Disorder of ConsciousnessNCT07874178
Temporal Interference Stimulation for Disorders of Consciousness
A study testing Temporal Interference in people with Disorder of Consciousness and Minimally Conscious State, run by Centre Hospitalier Universitaire de Liege.
Trial summary
This study aims to investigate whether a new non-invasive brain stimulation technique, called temporal interference stimulation, can influence brain activity and potentially improve signs of consciousness in patients with severe brain injuries and disorders of consciousness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disorder of Consciousness, Minimally Conscious State, Vegetative State
- What is being tested?
- Temporal Interference
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥18 years.
- Diagnosis of unresponsive wakefulness syndrome or minimally conscious state confirmed by at least two Coma Recovery Scale-Revised (CRS-R) assessments.
- More than 28 days after the brain injury.
- Acquired brain injury of known etiology, including: Traumatic brain injury; Isolated intracranial hemorrhage (including subarachnoid, subdural, epidural, intracerebral, or iatrogenic hemorrhage); Stroke of any etiology; Cerebral anoxia/hypoxia (e.g., following cardiac arrest, drowning, choking, or drug overdose); Other acquired brain injuries (e.g., infectious encephalitis, carbon monoxide poisoning, or chemical/solvent inhalation).
- Available structural brain MRI.
- Medically stable.
- Written informed consent provided by the participant's legally authorized representative.
Who cannot join
- History of neurological or psychiatric disorder prior to the brain injury.
- Pregnancy (excluded based on medical records or a pregnancy test, if applicable).
- Presence of active brain implants and/or intracranial metallic implants.
- Uncontrolled epilepsy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Temporal Interference Stimulation in Patients With Severe Acquired Brain Injury and Disorders of Consciousness
This study aims to investigate whether a new non-invasive brain stimulation technique, called temporal interference stimulation, can influence brain activity and potentially improve signs of consciousness in patients with severe brain injuries and disorders of consciousness.
After a severe brain injury, some patients may remain unable to communicate or interact normally with their environment because of impaired consciousness. Current treatment options to promote recovery are limited. Temporal interference stimulation is a new technique that uses mild electrical currents applied through electrodes placed on the scalp to target specific areas deep inside the brain without surgery.
Read more
In this study, we will use brain imaging data to personalize the stimulation and target a region involved in consciousness regulation, called the thalamus. The effects of the stimulation will be evaluated using brain activity recordings, heart monitoring, and clinical assessments of consciousness and responses to stimulation.
The goal of this research is to determine whether temporal interference stimulation is safe and whether it can produce measurable changes in brain function and behavior in patients with disorders of consciousness. The results may help guide future research on new treatments for recovery after severe brain injury.
Read the detailed description
This open-label pilot study investigates the feasibility and potential neurophysiological and behavioral effects of MRI-guided temporal interference (TI) stimulation targeting the bilateral thalamus in patients with prolonged disorders of consciousness following severe acquired brain injury.
Severe brain injuries can disrupt the neural networks responsible for consciousness, particularly the interactions between the thalamus, basal ganglia, and cortical regions. The mesocircuit model suggests that impaired thalamocortical activation contributes to reduced consciousness after brain injury. While invasive approaches such as deep brain stimulation have shown potential benefits in selected patients, their clinical use is limited by surgical risks and technical constraints. Temporal interference stimulation represents a novel non-invasive neuromodulation approach designed to selectively influence deep brain structures while limiting stimulation of surrounding tissues.
During the study, individualized stimulation parameters will be determined using the patient's structural magnetic resonance imaging data. Computational modeling will be used to optimize electrode placement and electric field distribution in order to target the thalamic region. Stimulation will be delivered through transcranial electrodes placed on the scalp using two high-frequency electrical currents with slightly different frequencies. The interaction between these currents generates a low-frequency modulation at the target region, allowing selective modulation of deep neural structures.
Participants will undergo repeated TI stimulation sessions, with neurophysiological monitoring performed using high-density electroencephalography (127 electrodes) and electrocardiography before and after selected stimulation sessions. Behavioral changes associated with consciousness and responses to stimulation will be assessed using standardized clinical evaluations designed for patients with disorders of consciousness.
The study will also monitor the tolerability and safety of the intervention through continuous observation and systematic recording of potential adverse events. Previous studies of non-invasive brain stimulation techniques have demonstrated favorable safety profiles, with mainly mild and transient effects reported. This investigation aims to provide preliminary evidence regarding the capacity of temporal interference stimulation to modulate brain activity and potentially promote recovery-related changes in patients with severe disorders of consciousness.
- Conditions
- Disorder of Consciousness, Minimally Conscious State, Vegetative State, Unresponsive Wakefulness Syndrome, Brain Injury
- Being tested
- Temporal Interference
- Keywords
- Disorders of consciousness, Traumatic brain injury, Unresponsive wakefulness syndrome, Minimally conscious state, Temporal interference stimulation, Non-invasive brain stimulation, Neurorehabilitation
- Medical subject headings
- Consciousness Disorders, Persistent Vegetative State, Brain Injuries, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporal InterferenceDevice
Participants in the experimental arm will receive bilateral MRI-guided temporal interference (TI) stimulation targeting the thalami bilaterally. The stimulation will be delivered non-invasively through electrodes placed on the scalp. High-frequency electrical currents with slightly different frequencies will be applied simultaneously to generate a low- frequency modulation at the targeted brain region, allowing selective modulation of thalamic activity.
| Study group | Role | What they receive |
|---|---|---|
| Temporal Interference Stimulation | Experimental | Temporal interference stimulation is a non-invasive neuromodulation technique that uses overlapping electrical fields generated by scalp electrodes to selectively influence activity in deep brain regions. Receives: Device: Temporal Interference |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coma Recovery Scale - revised (CRS-r)
The Coma Recovery Scale-Revised (CRS-R, minimum score: 0; maximum score: 23, with higher scores indicating a higher level of responsiveness) is a standardized clinical assessment tool used to evaluate levels of consciousness and detect signs of recovery in patients with disorders of consciousness.
Measured: Immediately before and after the first stimulation session (Day 1); immediately after the third stimulation session (Day 3); Immediately before and after the last stimulation session, (Day 5); 1-week follow-up
Secondary outcomes (7)
Changes in EEG alpha-band power
Electroencephalographic (EEG) alpha-band power will be assessed during resting-state EEG recording. An increase in alpha-band power is expected following the intervention.
Measured: Immediately before and after the first stimulation session (Day 1); Immediately before and after the last stimulation session (Day 5)
Changes in EEG theta-band power
Electroencephalographic (EEG) theta-band power will be assessed during resting-state EEG recording. An increase in theta-band power is expected following the intervention.
Measured: Immediately before and after the first stimulation session (Day 1); Immediately before and after the last stimulation session (Day 5)
Changes in EEG delta-band power
Electroencephalographic (EEG) delta-band power will be assessed during resting-state EEG recording. A decrease in delta-band power is expected following the intervention.
Measured: Immediately before and after the first stimulation session (Day 1); Immediately before and after the last stimulation session (Day 5)
Changes in EEG spectral profile according to the ABCD model
The EEG spectral profile will be characterized according to the ABCD model of dynamic brain states using resting-state EEG recordings to assess changes in spectral characteristics following the intervention.
Measured: Immediately before and after the first stimulation session (Day 1); Immediately before and after the last stimulation session
Changes in alpha-band functional connectivity
Alpha-band cortical functional connectivity will be assessed from resting-state EEG recordings using graph theory-based analyses to characterize changes in functional connectivity following the intervention
Measured: Immediately before and after the first stimulation session (Day 1); Immediately before and after the last stimulation session (Day 5)
Heart rate
Heart rate will be recorded using electrocardiography simultaneously to the EEG recording. Electrocardiography (ECG) is a non-invasive method used to record and assess the electrical activity of the heart. It is performed by placing electrodes on the patient's chest, allowing the measurement and visualization of heart rhythm and cardiac electrical activity over time.
Measured: Immediately before and after the first stimulation session (Day 1); Immediately before and after the last stimulation session (Day 5)
Nociception Coma Scale-revised (NCS-r)
The Nociception Coma Scale-Revised (NCS-R, minimum score: 0; maximum score: 9, with higher scores indicating stronger behavioral responses to nociceptive stimulation) is a standardized clinical assessment tool used to evaluate pain-related responses in patients with disorders of consciousness who are unable to communicate.
