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

NCT07092839 | Completed

• 1 other identifier: 2020-00127-wp5m
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Mild Cognitive Impairment (MCI)

Keywords

non-invasive brain stimulation; deep brain stimulation; subcortical; memory; neuro-imaging; transcranial temporal interference stimulation; motor learning

Outcome Measures

Primary Outcomes (1)

• Motor learning performance

  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).

  From baseline to 24 hours after training

Secondary Outcomes (1)

• Brain connectivity

  Baseline measure (before the intervention)

Study Arms (2)

Active stimulation

EXPERIMENTAL

Patterned stimulation (intermittent theta-burst) generating temporal interference in the striatum; see Wessel et al., 2023, Nat Neurosci. for details

Other: transcranial electric stimulation

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)

Other: transcranial electric stimulation

Interventions

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.

Active stimulation; Placebo stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Clinical diagnosis of MCI

You may not qualify if:

• 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

Sponsors & Collaborators

• Friedhelm Hummel: lead
• Clinique Romande de Readaptation: collaborator
• HUG University hospital: collaborator
• SNSF: collaborator
• The Novartis Foundation: collaborator
• Wyss Center for Bio and Neuroengineering: collaborator
• Fondation Bertarelli: collaborator

Study Sites (2)

EPFL, Campus Biotech

Geneva, Canton of Geneva, 1202, Switzerland

Location

EPFL Valais, Clinique Romande de readaptation

Sion, Valais, 1951, Switzerland

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 30, 2025
• Study Start: June 1, 2021
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: July 30, 2025

Record last verified: 2025-07

Locations

CH (2)