Traumatic Brain Injury
Conditions
Keywords
non-invasive brain stimulation, deep brain stimulation, subcortical, memory, neuro-imaging, transcranial temporal interference stimulation, motor learning
Brief summary
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.
Interventions
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.
Sponsors
Clinique Romande de Readaptation
HUG University hospital
SNF Swiss National Foundation
The Novartis Foundation
Fondation Bertarelli
Wyss Center for Bio and Neuroengineering
Friedhelm Hummel
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
TBI patients: * Age ≥ 18 years * Clinical diagnosis of TBI * No history of other severe neurological or psychiatric disorders
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): * Electronic or ferromagnetic medical implants/device, non-MRI compatible metal implant * History of seizures * Medication that significantly interacts with NIBS being benzodiazepines, tricyclic antidepressants and antipsychotics * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motor learning performance | From baseline to 24 hours after training | The primary outcome of the study is the amount of motor learning in a sequential finger-tapping task evaluated during and following training |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brain connectivity | Baseline measure (before the intervention) | Diffusion-weighted and resting-state MRI is performed at baseline and allows to evaluate inter-individual anatomical factors associated to the primary outcome |
Other
| Measure | Time frame | Description |
|---|---|---|
| Demographic factors form | Baseline measure (before the intervention) | 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 |
Countries
Switzerland
Outcome results
None listed