Measured: Baseline; Immediately after each of the 5 stimulation sessions (Day 1, 2, 3, 4 and 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas Lejeune, Centre Hospitalier Universitaire de Liege
- Investigators
- Nicolas Lejeune, Principal investigator, University Hospital of Liege - University of LiegeAurore Thibaut, Principal investigator, University of LiegeFanny Montulet, Study director, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874178
- Sponsor's protocol ID
- 2025-346_TI_DoC
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be made available to qualified researchers whose requests are methodologically sound and for legitimate scientific purposes, following publication of the primary study results.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Temporal Interference Stimulation in Patients With Severe Acquired Brain Injury and Disorders of Consciousness
- ClinicalTrials.gov ID
- NCT07874178
- Acronym / sponsor ID
- 2025-346_TI_DoC
- Conditions
- Disorder of Consciousness, Minimally Conscious State, Vegetative State, Unresponsive Wakefulness Syndrome, Brain Injury
- Keywords
- Disorders of consciousness, Traumatic brain injury, Unresponsive wakefulness syndrome, Minimally conscious state, Temporal interference stimulation, Non-invasive brain stimulation, Neurorehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de LiegeUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 14 Oct 2026 (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.
This study aims to investigate whether a new non-invasive brain stimulation technique, called temporal interference stimulation, can influence brain activity and potentially improve signs of consciousness in patients with severe brain injuries and disorders of consciousness.
After a severe brain injury, some patients may remain unable to communicate or interact normally with their environment because of impaired consciousness. Current treatment options to promote recovery are limited. Temporal interference stimulation is a new technique that uses mild electrical currents applied through electrodes placed on the scalp to target specific areas deep inside the brain without surgery.
In this study, we will use brain imaging data to personalize the stimulation and target a region involved in consciousness regulation, called the thalamus. The effects of the stimulation will be evaluated using brain activity recordings, heart monitoring, and clinical assessments of consciousness and responses to stimulation.
The goal of this research is to determine whether temporal interference stimulation is safe and whether it can produce measurable changes in brain function and behavior in patients with disorders of consciousness. The results may help guide future research on new treatments for recovery after severe brain injury.
Detailed description
This open-label pilot study investigates the feasibility and potential neurophysiological and behavioral effects of MRI-guided temporal interference (TI) stimulation targeting the bilateral thalamus in patients with prolonged disorders of consciousness following severe acquired brain injury.
Severe brain injuries can disrupt the neural networks responsible for consciousness, particularly the interactions between the thalamus, basal ganglia, and cortical regions. The mesocircuit model suggests that impaired thalamocortical activation contributes to reduced consciousness after brain injury. While invasive approaches such as deep brain stimulation have shown potential benefits in selected patients, their clinical use is limited by surgical risks and technical constraints. Temporal interference stimulation represents a novel non-invasive neuromodulation approach designed to selectively influence deep brain structures while limiting stimulation of surrounding tissues.
During the study, individualized stimulation parameters will be determined using the patient's structural magnetic resonance imaging data. Computational modeling will be used to optimize electrode placement and electric field distribution in order to target the thalamic region. Stimulation will be delivered through transcranial electrodes placed on the scalp using two high-frequency electrical currents with slightly different frequencies. The interaction between these currents generates a low-frequency modulation at the target region, allowing selective modulation of deep neural structures.
Participants will undergo repeated TI stimulation sessions, with neurophysiological monitoring performed using high-density electroencephalography (127 electrodes) and electrocardiography before and after selected stimulation sessions. Behavioral changes associated with consciousness and responses to stimulation will be assessed using standardized clinical evaluations designed for patients with disorders of consciousness.
The study will also monitor the tolerability and safety of the intervention through continuous observation and systematic recording of potential adverse events. Previous studies of non-invasive brain stimulation techniques have demonstrated favorable safety profiles, with mainly mild and transient effects reported. This investigation aims to provide preliminary evidence regarding the capacity of temporal interference stimulation to modulate brain activity and potentially promote recovery-related changes in patients with severe disorders of consciousness.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Temporal Interference Stimulation | Experimental | Device: Temporal InterferenceTemporal interference stimulation is a non-invasive neuromodulation technique that uses overlapping electrical fields generated by scalp electrodes to selectively influence activity in deep brain regions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years.
