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

April 28, 2026 updated by: Monika Pupikova, Masaryk University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 20 Hz striatal stimulation
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)
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).
Experimental: 60 Hz striatal stimulation
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)
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).
Sham Comparator: Sham striatal stimulation
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The neural underpinning of NIBS-induced changes quantified by task-fMRI activations
Time Frame: During intervention ( approximately 10 minutes)
During intervention ( approximately 10 minutes)
The neural underpinning of NIBS-induced changes quantified by network-based analytical approaches.
Time Frame: During intervention ( approximately 10 minutes)
During intervention ( approximately 10 minutes)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During intervention (approx 10 minutes)
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.
During intervention ( approximately 10 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masaryk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

April 21, 2026

First Submitted That Met QC Criteria

April 28, 2026

First Posted (Actual)

May 1, 2026

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NW25-04-00142

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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