Non-invasive Stimulation of Deep Brain Structures to Modulate Working Memory
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-80
SponsorMasaryk University
About this trial
A study investigating the effects of non-invasive electrical stimulation of deep brain structures on working memory, attention, and executive functions involved in everyday activities. Currently, there is no effective treatment for impairments in these functions. The study will evaluate the effects of non-invasive electrical stimulation in both healthy older adults and individuals with mild impairment of these functions.
The study combines magnetic resonance imaging (MRI) with non-invasive brain stimulation targeting deep brain structures. Its aim is to improve understanding of the neural mechanisms underlying these cognitive functions and their impairments, as well as to explore the mechanisms of non-invasive brain stimulation for potential future therapeutic applications.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
normal cognitive performance as assessed by a cognitive screening for healthy subjects
possible or probable MCI-LB or with PD-MCI, collectively called MCI-LBD, described as: presence of PD , and level II criteria for MCI (i.e. based on comprehensive neuropsychological examination), or the level II criteria for MCI , and at least two of four core DLB features including parkinsonism, visual hallucinations, attention/cognitive function fluctuation, and REM sleep behavioral disorder, or at least 1 core clinical feature and 1 indicative biomarker (probable MCI-LB).
Disqualifiers
Psychiatric disorders including major depression, major vascular lesions, or other brain pathologies that might present with cognitive decline.
Trial design
Design model
Crossover
Treatments tested in this trial
Non-invasive deep brain stimulation of striatum via transcranial temporal interference stimulation (20 Hz)
Other interventionStriatum will be targeted by using at least two pairs of high-frequency tES with a low-frequency (20 Hz) offset, creating an interference hotspot targeting the deep brain structure (deep-tES).
Control striatal stimulation
Other interventionA high-frequency tES without low-frequency offset. It will consist of two oscillatory high-frequency currents without any frequency shifts, which induces similar skin sensations as deep-tES and will be applied just for a ramp-up/ramp-down phases at the beginning of the stimulation and afterwards will be switched off.
Non-invasive deep brain stimulation of striatum via transcranial temporal interference stimulation (60 Hz)
Other interventionStriatum will be targeted by using at least two pairs of high-frequency tES with a low-frequency (60 Hz) offset, creating an interference hotspot targeting the deep brain structure (deep-tES).
Treatment groups
70 Participants
are divided into 3 treatment groupsGroup A: 20 Hz striatal stimulationExperimental treatment 1 intervention
Group B: 60 Hz striatal stimulationExperimental treatment 1 intervention
Group C: Sham striatal stimulationSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
The neural underpinning of NIBS-induced changes quantified by task-fMRI activations
Time frame
During intervention ( approximately 10 minutes)2
The neural underpinning of NIBS-induced changes quantified by network-based analytical approaches.
Time frame
During intervention ( approximately 10 minutes)Secondary outcomes
1
Working memory performance - Reaction times
Reaction times of an N-back task between the real and sham stimulation condition in a cross-over design.
Time frame
During intervention (approx 10 minutes)2
Working memory parformance - Accuracy
Accuracy (measured as D-prime) of an N-back task between the real and sham stimulation condition in a cross-over design.
Time frame
During intervention ( approximately 10 minutes)Sponsors and contacts
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Source ClinicalTrials.gov