Disorder of ConsciousnessNCT04401319
rTMS and EEG in DOC Patients
A study testing DLPFC Stimulation for Crossover Study, AG Stimulation for Crossover Study and DLPFC Stimulation for Parallel Study in people with Disorder of Consciousness, run by University of Liege at 2 sites in 2 countries.
Trial summary
Background: Severe brain injury could cause chronic disorders of consciousness (DOC). Treating DOC patients to improve recovery remains very challenging. A few randomized controlled studies have been published in the recent years, focusing on non-invasive brain stimulation (NIBS) treatments to improve patients'… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disorder of Consciousness
- What is being tested?
- DLPFC Stimulation for Crossover Study, AG Stimulation for Crossover Study and DLPFC Stimulation for Parallel Study
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2024to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 18 years old
- > 28 days post-injury
- patients with DOC due to acquired brain lesions classified according to international guidelines as UWS or MCS with repeated behavioural assessments with the CRS-R
- stable vital parameters
- no previous neurological deficits anterior to the brain lesions
- no pregnancy
Show all 10Show fewer
- no contraindication for rTMS or EEG (e.g., uncontrolled epilepsy, that is, seizure within 4 weeks prior to enrollment, metallic implant in the skull, pacemaker, craniotomy under the stimulated site, implanted brain device, sensitive skin)
- no sedative drugs and drugs thought to interfere with brain stimulation such as Na or Ca channel blockers (e.g., carbamazepine) or NMDA receptor antagonists (e.g., dextromethorphan)
- no drugs or substances which have strong potential of seizure induction (imipramine, amitriptyline, doxepin, nortriptyline, maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, amphetamines, cocaine, phencyclidine, ketamine, gamma-hydroxybutyrate, alcohol, and theophylline).
- All etiologies (e.g., trauma, stroke, and anoxia)
Who cannot join
- -
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Belgium1 site
University Hospital of Liège
Liège, 4000
Masachika Niimi, M.D., Ph.D., +32494999230, m.niimi@uliege.be
Olivia Gosseries, Ph.D., +3243663954, ogosseries@uliege.be
Germany1 site
Therapiezentrum Burgau
Burgau, 89331
Martin Rosenfelder, MSc, +498222404138, m.rosenfelder@therapiezentrum-burgau.de
Andreas Bender, M.D., Ph.D.
About this study
Official title: Repetitive Transcranial Magnetic Stimulation and Electroencephalography in Patients With Disorders of Consciousness
Background:
Severe brain injury could cause chronic disorders of consciousness (DOC). Treating DOC patients to improve recovery remains very challenging. A few randomized controlled studies have been published in the recent years, focusing on non-invasive brain stimulation (NIBS) treatments to improve patients' neurobehavioural functioning. Among NIBS, repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique that can modulate cortical excitability, enhance neural plasticity, and induce strong neuromodulatory effects that outlast the period of stimulation. It is thought to modulate cortical activity and could therefore be effective for treating DOC patients. Currently, there is no unified protocol for rTMS in DOC patients and studies vary in many aspects.
Read more
In this study, the investigators aim to improve the functional recovery of DOC patients following severe brain injury using rTMS in two multi-center double-blind studies.
Methods/design:
The investigators will recruit 90 DOC patients. Patients will have three rTMS sessions that will be randomized within patients in a crossover design: (i) one real stimulation on the left dorsolateral prefrontal cortex (DLPFC); (ii) one real stimulation on the left angular cortex (AG) and (iii) one sham stimulation. Sessions will be separated by at least 5 days washout period. Each stimulation session will last 20 minutes with a frequency of 20Hz (train duration: 4s; inter-train interval: 26s; 3200 pulses at 80% of the resting motor threshold - RMT). The RMT, i.e., the minimum stimulus intensity that generated a motor evoked potential response of at least 50μV at rest for 5 out of 10 trials, will be calculated for the stimulation target using single-pulses on the right abductor pollicis brevis muscle.
After an interval of one week, a parallel design study will begin. Ninety patients will be randomly divided in two experimental groups and one sham group (30 patients per group). Stimulation will be performed for 20 working days once a day with the same stimulation parameters as in the crossover study.
