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| Name | Class |
|---|---|
| Clinique Romande de Readaptation | NETWORK |
| University of Guadalajara | OTHER |
| Swiss National Science Foundation | OTHER |
| The Novartis Foundation |
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Acute and chronic cognitive impairment (TBI and MCI) is one of the most common problems in the growing and aging society of the 21st century. At an individual level, not all brain structures are affected with the same rate. There are subcortical structures less involved (e.g., the cerebellum), and other more involved (e.g., the hippocampus) in the cognitive decline with age or following a traumatism. To pave the way for personalized precision medicine in the field of cognitive preservation and recovery, there is a need for testing the impact of individually tailored innovative non-invasive neuro-technologies. In this project, we aim at testing the benefit of non-invasively stimulating subcortical structures to boost resilience in supporting motor and non-motor memory.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo stimulation | Placebo Comparator | Sham stimulation : ramp-up [5 s] immediately followed by ramp-down [5 s] of high-frequency currents (see Vassiliadis et al., 2023, Nat Hum Behav for more details) |
|
| Active stimulation | Experimental | Patterned stimulation (intermittent theta-burst) generating temporal interference in the striatum; see Wessel et al., 2023, Nat Neurosci. for details |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial electric stimulation | Other | 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, we applied tTIS via surface electrodes applying a low-intensity (2mA baseline to peak), sub-threshold protocol following the safety guidelines for low-intensity transcranial electric stimulation in humans. |
| Measure | Description | Time Frame |
|---|---|---|
| Motor learning performance | The primary outcome of the study is the amount of motor learning in a sequential finger-tapping task evaluated during and following training | From baseline to 24 hours after training |
| Measure | Description | Time Frame |
|---|---|---|
| Brain connectivity | Diffusion-weighted and resting-state MRI is performed at baseline and allows to evaluate inter-individual anatomical factors associated to the primary outcome | Baseline measure (before the intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic factors form | These factors including age, sex, handedness, education level and profession, time of diagnosis, physical activity, independency and quality of life, medication, cognitive status will are used to evaluate responsiveness to the intervention | Baseline measure (before the intervention) |
Inclusion Criteria:
TBI patients:
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 (1):
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 Valais, Clinique Romande de readaptation | Sion | Valais | 1951 | Switzerland | ||
| EPFL, Campus Biotech |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37857774 | Background | Wessel MJ, Beanato E, Popa T, Windel F, Vassiliadis P, Menoud P, Beliaeva V, Violante IR, Abderrahmane H, Dzialecka P, Park CH, Maceira-Elvira P, Morishita T, Cassara AM, Steiner M, Grossman N, Neufeld E, Hummel FC. Noninvasive theta-burst stimulation of the human striatum enhances striatal activity and motor skill learning. Nat Neurosci. 2023 Nov;26(11):2005-2016. doi: 10.1038/s41593-023-01457-7. Epub 2023 Oct 19. | |
| 38811696 |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| OTHER |
| Fondation Bertarelli | UNKNOWN |
| Wyss Center for Bio and Neuroengineering | OTHER |
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|
| Geneva |
| 1202 |
| Switzerland |
| Background |
| Vassiliadis P, Beanato E, Popa T, Windel F, Morishita T, Neufeld E, Duque J, Derosiere G, Wessel MJ, Hummel FC. Non-invasive stimulation of the human striatum disrupts reinforcement learning of motor skills. Nat Hum Behav. 2024 Aug;8(8):1581-1598. doi: 10.1038/s41562-024-01901-z. Epub 2024 May 29. |
| 38408385 | Result | Vassiliadis P, Stiennon E, Windel F, Wessel MJ, Beanato E, Hummel FC. Safety, tolerability and blinding efficiency of non-invasive deep transcranial temporal interference stimulation: first experience from more than 250 sessions. J Neural Eng. 2024 Mar 11;21(2). doi: 10.1088/1741-2552/ad2d32. |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |