Older Adults (60 - 85 Years Old)DEEPBRAINNCT07560904
Non-invasive Stimulation of Deep Brain Structures to Modulate Working Memory
A study testing Non-invasive deep brain stimulation of striatum via transcranial temporal interference stimulation (20 Hz) and Non-invasive deep brain stimulation of striatum via transcranial temporal interference stimulation (60 Hz) in people with Older Adults (60 - 85 Years Old) and Mild Cognitive Impairment (MCI), run by Masaryk University at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Older Adults (60 - 85 Years Old), Mild Cognitive Impairment (MCI)
- What is being tested?
- Non-invasive deep brain stimulation of striatum via transcranial temporal interference stimulation (20 Hz) and Non-invasive deep brain stimulation of striatum via transcranial temporal interference stimulation (60 Hz)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Mar 2026to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Psychiatric disorders including major depression, major vascular lesions, or other brain pathologies that might present with cognitive decline.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
CEITEC Masaryk University
Brno, 612 00
Monika Pupíková, +420549498818, monika.pupikova@ceitec.muni.cz
pupikovam@gmail.com
About this study
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.
- Being tested
- Non-invasive deep brain stimulation of striatum via transcranial temporal interference stimulation (20 Hz), Control striatal stimulation, Non-invasive deep brain stimulation of striatum via transcranial temporal interference stimulation (60 Hz)
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 stimulationOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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. Receives: Other: Control striatal stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The neural underpinning of NIBS-induced changes quantified by task-fMRI activations
Measured: During intervention ( approximately 10 minutes)
The neural underpinning of NIBS-induced changes quantified by network-based analytical approaches.
Measured: During intervention ( approximately 10 minutes)
Secondary outcomes (2)
Working memory performance - Reaction times
Reaction times of an N-back task between the real and sham stimulation condition in a cross-over design.
Measured: During intervention (approx 10 minutes)
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.
Measured: During intervention ( approximately 10 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 Mar 2026
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older Adults (60 - 85 Years Old)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masaryk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monika Pupikova, Masaryk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07560904
- Sponsor's protocol ID
- NW25-04-00142
- Acronym
- DEEPBRAIN
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Stimulation of Deep Brain Structures to Modulate Working Memory
- ClinicalTrials.gov ID
- NCT07560904
- Acronym / sponsor ID
- DEEPBRAIN / NW25-04-00142
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Masaryk UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 20 Hz striatal stimulation | Experimental | Other: Non-invasive deep brain stimulation of striatum via transcranial temporal interference stimulation (20 Hz)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). |
| 60 Hz striatal stimulation | Experimental | Other: Non-invasive deep brain stimulation of striatum via transcranial temporal interference stimulation (60 Hz)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). |
| Sham striatal stimulation | Sham comparator | Other: Control striatal stimulationStriatum 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. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- Psychiatric disorders including major depression, major vascular lesions, or other brain pathologies that might present with cognitive decline.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Other | 20 Hz striatal stimulation |
| Control striatal stimulationA 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. | Other | Sham striatal stimulation |
| 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). | Other | 60 Hz striatal stimulation |
Primary outcome
The neural underpinning of NIBS-induced changes quantified by task-fMRI activations
Time frame: 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)
2 secondary outcomes
Working memory performance - Reaction times
Time frame: During intervention (approx 10 minutes)
Working memory parformance - Accuracy
Time frame: During intervention ( approximately 10 minutes)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive deep brain stimulation of striatum via transcranial temporal interference stimulation (20 Hz) and Non-invasive deep brain stimulation of striatum via transcranial temporal interference stimulation (60 Hz) in people with Older Adults (60 - 85 Years Old) and Mild Cognitive Impairment (MCI), run by Masaryk University at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monika Pupíková (+420549498818, monika.pupikova@ceitec.muni.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The neural underpinning of NIBS-induced changes quantified by task-fMRI activations (time frame: During intervention ( approximately 10 minutes)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.