Primary outcome will be determined as behavioral response to treatment as measured using the Coma Recovery Scale - Revised (CRS-R). Resting-state high-density EEG will be also recorded to investigate the neurophysiological correlates by rTMS.
Discussion:
This study will contribute to define the role of rTMS for the treatment of DOC patients and characterise the neural correlates of its action. In addition, the investigators will define the responders' profile based on patients' characteristics and functional impairments and develop biomarkers of responsiveness using machine learning to categorize EEG signals according to clinical responsiveness to the treatment.
- Conditions
- Disorder of Consciousness
- Being tested
- Sham Stimulation for Crossover Study, DLPFC Stimulation for Crossover Study, AG Stimulation for Crossover Study, Sham Stimulation for Parallel Study, DLPFC Stimulation for Parallel Study
- Keywords
- disorders of consciousness, transcranial magnetic stimulation
- Medical subject headings
- Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham Stimulation for Crossover StudyDevice
Stimulation will be delivered on the dorsolateral prefrontal cortex (DLPFC) or the angular cortex (AG) using a sham coil for 20 minutes with a frequency of 20Hz (train duration: 4s; inter-train interval: 26s; 3200 pulses at 80% of the resting motor threshold ) in one session. A single session will be conducted.
DLPFC Stimulation for Crossover StudyDevice
Stimulation will be delivered on the left dorsolateral prefrontal cortex (DLPFC) using a real coil for 20 minutes with a frequency of 20Hz (train duration: 4s; inter-train interval: 26s; 3200 pulses at 80% of the resting motor threshold ) in one session. A single session will be conducted.
AG Stimulation for Crossover StudyDevice
Stimulation will be delivered on the left angular cortex (AG) using a real coil for 20 minutes with a frequency of 20Hz (train duration: 4s; inter-train interval: 26s; 3200 pulses at 80% of the resting motor threshold ) in one session. A single session will be conducted.
Sham Stimulation for Parallel StudyDevice
Stimulation will be delivered on the dorsolateral prefrontal cortex (DLPFC) or the angular cortex (AG) using a sham coil for 20 minutes with a frequency of 20Hz (train duration: 4s; inter-train interval: 26s; 3200 pulses at 80% of the resting motor threshold ) in one session. Twenty sessions will be conducted.
DLPFC Stimulation for Parallel StudyDevice
Stimulation will be delivered on the left dorsolateral prefrontal cortex (DLPFC) using a real coil for 20 minutes with a frequency of 20Hz (train duration: 4s; inter-train interval: 26s; 3200 pulses at 80% of the resting motor threshold ) in one session. Twenty sessions will be conducted.
AG Stimulation for Parallel StudyDevice
Stimulation will be delivered on the left angular cortex (AG) using a real coil for 20 minutes with a frequency of 20Hz (train duration: 4s; inter-train interval: 26s; 3200 pulses at 80% of the resting motor threshold ) in one session. Twenty sessions will be conducted.
| Study group | Role | What they receive |
|---|---|---|
| Sham Stimulation Group for Crossover Study (DLPFC + AG) | Sham comparator | Sham stimulation will be delivered on the dorsolateral prefrontal cortex (DLPFC) and on the angular cortex (AG) using a sham coil in the crossover study. Receives: Device: Sham Stimulation for Crossover Study |
| DLPFC Stimulation Group for Crossover Study | Active comparator | Real stimulation will be delivered on the left dorsolateral prefrontal cortex (DLPFC) using a real coil in the crossover study. Receives: Device: DLPFC Stimulation for Crossover Study |
| AG Stimulation Group for Crossover Study | Active comparator | Real stimulation will be delivered on the left angular cortex (AG) using a real coil in the crossover study. Receives: Device: AG Stimulation for Crossover Study |
| Sham Stimulation Group for Parallel Study (DLPFC + AG) | Sham comparator | Sham stimulation will be delivered on the dorsolateral prefrontal cortex (DLPFC) or on the angular cortex (AG) using a sham coil in the parallel study. Receives: Device: Sham Stimulation for Parallel Study |
| DLPFC Stimulation Group for Parallel Study | Active comparator | Real stimulation will be delivered on the left dorsolateral prefrontal cortex (DLPFC) using a real coil in the parallel study. Receives: Device: DLPFC Stimulation for Parallel Study |
| AG Stimulation Group for Parallel Study | Active comparator | Real stimulation will be delivered on the left angular cortex (AG) using a real coil in the parallel study. Receives: Device: AG Stimulation for Parallel Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Coma Recovery Scale - Revised for Crossover Study
The Coma Recovery Scale - Revised is a non-invasive behavioural examination. It contains 23 items hierarchically presented and divided in 6 sub-scales (auditory, visual, motor, oro-motor/verbal, communication and arousal). The score is based on presence or absence of behaviours in response to sensory stimulations. The quantitative score can be calculated by adding the best observed response in each sub-scale. The diagnosis is obtained from the quality of observed behaviours (e.g., the ability of visual tracking means that the patient is minimally conscious). The total score ranges between 0 and 23. Higher scores mean a better outcome.
