NCT07560904

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress55%
Mar 2026Jul 2026

Study Start

First participant enrolled

March 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

April 21, 2026

Last Update Submit

April 28, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • The neural underpinning of NIBS-induced changes quantified by task-fMRI activations

    During intervention ( approximately 10 minutes)

  • The neural underpinning of NIBS-induced changes quantified by network-based analytical approaches.

    During intervention ( approximately 10 minutes)

Secondary Outcomes (2)

  • Working memory performance - Reaction times

    During intervention (approx 10 minutes)

  • Working memory parformance - Accuracy

    During intervention ( approximately 10 minutes)

Study Arms (3)

20 Hz striatal stimulation

EXPERIMENTAL

Striatum will be targeted by using two pairs of high-frequency tES with a low-frequency offset (20 Hz), creating an interference hotspot targeting the deep brain structure (deep-tES).

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

60 Hz striatal stimulation

EXPERIMENTAL

Striatum will be targeted by using two pairs of high-frequency tES with a low-frequency offset (60 Hz), creating an interference hotspot targeting the deep brain structure (deep-tES).

Other: Non-invasive deep brain stimulation of striatum via transcranial temporal interference stimulation (60 Hz)

Sham striatal stimulation

SHAM COMPARATOR

Striatum will be targeted by using two pairs of high-frequency tES with no low-frequency offset. The stimulation will be applied only shortly and turned off after ramp-up and ramp-down period.

Other: Control striatal stimulation

Interventions

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.

Sham striatal stimulation

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).

20 Hz striatal stimulation

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).

60 Hz striatal stimulation

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CEITEC Masaryk University

Brno, 612 00, Czechia

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. Irena Rektorová MD, Ph.D.

Study Record Dates

First Submitted

April 21, 2026

First Posted

May 1, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations