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Completed

NCT Number: NCT07092839

Non-invasive Deep Brain Stimulation to Enhance Motor Skill Acquisition in Individuals With Mild Cognitive Impairment

The goal of this study is to investigate the impact of non-invasive deep brain stimulation on motor skill acquisition in individuals with Mild Cognitive Impairment. Participants performed a motor task with non-invasive deep brain stimulation applied to the striatum, which is crucial for motor skill acquisition. The study compared motor skill performance between with the active stimulation and the control stimulation.

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Key information

Conditions

Mild Cognitive Impairment (MCI) Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

EPFL, Campus Biotech, Geneva, Canton of Geneva, Switzerland

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About this study

This study implemented a randomized, double-blinded, and sham-controlled design, investigating the effects of non-invasive deep brain stimulation on motor skill acquisition in individuals Mild Cognitive Impairment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years
  • Clinical diagnosis of MCI

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 a laboratory-developed computerized motor task. It is not a standardized clinical scale, but a custom-designed measure specifically created to assess motor learning (e.g., Maceira-Elvira et al. 2022). The task consists of pressing, as quickly and accurately as possible, four buttons corresponding to the fingers labeled from 2 to 5 (2 for the index and 5 for the pinky finger). According to an explicit sequence displayed on a computer screen, the participants learn the sequence. The task performance is evaluated as how fast (sequence, consisting 9 elements/button key presses) and accurate (% of correct sequence) participants perform, within a block of 90 seconds, and their changes over time (during training and following training).

Secondary outcomes

  1. Brain connectivity

    Time frame: Baseline measure (before the intervention)

    Diffusion-weighted and resting-state MRI are performed at baseline, and they allow to evaluate inter-individual anatomical factors associated to the primary outcome. While specific hypotheses exist, particularly regarding cortico-subcortical interactions (i.e., involving striatum), the analyses are exploratory in nature, given complexity of connectivity measures. Functional connectivity will be evaluated using correlation-based methods and graph metrics; structural connectivity will be assessed through diffusion tractography (with graph metrics as well).

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)

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 30, 2025
Registry last updated
Jul 30, 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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