Measured: immediately after each rTMS session
Change from Baseline Coma Recovery Scale - Revised for Parallel Study 1
The Coma Recovery Scale - Revised is a non-invasive behavioural examination. It contains 23 items hierarchically presented and divided in 6 sub-scales (auditory, visual, motor, oro-motor/verbal, communication and arousal). The score is based on presence or absence of behaviours in response to sensory stimulations. The quantitative score can be calculated by adding the best observed response in each sub-scale. The diagnosis is obtained from the quality of observed behaviours (e.g., the ability of visual tracking means that the patient is minimally conscious). The total score ranges between 0 and 23. Higher scores mean a better outcome.
Measured: immediately after the last rTMS session
Change from Baseline Coma Recovery Scale - Revised for Parallel Study 2
The Coma Recovery Scale - Revised is a non-invasive behavioural examination. It contains 23 items hierarchically presented and divided in 6 sub-scales (auditory, visual, motor, oro-motor/verbal, communication and arousal). The score is based on presence or absence of behaviours in response to sensory stimulations. The quantitative score can be calculated by adding the best observed response in each sub-scale. The diagnosis is obtained from the quality of observed behaviours (e.g., the ability of visual tracking means that the patient is minimally conscious). The total score ranges between 0 and 23. Higher scores mean a better outcome.
Measured: 1 week after the last rTMS session
Change from Baseline Coma Recovery Scale - Revised for Parallel Study 3
The Coma Recovery Scale - Revised is a non-invasive behavioural examination. It contains 23 items hierarchically presented and divided in 6 sub-scales (auditory, visual, motor, oro-motor/verbal, communication and arousal). The score is based on presence or absence of behaviours in response to sensory stimulations. The quantitative score can be calculated by adding the best observed response in each sub-scale. The diagnosis is obtained from the quality of observed behaviours (e.g., the ability of visual tracking means that the patient is minimally conscious). The total score ranges between 0 and 23. Higher scores mean a better outcome.
Measured: 2 week after the last rTMS session
Secondary outcomes (5)
Change from Baseline Resting-State EEG for Crossover Study 1
EEG will be collected using a high-density EEG. Fifteen minutes of resting state will be performed. Resting-state EEG complexity and connectivity analyses will be performed at the individual and group level. The investigators will compute spectral measures as well as cortical functional connectivity using median spectral connectivity and graph-theoretic topology metrics such as clustering coefficient, path length, modularity and participation coefficient.
Measured: during each rTMS session
Change from Baseline Resting-State EEG for Crossover Study 2
EEG will be collected using a high-density EEG. Fifteen minutes of resting state will be performed. Resting-state EEG complexity and connectivity analyses will be performed at the individual and group level. The investigators will compute spectral measures as well as cortical functional connectivity using median spectral connectivity and graph-theoretic topology metrics such as clustering coefficient, path length, modularity and participation coefficient.
Measured: immediately after each rTMS session
Change from Baseline Resting-State EEG for Parallel Study 1
EEG will be collected using a high-density EEG. Fifteen minutes of resting state will be performed. Resting-state EEG complexity and connectivity analyses will be performed at the individual and group level. The investigators will compute spectral measures as well as cortical functional connectivity using median spectral connectivity and graph-theoretic topology metrics such as clustering coefficient, path length, modularity and participation coefficient.
