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NCT Number: NCT07560904

Non-invasive Stimulation of Deep Brain Structures to Modulate Working Memory

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.

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Key information

Conditions

Older Adults (60 - 85 Years Old) Cognition Disorders Cognitive Dysfunction Mental Disorders Mild Cognitive Impairment (MCI) Neurocognitive Disorders

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • Psychiatric disorders including major depression, major vascular lesions, or other brain pathologies that might present with cognitive decline.

Treatment and study plan

Non-invasive deep brain stimulation of striatum via transcranial temporal interference stimulation (20 Hz)

Other

Striatum 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

A 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

Striatum 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).

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

    Time frame: During intervention (approx 10 minutes)

    Reaction times of an N-back task between the real and sham stimulation condition in a cross-over design.

  2. Working memory parformance - Accuracy

    Time frame: During intervention ( approximately 10 minutes)

    Accuracy (measured as D-prime) of an N-back task between the real and sham stimulation condition in a cross-over design.

Study contacts

Contact information is provided by the study sponsor or research team.

Monika Pupíková

CONTACT

[email protected]

+420549498818

Sponsors and collaborators

Lead sponsor

Masaryk University

Other

Registry information

Acronym: DEEPBRAIN

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 1, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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