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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-00127 | Other Identifier | Commission cantonale d'Éthique de la Recherche sur l'être humain Vaud (CER-VD) |
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| Name | Class |
|---|---|
| Fondation Bertarelli | UNKNOWN |
| The Novartis Foundation | OTHER |
| Clinique Romande de Readaptation | NETWORK |
| University of Guadalajara |
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Impairments in spatial memory and spatial navigation are commonly reported amongst patients presenting post-traumatic brain injury (TBI). In this study, the investigators examine the effect of non-invasive deep brain stimulation of the hippocampal-entorhinal complex (HC-EC), a key region supporting navigation abilities, on spatial navigation performance in TBI patients. Using a virtual reality task where participants must first encode and later recall the location of objects in a virtual arena, the investigators contrast performance while active versus control stimulation is applied to the HC-EC. The investigators additionally record brain activity using electroencephalography (EEG) prior to, during, and after task performance to characterize the neural correlates of spatial navigation abilities in TBI patients, and how they are affected by stimulation.
Patients will perform a virtual reality spatial navigation task comparable to that used previously by Beanato and colleagues (2024; DOI: 10.1126/sciadv.ado4103). Patients will perform 4 blocks of task, each lasting approximately 10 minutes; during the full duration of each block, either active or control transcranial temporal interference stimulation (tTIS) will be applied in an interleaved manner, and EEG recordings will be collected. Resting-state EEG recordings will also be collected prior to and following task performance.
Structural, diffusion-weighted, and resting-state MRI scans will additionally be performed during a prior baseline session.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active stimulation | Experimental | Patterned stimulation (intermittent theta-burst) generating temporal interference in the hippocampal-entorhinal complex; see Beanato et al. 2024, Sci Adv (DOI: 10.1126/sciadv.ado4103) for details. |
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| Control stimulation | Placebo Comparator | High-frequency (2kHz) electrical stimulation with no frequency shift, generating no temporal interference. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial electric stimulation | Other | Transcranial temporal interference stimulation (tTIS) is an innovative non-invasive brain stimulation approach, in which two or more independent stimulation channels deliver high-frequency currents in the kHz range (oscillating at f1 and f1 + Δf). These high-frequency currents are assumed to be too high to effectively modulate neuronal activity. Still, by applying a small shift in frequency, they result in a modulated electric field with the envelope oscillating at the low-frequency Δf (target frequency) where the two currents overlap. The peak of the modulated envelope amplitude can be steered towards specific areas located deep in the brain, by tuning the positions of the electrodes and the current ratio across stimulation channels. Here, the investigators apply tTIS via surface electrodes applying a low-intensity, sub-threshold protocol following the safety guidelines for low-intensity transcranial electric stimulation in humans. |
| Measure | Description | Time Frame |
|---|---|---|
| Speed in the spatial navigation task | Participant speed (in seconds) of departure to, and reach of, object location in the virtual reality spatial navigation task. | During intervention (approximate duration of intervention = 40 minutes, administered in a single session) |
| Accuracy in the spatial navigation task | Accuracy (error, in virtual meters, between correct and recalled object location) in the virtual reality spatial navigation task. | During intervention (approximate duration of intervention = 40 minutes, administered in a single session) |
| Measure | Description | Time Frame |
|---|---|---|
| Brain oscillatory activity | Resting-state and task-related EEG recordings are collected, and metrics of oscillatory activity are extracted to characterize the neural activity associated to the primary outcome. | Peri-interventional (up to 1 hour; approximate duration of intervention = 40 minutes, administered in a single session) |
| Measure | Description | Time Frame |
|---|---|---|
| Age (years) | Participant age will be recorded to examine its influence on individual responsiveness to the intervention. | Baseline (before the intervention) |
| Montreal Cognitive Assessment questionnaire score |
Inclusion Criteria:
Exclusion Criteria:
Unable to consent
Severe neuropsychiatric (e.g., major depression, severe dementia) or unstable systemic diseases (e.g., severe progressive and unstable cancer, life threatening infectious diseases)
Severe sensory or cognitive impairment or musculoskeletal dysfunctions prohibiting to understand instructions or to perform the experimental tasks
Inability to follow or non-compliance with the procedures of the study
Contraindications for NIBS or MRI:
Regular use of narcotic drugs
Pregnancy
Request of not being informed in case of incidental findings
Concomitant participation in another trial involving probing of neuronal plasticity
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EPFL, Campus Biotech | Geneva | Canton of Geneva | 1202 | Switzerland |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D065854 | Spatial Navigation |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| OTHER |
| Swiss National Science Foundation | OTHER |
| Wyss Center for Bio and Neuroengineering | OTHER |
| Fondation Akiva | UNKNOWN |
| Canton du Valais | UNKNOWN |
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| Brain structure and connectivity |
Structural, diffusion-weighted, and resting-state MRI scans are performed during the baseline session and are used to evaluate inter-individual anatomical factors associated to the primary outcome. |
| Baseline (before the intervention) |
Participant score on the Montreal Cognitive Assessment questionnaire will be collected to examine its influence on individual responsiveness to the intervention.
| Baseline (before the intervention) |
| Frontal Assessment Battery questionnaire score | Participant score in the Frontal Assessment Battery questionnaire will be collected to examine its influence on individual responsiveness to the intervention. | Baseline (before the intervention) |
| EPFL Valais, Clinique Romande de readaptation | Sion | Valais | 1950 | Switzerland |
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| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D013037 | Spatial Behavior |
| D001519 | Behavior |