Measured: immediately after the last rTMS session
Change from Baseline Resting-State EEG for Parallel Study 2
EEG will be collected using a high-density EEG. Fifteen minutes of resting state will be performed. Resting-state EEG complexity and connectivity analyses will be performed at the individual and group level. The investigators will compute spectral measures as well as cortical functional connectivity using median spectral connectivity and graph-theoretic topology metrics such as clustering coefficient, path length, modularity and participation coefficient.
Measured: 1 week after the last rTMS session
Change from Baseline Resting-State EEG for Parallel Study 3
EEG will be collected using a high-density EEG. Fifteen minutes of resting state will be performed. Resting-state EEG complexity and connectivity analyses will be performed at the individual and group level. The investigators will compute spectral measures as well as cortical functional connectivity using median spectral connectivity and graph-theoretic topology metrics such as clustering coefficient, path length, modularity and participation coefficient.
Measured: 2 week after the last rTMS session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study startJul 2024 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Disorder of ConsciousnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- We will perform a 3 arm crossover trial. Subsequently, we will perform a longer protocol using a 3 arm parallel design.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Collaborators
- Therapiezentrum Burgau
- Responsible party
- Principal investigator, Olivia Gosseries, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04401319
- Sponsor's protocol ID
- B0201941888
- Status last verified
- Jun 2023
- First submitted
- 3 May 2020
- Last updated
- 12 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vitello MM, Rosenfelder MJ, Cardone P, Niimi M, Willacker L, Thibaut A, Lejeune N, Laureys S, Bender A, Gosseries O. A protocol for a multicenter randomized and personalized controlled trial using rTMS in patients with disorders of consciousness. Front Neurol. 2023 Jul 21;14:1216468. doi: 10.3389/fneur.2023.1216468. eCollection 2023.
PubMed 37545735
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation and Electroencephalography in Patients With Disorders of Consciousness
- ClinicalTrials.gov ID
- NCT04401319
- Acronym / sponsor ID
- B0201941888
- Conditions
- Disorder of Consciousness
- Keywords
- disorders of consciousness, transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Collaborators
- Therapiezentrum Burgau
- Study start
- Jul 2024 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 26 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Severe brain injury could cause chronic disorders of consciousness (DOC). Treating DOC patients to improve recovery remains very challenging. A few randomized controlled studies have been published in the recent years, focusing on non-invasive brain stimulation (NIBS) treatments to improve patients' neurobehavioural functioning. Among NIBS, repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique that can modulate cortical excitability, enhance neural plasticity, and induce strong neuromodulatory effects that outlast the period of stimulation. It is thought to modulate cortical activity and could therefore be effective for treating DOC patients. Currently, there is no unified protocol for rTMS in DOC patients and studies vary in many aspects.
In this study, the investigators aim to improve the functional recovery of DOC patients following severe brain injury using rTMS in two multi-center double-blind studies.
Methods/design:
The investigators will recruit 90 DOC patients. Patients will have three rTMS sessions that will be randomized within patients in a crossover design: (i) one real stimulation on the left dorsolateral prefrontal cortex (DLPFC); (ii) one real stimulation on the left angular cortex (AG) and (iii) one sham stimulation. Sessions will be separated by at least 5 days washout period. Each stimulation session will last 20 minutes with a frequency of 20Hz (train duration: 4s; inter-train interval: 26s; 3200 pulses at 80% of the resting motor threshold - RMT). The RMT, i.e., the minimum stimulus intensity that generated a motor evoked potential response of at least 50μV at rest for 5 out of 10 trials, will be calculated for the stimulation target using single-pulses on the right abductor pollicis brevis muscle.
After an interval of one week, a parallel design study will begin. Ninety patients will be randomly divided in two experimental groups and one sham group (30 patients per group). Stimulation will be performed for 20 working days once a day with the same stimulation parameters as in the crossover study.
Primary outcome will be determined as behavioral response to treatment as measured using the Coma Recovery Scale - Revised (CRS-R). Resting-state high-density EEG will be also recorded to investigate the neurophysiological correlates by rTMS.
