An interventional study of Temporal Interference in Disorder of Consciousness, Minimally Conscious State and Vegetative State, sponsored by Centre Hospitalier Universitaire de Liege. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Centre Hospitalier Universitaire de Liege · Not applicable, Interventional, and Treatment
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.
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.
244 studies on the registry are indexed under Consciousness Disorders; 104 are open to participants now.
This study's planned enrollment of 4 is below the median of 44 across 155 interventional studies indexed under Consciousness Disorders.
Browse Consciousness Disorders studies →Centre Hospitalier Universitaire de Liege is the lead sponsor of 39 studies on the registry; 25 are open to participants now.
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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.
Device: Temporal Interference
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.
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.
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
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.
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
Electroencephalographic (EEG) theta-band power will be assessed during resting-state EEG recording. An increase in theta-band power is expected following the intervention.
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
Electroencephalographic (EEG) delta-band power will be assessed during resting-state EEG recording. A decrease in delta-band power is expected following the intervention.
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
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.
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
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
Time frame: 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.
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)
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.
Time frame: Baseline; Immediately after each of the 5 stimulation sessions (Day 1, 2, 3, 4 and 5)
No study locations are listed for this record.
Plan to share: 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.
Supporting information: Study protocol
Time frame: IPD and supporting information will be made available after publication of the primary study results upon reasonable request and subject to approval.
Access criteria: Access to the anonymized individual participant data (IPD) and supporting information, including the study protocol, data dictionary, and statistical analysis code, will be granted to qualified researchers upon reasonable request.Requests will be evaluated by the principal investigator based on scientific validity, methodological quality, and compliance with the original ethical approval and informed consent.Approved users will receive access through a secure institutional repository (e.g., ULiège Dataverse)Only de- identified data will be shared.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Feb 2027, 5 months later.
Of 71 non-industry interventional studies with no phase under Consciousness Disorders, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 52. This study's planned 5 months is below that.
Counting every sponsor, half of 73 studies reached it within 29 months; a quarter within 12 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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