Non-invasive Stimulation of Deep Brain Structures to Modulate Working Memory
DEEPBRAIN
1 other identifier
interventional
70
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2026
Shorter than P25 for not_applicable
1 active site
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 Start
First participant enrolled
March 1, 2026
CompletedFirst Submitted
Initial submission to the registry
April 21, 2026
CompletedFirst Posted
Study publicly available on registry
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
May 1, 2026
April 1, 2026
4 months
April 21, 2026
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
EXPERIMENTALStriatum 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).
60 Hz striatal stimulation
EXPERIMENTALStriatum 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).
Sham striatal stimulation
SHAM COMPARATORStriatum 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.
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.
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).
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).
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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