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Behavioural Intervention

taVNS for Disorders of Consciousness

N/A

Recruiting

Led By Aurore Thibaut, PhD

Research Sponsored by University of Liege

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cerebral damage of known etiology

State of consciousness: unresponsive wakefulness syndrome (UWS) and minimally conscious state (MCS) as defined by CRS-R performed during the screening period

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 min before the stimulation period and 15 min after the stimulation period.

Awards & highlights

Study Summary

This trial will test a new way to help people who are in a coma or have other disorders of consciousness. The treatment is called transcutaneous auricular vagal nerve stimulation, and it involves stimulating the vagus nerve through the ear. The trial will measure the effects of the treatment on patients' behavior and brain activity.

Who is the study for?

This trial is for adults over 18 who are in a persistent vegetative state or minimally conscious after a coma, with known brain injury causes. They must be within 7 to 90 days post-injury and have healthy skin at the ear area. A legal representative must consent. Those with severe heart conditions, previous neurological issues, pregnancy, active implants like pacemakers, or under heavy sedation cannot join.Check my eligibility

What is being tested?

The study tests transcutaneous auricular vagal nerve stimulation (taVNS) on patients with consciousness disorders after a coma. It's randomized: some get real taVNS; others get sham (fake) treatment. The main goal is to see if taVNS improves awareness levels using behavioral scales and brain wave monitoring.See study design

What are the potential side effects?

Since this involves non-invasive stimulation of the ear's nerves, side effects might include discomfort at the site of application or mild headaches. However, specific side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have brain damage with a known cause.

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My condition is either UWS or MCS as confirmed by a recent CRS-R test.

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My skin around the ears is healthy and undamaged.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 min before the stimulation period and 15 min after the stimulation period.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 min before the stimulation period and 15 min after the stimulation period.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 min before the stimulation period and 15 min after the stimulation period. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in CRS-R total score and index score

Secondary outcome measures

Change in EEG

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active taVNSActive Control1 Intervention

Patients will receive 5 days of transcutaneous auricular vagal nerve stimulation (taVNS) bilaterally, at the cymba conchae, the active localization. It will be preceded and followed by a clinical assessment (Coma Recovery Scale- Revised) and a neurophysiological assessment (128/256 channels EEG and electrocardiograph) the first and last day of stimulation.

Group II: Sham taVNSPlacebo Group1 Intervention

Patients will receive 5 days of transcutaneous auricular vagal nerve stimulation (taVNS) bilaterally, at the ear lobe, the sham localization. It will be preceded and followed by a clinical assessment (Coma Recovery Scale- Revised) and a neurophysiological assessment (128/256 channels EEG and electrocardiograph) the first and last day of stimulation.

0 / 4Eligibility criteria met

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Who is running the clinical trial?

University of LiegeLead Sponsor

261 Previous Clinical Trials

70,302 Total Patients Enrolled

6 Trials studying Minimally Conscious State

168 Patients Enrolled for Minimally Conscious State

Aurore Thibaut, PhDPrincipal InvestigatorUniversité de Liège

Media Library

taVNS (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04065386 — N/A

Minimally Conscious State Research Study Groups: Sham taVNS, Active taVNS

Minimally Conscious State Clinical Trial 2023: taVNS Highlights & Side Effects. Trial Name: NCT04065386 — N/A

taVNS (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04065386 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum capacity of individuals that can participate in this clinical trial?

"Affirmative. As per the records available on clinicaltrials.gov, this medical experiment is actively recruiting participants since its posting on February 9th 2022 and most recently updated on November 14th 2022. The trial aims to enroll 48 patients from a single site."

Answered by AI

Does this research endeavor allow for participants aged 40 and above?

"According to this study's eligibility requirements, potential participants must be 18 years of age and younger than 99."

Answered by AI

To what demographic is recruitment for this scientific experiment open?

"The requirements for taking part in this clinical experiment are age (between 18 and 99) and semi-consciousness. A maximum of 48 individuals will be allowed to join the trial."

Answered by AI

Are there any vacancies remaining in this study?

"According to clinicaltrials.gov, this medical experiment is still open for enrolment of patients. It was published on February 9th 2022 and the details have since been updated as recently as November 14th 2022."

Answered by AI

Recent research and studies

Neuromodulation: Technology at the Neural InterfaceJournal

Optimization of Transcutaneous Vagus Nerve Stimulation Using Functional MRI

Yakunina, Natalia, Sam Soo Kim, and Eui-Cheol Nam. 2017. “Optimization of Transcutaneous Vagus Nerve Stimulation Using Functional MRI”. Neuromodulation: Technology at the Neural Interface. Elsevier BV. doi:10.1111/ner.12541.

Brain StimulationJournal

Transcutaneous Auricular Vagus Nerve Stimulation in Disorders of Consciousness Monitored by Fmri: The First Case Report

Yu, Yu-tian, Yi Yang, Lu-bin Wang, Ji-liang Fang, Yuan-yuan Chen, Jiang-hong He, and Pei-jing Rong. 2017. “Transcutaneous Auricular Vagus Nerve Stimulation in Disorders of Consciousness Monitored by Fmri: The First Case Report”. Brain Stimulation. Elsevier BV. doi:10.1016/j.brs.2016.12.004.

clinicaltrials.govStudy

Transcutaneous Auricular Vagal Nerve Stimulation for Post-coma Patients With Disorders of Consciousness

Aurore Thibaut 2022. "Transcutaneous Auricular Vagal Nerve Stimulation for Post-coma Patients With Disorders of Consciousness". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04065386.