Clinical trial NCT06680154: Induction and Stabilization of Gamma Oscillations With 40 Hz External Brain Stimulation
Official title: Gamma Oscillations and Working Memory Following Combined 40Hz tACS and iTBS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Working Memory
EEG Brain Oscillations
Keywords: Alzheimer's disease
Gamma oscillations
EEG
Transcranial alternating current stimulation, tACS
Intermittent theta burst stimulation
Lead sponsor: The National Brain Mapping Laboratory (NBML)
Sponsor class: OTHER
Collaborators: name: Leibniz Research Centre for Working Environment and Human Factors
First posted: 2024-11-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of the present studies is to develop and validate novel stimulation protocols for the entrainment of gamma oscillations, which are associated with many cognitive functions and critically involved in cognitive impairment such as Alzheimer's disease. In this proposal, combination of repetitive transcranial magnetic stimulation (rTMS) and transcranial alternating current stimulation (tACS), which has been shown effective for the induction, and stabilisation of alpha and theta frequencies in our forgoing studies, will be adopted to the gamma frequency range and applied on prefrontal regions as well as model-based cortical areas to enhance and stabilize gamma oscillations, thereby facilitating cognition

Detailed description: Neuropsychiatric disorders are a leading cause of global disability-adjusted life years, and treatment solutions are lacking. Recent findings suggest that non-invasive brain stimulation may be a valuable option in conditions such as epilepsy or Alzheimer's disease (AD). Still, a better understanding of mechanisms and patient-specific factors is needed. Personalized hybrid brain models uniting the physics of electromagnetism with physiology - NeuroTwins (NeTs) - are poised to play a fundamental role in understanding and optimizing the effects of stimulation at the individual level. The purpose of this project is to deliver solutions through model-driven, individualized therapy. A computational framework - weaved and validated across scales and levels of detail - will be proposed to represent the mechanisms of interaction of electric fields with brain networks and assimilate neuroimaging data. This will allow us to characterize the dynamical landscape of the individual brain and define strategies to restore healthy dynamics. The work package, which will take place at IfADo, is part of the consortium collaborating with labs across Europe and USA, aiming to validate and optimize the realistic hybrid brain models developed by NeTs. The targeted subject groups of the IfADo project will be healthy young and old participants. Non-invasive brain stimulation including repetitive transcranial magnetic stimulation and transcranial alternating current stimulation will be applied with electroencephalography, and magnetic resonance spectroscopy as outcome measures. The results are to be translated into a technology pipeline for the design of new personalized neuromodulation protocols which will further be tested in a cohort of AD patients by another clinical consortium member, delivering model-driven breakthroughs in basic and clinical neuroscience, with patients ultimately benefiting from safe, individualized therapy solutions.

Eligibility criteria: Inclusion Criteria:

* normal or corrected to normal eye vision
* right-handed
* non-smokers
* being 18-60 years old
* providing written informed consent

Exclusion Criteria:

* history of neurological or psychiatric disorders including seizures or epilepsy,
* Taking CNS medication
* having metal implants
* current pregnancy

Primary outcomes:
measure: Working Memory behavioral performance
timeFrame: During procedure (20 minutes)
measure: electroencephalogram (EEG) oscillatory power
timeFrame: up to 2 hours after the intervention
measure: electroencephalogram (EEG) functional connectivity
timeFrame: up to 2 hours after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Dortmund
country: Germany
facility: Leibniz-Institut für Arbeitsforschung
state: NRW
Study officials:
References: