Mild Cognitive Impairment (MCI)
Conditions
Keywords
non-invasive brain stimulation, deep brain stimulation, subcortical, memory, neuro-imaging, transcranial temporal interference stimulation, motor learning
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.
Detailed description
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.
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
SNSF
The Novartis Foundation
Wyss Center for Bio and Neuroengineering
Fondation Bertarelli
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motor learning performance | 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
| Measure | Time frame | Description |
|---|---|---|
| Brain connectivity | 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). |
Countries
Switzerland
Outcome results
None listed