Five-day 20-minute 10-Hz tACS in Patients With a Disorder of Consciousness

NCT05833568 | Not Yet Recruiting

• 1 other identifier: 2021-2279
• Study Type: interventional
• Target: 138
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study first aims to validate the feasibility of a multimodal 5-day 20-minute tACS protocol in subacute brain-injured patients with a disorder of consciousness during their ICU stay, and conduct a clinical pilot study (validation phase). Upon completion of this validation phase and according to obtained results, a randomized clinical trial will be conducted to compare the effects of the 5-day active 10Hz-tACS protocol with a 5-day sham-tACS protocol on brain dynamics modulation. This study will also compare intervention conditions on recovery of consciousness, cognition and function using short-term and long-term measurements.

Conditions

Brain Injury Traumatic Severe; Disorder of Consciousness; Brain Injuries

Outcome Measures

Primary Outcomes (4)

• Single-site recruitment rates

  Quantify the frequency of recruitment in the entire study's protocol for the specific population in the Intensive Care Unit.

  1 year

• Retention rates

  Assess completion and participation in the entire study's from participants and their caregivers; for the intervention protocol as well as for longitudinal measures over time \[3,6,12 months\]

  over the 2-week course of the experimental protocol and at 3, 6 and 12 month time points

• Change in EEG spectral power of the alpha band activity

  EEG measures cortical electrical activity. Increase in the alpha band spectral power after the end of the 5-day 20-minute 10 Hz tACS intervention would indicate the specificity of the modulation's effect.

  It will be measured over the 2-week course of the experimental protocol

• Change in Functional Connectivity based on EEG signal

  Examine changes in the statistical relationship between specific electrophysiological signal parameters in time.

  It will be measured over the 2-week course of the experimental protocol

Secondary Outcomes (1)

• Changes in Coma Recovery Scale Revised (CRS-R) score throughout the protocol.

  It will be measured over the 2-week course of the experimental protocol

Other Outcomes (7)

• Monitor non-invasively changes in the pupillary light reflex across the protocol

  It will be measured over the 2-week course of the experimental protocol

• Monitor the recovery of wake-sleep cycles across the protocol

  It will be measured over the 2-week course of the experimental protocol

• Characterize pharmacological agents, dosage of the plasma expression of the glial fibrillary acidic protein (GFAP) and to isolate exosomes derived from neurons (EDNs), astrocytes (EDAs) and microglia (EDMs).

  Baseline measure (day 0)

Study Arms (2)

10-Hz tACS Stimulation Group

ACTIVE COMPARATOR

tACS stimulation will be delivered over to parieto-occipital sites using only 2-minute ramp up and down and a continuous 20-minute 10 Hz sinusoidal current administered. The stimulation electrode montage will be identical for both conditions.

Device: Active Transcranial alternative current stimulation

Sham Stimulation Group

SHAM COMPARATOR

Sham stimulation will be delivered over to parieto-occipital sites using only 2-minute ramp up and down, without any sinusoidal current administered for 20 minutes. The stimulation electrode montage will be identical for both conditions.

Device: SHAM Transcranial alternative current stimulation

Interventions

Active Transcranial alternative current stimulation DEVICE

GTEN 200 (Magstim-EGI, OREGON, USA). The current will be administered via an amplifier connected to an EEG system of 128-Channel Geodesic Sensor Net (Magstim-EGI, Oregon, USA) with sponge-based electrode nets. tACS stimulation will be applied for 20 minutes for 5 consecutive days via a bilateral electrode montage of 5 electrodes per hemisphere over parieto-occipital cortical sites. Specific stimulation electrodes for both conditions will be: \[right hemisphere: E83, E90, E96, E84, E91\] and for the \[left hemisphere: E58, E65, E70, E66, E59\]. The intensity of the applied alternative current (AC) will be a maximum of 1 mA peak-to-peak. The stimulation frequency will be adjusted to 10 Hz (median value of the alpha frequency band) for the tACS condition.

10-Hz tACS Stimulation Group

SHAM Transcranial alternative current stimulation DEVICE

GTEN 200 (Magstim-EGI, OREGON, USA). The current will be administered via an amplifier connected to an EEG system of 128-Channel Geodesic Sensor Net (Magstim-EGI, Oregon, USA) with sponge-based electrode nets. SHAM stimulation will be applied for a 2-minute ramp-up, then the current will stop for 20 minutes, followed by a 2-minute ramp-down. This will be applied for 5 consecutive days via a bilateral electrode montage of 5 electrodes per hemisphere over parieto-occipital cortical sites. Specific stimulation electrodes for both conditions will be: \[right hemisphere: E83, E90, E96, E84, E91\] and for the \[left hemisphere: E58, E65, E70, E66, E59\]. The intensity of the applied alternative current (AC) will be a maximum of 1 mA peak-to-peak. The stimulation frequency will be adjusted to 10 Hz (median value of the alpha frequency band) for the ramp-up and down in the SHAM conditions.

Sham Stimulation Group

Eligibility Criteria

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

You may qualify if:

• Adults ≥ 18 years old; Glasgow Coma Scale score remaining ≤ 12 following a minimum of 24 hours after the withdrawal of continuous sedation (if applicable).
• The included brain injury etiologies for the Unresponsive Wakefulness Syndrome(UWS) or Minimally Conscious State (MCS) are traumatic and non-traumatic (e.g., traumatic brain injury, anoxic brain injury, subarachnoid hemorrhage).

You may not qualify if:

• Focal brain lesion(s) in the occipital and parietal lobes located at stimulation site
• Pre-existing severe neurological conditions/disorders involving cognitive deficits such as neurodegenerative diseases (ALS, dementia, Parkinson's), hereditary conditions (e.g. Huntington's Chorea), CNS disorders (previous moderate-severe CBT)
• History of epilepsy (patient with a seizure episode in response to non-exclusive active tACS intervention)
• Aneurysm clip(s), subdural brain electrodes, metallic brain, an implant, implantable neurostimulator
• Craniectomy with no bone flap
• Cervical collar limiting access to the occipital region
• Participation in a current (or previous) study that may have a confounding effect, as assessed by the research team.

Sponsors & Collaborators

• Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal: lead
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator

Related Publications (2)

• Martens G, Lejeune N, O'Brien AT, Fregni F, Martial C, Wannez S, Laureys S, Thibaut A. Randomized controlled trial of home-based 4-week tDCS in chronic minimally conscious state. Brain Stimul. 2018 Sep-Oct;11(5):982-990. doi: 10.1016/j.brs.2018.04.021. Epub 2018 May 2.

  PMID: 29759943 BACKGROUND

• De Koninck BP, Brazeau D, Deshaies AA, Briand MM, Maschke C, Williams V, Arbour C, Williamson D, Duclos C, Bernard F, Blain-Moraes S, De Beaumont L. Modulation of brain activity in brain-injured patients with a disorder of consciousness in intensive care with repeated 10-Hz transcranial alternating current stimulation (tACS): a randomised controlled trial protocol. BMJ Open. 2024 Jul 11;14(7):e078281. doi: 10.1136/bmjopen-2023-078281.

  PMID: 38991682 DERIVED

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

Central Study Contacts

Louis De Beaumont, PhD

CONTACT

514-338-2222; louis.de.beaumont@umontreal.ca

Beatrice Pelletier-De Koninck, MSc

CONTACT

514-338-2222; beatrice.pelletier-de.koninck@umontreal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 27, 2023
• Study Start: September 1, 2023
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share