Discussion:
This study will contribute to define the role of rTMS for the treatment of DOC patients and characterise the neural correlates of its action. In addition, the investigators will define the responders' profile based on patients' characteristics and functional impairments and develop biomarkers of responsiveness using machine learning to categorize EEG signals according to clinical responsiveness to the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
- Model description
- We will perform a 3 arm crossover trial. Subsequently, we will perform a longer protocol using a 3 arm parallel design.
| Arm | Type | Receives |
|---|---|---|
| Sham Stimulation Group for Crossover Study (DLPFC + AG) | Sham comparator | Device: Sham Stimulation for Crossover StudySham stimulation will be delivered on the dorsolateral prefrontal cortex (DLPFC) and on the angular cortex (AG) using a sham coil in the crossover study. |
| DLPFC Stimulation Group for Crossover Study | Active comparator | Device: DLPFC Stimulation for Crossover StudyReal stimulation will be delivered on the left dorsolateral prefrontal cortex (DLPFC) using a real coil in the crossover study. |
| AG Stimulation Group for Crossover Study | Active comparator | Device: AG Stimulation for Crossover StudyReal stimulation will be delivered on the left angular cortex (AG) using a real coil in the crossover study. |
| Sham Stimulation Group for Parallel Study (DLPFC + AG) | Sham comparator | Device: Sham Stimulation for Parallel StudySham stimulation will be delivered on the dorsolateral prefrontal cortex (DLPFC) or on the angular cortex (AG) using a sham coil in the parallel study. |
| DLPFC Stimulation Group for Parallel Study | Active comparator | Device: DLPFC Stimulation for Parallel StudyReal stimulation will be delivered on the left dorsolateral prefrontal cortex (DLPFC) using a real coil in the parallel study. |
| AG Stimulation Group for Parallel Study | Active comparator | Device: AG Stimulation for Parallel StudyReal stimulation will be delivered on the left angular cortex (AG) using a real coil in the parallel study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- over 18 years old
- > 28 days post-injury
- patients with DOC due to acquired brain lesions classified according to international guidelines as UWS or MCS with repeated behavioural assessments with the CRS-R
- stable vital parameters
- no previous neurological deficits anterior to the brain lesions
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sham Stimulation for Crossover StudyStimulation will be delivered on the dorsolateral prefrontal cortex (DLPFC) or the angular cortex (AG) using a sham coil for 20 minutes with a frequency of 20Hz (train duration: 4s; inter-train interval: 26s; 3200 pulses at 80% of the resting motor threshold ) in one session. A single session will be conducted. | Device | Sham Stimulation Group for Crossover Study (DLPFC + AG) |
| DLPFC Stimulation for Crossover StudyStimulation will be delivered on the left dorsolateral prefrontal cortex (DLPFC) using a real coil for 20 minutes with a frequency of 20Hz (train duration: 4s; inter-train interval: 26s; 3200 pulses at 80% of the resting motor threshold ) in one session. A single session will be conducted. | Device | DLPFC Stimulation Group for Crossover Study |
| AG Stimulation for Crossover StudyStimulation will be delivered on the left angular cortex (AG) using a real coil for 20 minutes with a frequency of 20Hz (train duration: 4s; inter-train interval: 26s; 3200 pulses at 80% of the resting motor threshold ) in one session. A single session will be conducted. | Device | AG Stimulation Group for Crossover Study |
| Sham Stimulation for Parallel StudyStimulation will be delivered on the dorsolateral prefrontal cortex (DLPFC) or the angular cortex (AG) using a sham coil for 20 minutes with a frequency of 20Hz (train duration: 4s; inter-train interval: 26s; 3200 pulses at 80% of the resting motor threshold ) in one session. Twenty sessions will be conducted. | Device | Sham Stimulation Group for Parallel Study (DLPFC + AG) |
| DLPFC Stimulation for Parallel StudyStimulation will be delivered on the left dorsolateral prefrontal cortex (DLPFC) using a real coil for 20 minutes with a frequency of 20Hz (train duration: 4s; inter-train interval: 26s; 3200 pulses at 80% of the resting motor threshold ) in one session. Twenty sessions will be conducted. | Device | DLPFC Stimulation Group for Parallel Study |
| AG Stimulation for Parallel StudyStimulation will be delivered on the left angular cortex (AG) using a real coil for 20 minutes with a frequency of 20Hz (train duration: 4s; inter-train interval: 26s; 3200 pulses at 80% of the resting motor threshold ) in one session. Twenty sessions will be conducted. | Device | AG Stimulation Group for Parallel Study |
Primary outcome
Change from Baseline Coma Recovery Scale - Revised for Crossover Study
Time frame: immediately after each rTMS session
The Coma Recovery Scale - Revised is a non-invasive behavioural examination. It contains 23 items hierarchically presented and divided in 6 sub-scales (auditory, visual, motor, oro-motor/verbal, communication and arousal). The score is based on presence or absence of behaviours in response to sensory stimulations. The quantitative score can be calculated by adding the best observed response in each sub-scale. The diagnosis is obtained from the quality of observed behaviours (e.g., the ability of visual tracking means that the patient is minimally conscious). The total score ranges between 0 and 23. Higher scores mean a better outcome.
Change from Baseline Coma Recovery Scale - Revised for Parallel Study 1
Time frame: immediately after the last rTMS session
The Coma Recovery Scale - Revised is a non-invasive behavioural examination. It contains 23 items hierarchically presented and divided in 6 sub-scales (auditory, visual, motor, oro-motor/verbal, communication and arousal). The score is based on presence or absence of behaviours in response to sensory stimulations. The quantitative score can be calculated by adding the best observed response in each sub-scale. The diagnosis is obtained from the quality of observed behaviours (e.g., the ability of visual tracking means that the patient is minimally conscious). The total score ranges between 0 and 23. Higher scores mean a better outcome.
Change from Baseline Coma Recovery Scale - Revised for Parallel Study 2
Time frame: 1 week after the last rTMS session
The Coma Recovery Scale - Revised is a non-invasive behavioural examination. It contains 23 items hierarchically presented and divided in 6 sub-scales (auditory, visual, motor, oro-motor/verbal, communication and arousal). The score is based on presence or absence of behaviours in response to sensory stimulations. The quantitative score can be calculated by adding the best observed response in each sub-scale. The diagnosis is obtained from the quality of observed behaviours (e.g., the ability of visual tracking means that the patient is minimally conscious). The total score ranges between 0 and 23. Higher scores mean a better outcome.
Change from Baseline Coma Recovery Scale - Revised for Parallel Study 3
Time frame: 2 week after the last rTMS session
The Coma Recovery Scale - Revised is a non-invasive behavioural examination. It contains 23 items hierarchically presented and divided in 6 sub-scales (auditory, visual, motor, oro-motor/verbal, communication and arousal). The score is based on presence or absence of behaviours in response to sensory stimulations. The quantitative score can be calculated by adding the best observed response in each sub-scale. The diagnosis is obtained from the quality of observed behaviours (e.g., the ability of visual tracking means that the patient is minimally conscious). The total score ranges between 0 and 23. Higher scores mean a better outcome.
5 secondary outcomes
Change from Baseline Resting-State EEG for Crossover Study 1
Time frame: during each rTMS session
Change from Baseline Resting-State EEG for Crossover Study 2
Time frame: immediately after each rTMS session
Change from Baseline Resting-State EEG for Parallel Study 1
Time frame: immediately after the last rTMS session
Change from Baseline Resting-State EEG for Parallel Study 2
Time frame: 1 week after the last rTMS session
Change from Baseline Resting-State EEG for Parallel Study 3
Time frame: 2 week after the last rTMS session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Derived from this study: PubMed 37545735Vitello MM, Rosenfelder MJ, Cardone P, Niimi M, Willacker L, Thibaut A, Lejeune N, Laureys S, Bender A, Gosseries O. A protocol for a multicenter randomized and personalized controlled trial using rTMS in patients with disorders of consciousness. Front Neurol. 2023 Jul 21;14:1216468. doi: 10.3389/fneur.2023.1216468. eCollection 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DLPFC Stimulation for Crossover Study, AG Stimulation for Crossover Study and DLPFC Stimulation for Parallel Study in people with Disorder of Consciousness, run by University of Liege at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Masachika Niimi, M.D., Ph.D. (+32494999230, m.niimi@uliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Coma Recovery Scale - Revised for Crossover Study (time frame: immediately after each rTMS session). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04401319, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.