- Diagnosis of unresponsive wakefulness syndrome or minimally conscious state confirmed by at least two Coma Recovery Scale-Revised (CRS-R) assessments.
- More than 28 days after the brain injury.
- Acquired brain injury of known etiology, including: Traumatic brain injury; Isolated intracranial hemorrhage (including subarachnoid, subdural, epidural, intracerebral, or iatrogenic hemorrhage); Stroke of any etiology; Cerebral anoxia/hypoxia (e.g., following cardiac arrest, drowning, choking, or drug overdose); Other acquired brain injuries (e.g., infectious encephalitis, carbon monoxide poisoning, or chemical/solvent inhalation).
- Available structural brain MRI.
Key exclusion criteria (4 listed)
- History of neurological or psychiatric disorder prior to the brain injury.
- Pregnancy (excluded based on medical records or a pregnancy test, if applicable).
- Presence of active brain implants and/or intracranial metallic implants.
- Uncontrolled epilepsy
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 |
|---|---|---|
| Temporal InterferenceParticipants in the experimental arm will receive bilateral MRI-guided temporal interference (TI) stimulation targeting the thalami bilaterally. The stimulation will be delivered non-invasively through electrodes placed on the scalp. High-frequency electrical currents with slightly different frequencies will be applied simultaneously to generate a low- frequency modulation at the targeted brain region, allowing selective modulation of thalamic activity. | Device | Temporal Interference Stimulation |
Primary outcome
Coma Recovery Scale - revised (CRS-r)
Time frame: Immediately before and after the first stimulation session (Day 1); immediately after the third stimulation session (Day 3); Immediately before and after the last stimulation session, (Day 5); 1-week follow-up
The Coma Recovery Scale-Revised (CRS-R, minimum score: 0; maximum score: 23, with higher scores indicating a higher level of responsiveness) is a standardized clinical assessment tool used to evaluate levels of consciousness and detect signs of recovery in patients with disorders of consciousness.
7 secondary outcomes
Changes in EEG alpha-band power
Time frame: Immediately before and after the first stimulation session (Day 1); Immediately before and after the last stimulation session (Day 5)
Changes in EEG theta-band power
Time frame: Immediately before and after the first stimulation session (Day 1); Immediately before and after the last stimulation session (Day 5)
Changes in EEG delta-band power
Time frame: Immediately before and after the first stimulation session (Day 1); Immediately before and after the last stimulation session (Day 5)
Changes in EEG spectral profile according to the ABCD model
Time frame: Immediately before and after the first stimulation session (Day 1); Immediately before and after the last stimulation session
Changes in alpha-band functional connectivity
Time frame: Immediately before and after the first stimulation session (Day 1); Immediately before and after the last stimulation session (Day 5)
Heart rate
Time frame: Immediately before and after the first stimulation session (Day 1); Immediately before and after the last stimulation session (Day 5)
Nociception Coma Scale-revised (NCS-r)
Time frame: Baseline; Immediately after each of the 5 stimulation sessions (Day 1, 2, 3, 4 and 5)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be made available to qualified researchers whose requests are methodologically sound and for legitimate scientific purposes, following publication of the primary study results.
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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.
Nicolas Lejeune principal investigator
University Hospital of Liege - University of Liege
Aurore Thibaut principal investigator
University of Liege
Fanny Montulet study director
University of Liege
Questions about this trial
What is this clinical trial studying?
A study testing Temporal Interference in people with Disorder of Consciousness and Minimally Conscious State, run by Centre Hospitalier Universitaire de Liege.
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 7 inclusion and 4 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: opening soon, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas Lejeune (+3243232323, nicolas.lejeune@chuliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coma Recovery Scale - revised (CRS-r) (time frame: Immediately before and after the first stimulation session (Day 1); immediately after the third stimulation session (Day 3); Immediately before and after the last stimulation session, (Day 5); 1-week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2026.