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

Friedhelm Hummel

Status: Completed

Conditions: Mild Cognitive Impairment (MCI)

Treatments: Other: transcranial electric stimulation

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT07092839

2020-00127-wp5m

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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15 participants in 2 patient groups, including a placebo group

Active stimulation

Experimental group

Description:

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

Treatment:

Other: transcranial electric stimulation

Placebo stimulation

Placebo Comparator group

Description:

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)

Treatment:

Other: transcranial electric stimulation