibrillator, cranial prosthesis)
• Pregnant, parturient or breastfeeding women- Patients underage

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

Institut du Cerveau et de la Moelle - CR-ICM U 975 / UMRS INSERM 1127

Paris, 75013, France

Location

Related Publications (4)

• Thibaut A, Bruno MA, Ledoux D, Demertzi A, Laureys S. tDCS in patients with disorders of consciousness: sham-controlled randomized double-blind study. Neurology. 2014 Apr 1;82(13):1112-8. doi: 10.1212/WNL.0000000000000260. Epub 2014 Feb 26.

  PMID: 24574549 BACKGROUND

• Polania R, Nitsche MA, Korman C, Batsikadze G, Paulus W. The importance of timing in segregated theta phase-coupling for cognitive performance. Curr Biol. 2012 Jul 24;22(14):1314-8. doi: 10.1016/j.cub.2012.05.021. Epub 2012 Jun 7.

  PMID: 22683259 BACKGROUND

• Giacino JT, Ashwal S, Childs N, Cranford R, Jennett B, Katz DI, Kelly JP, Rosenberg JH, Whyte J, Zafonte RD, Zasler ND. The minimally conscious state: definition and diagnostic criteria. Neurology. 2002 Feb 12;58(3):349-53. doi: 10.1212/wnl.58.3.349.

  PMID: 11839831 BACKGROUND

• Kalmar K, Giacino JT. The JFK Coma Recovery Scale--Revised. Neuropsychol Rehabil. 2005 Jul-Sep;15(3-4):454-60. doi: 10.1080/09602010443000425.

  PMID: 16350986 BACKGROUND

MeSH Terms

Conditions

Consciousness Disorders; Brain Injuries

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jacobo D Sitt, MD, PhD

  CR-ICM U 975 /UMRS INSERM 1127

  PRINCIPAL INVESTIGATOR

• Lionel Naccache, MD, PhD

  CR-ICM U 975 /UMRS INSERM 1127

  PRINCIPAL INVESTIGATOR

• Bertrand Hermann, MD

  CR-ICM U 975 /UMRS INSERM 1127

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study will be double-blind : neither participant nor the investigator will know which stimulation type (in-phase active, anti-phase active or sham) is on.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This study is composed of two independent sub-studies, one exploring the effects of tACS and the other the effects of tDCS, with different participants assigned to the two sub-studies. There will be 2 arms in tACS group and 2 arms in tDCS group. Among each sub-study, all participants will participate in all arms (hence the cross-over design).

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: July 3, 2018
• Study Start: November 19, 2018
• Primary Completion: October 31, 2022
• Study Completion: January 3, 2024
• Last Updated: March 20, 2025

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)