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NCT Number: NCT06822283

Plasticity of Deep Brain Structures in Mild Cognitive Impairment and Healthy Aging

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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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

EPFL Valais, Clinique Romande de readaptation, Sion, Valais, Switzerland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Motor learning performance

    Time frame: 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 outcomes

  1. Brain connectivity

    Time frame: 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 outcomes

  1. Demographic factors form

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Friedhelm Hummel

Other

Collaborators

  • Clinique Romande de Readaptation
  • Fondation Bertarelli
  • Swiss National Science Foundation
  • The Novartis Foundation
  • University of Guadalajara
  • Wyss Center for Bio and Neuroengineering

Registry information

Official study title

Investigation of the Plasticity of Deep Brain Structures in Mild Cognitive Impairment and Healthy Aging (PlasMA)

Acronym: PlasMA

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 12, 2025
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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