Clinical trial NCT06822283: Plasticity of Deep Brain Structures in Mild Cognitive Impairment and Healthy Aging
Official title: Investigation of the Plasticity of Deep Brain Structures in Mild Cognitive Impairment and Healthy Aging (PlasMA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: non-invasive brain stimulation
deep brain stimulation
subcortical
memory
neuro-imaging
transcranial temporal interference stimulation
motor learning
Lead sponsor: Ecole Polytechnique Fédérale de Lausanne
Sponsor class: OTHER
Collaborators: name: Clinique Romande de Readaptation
name: HUG University hospital
name: SNF Swiss National Foundation
name: The Novartis Foundation
name: Fondation Bertarelli
name: Wyss Center for Bio and Neuroengineering
First posted: 2025-02-12
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Motor learning performance
timeFrame: From baseline to 24 hours after training
Secondary outcomes:
measure: Brain connectivity
timeFrame: Baseline measure (before the intervention)
Other outcomes:
measure: Demographic factors form
timeFrame: Baseline measure (before the intervention)
Locations:
city: Sion
country: Switzerland
facility: EPFL Valais, Clinique Romande de readaptation
state: Valais
city: Geneva
country: Switzerland
facility: EPFL, Campus Biotech
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.