Closed-Loop Brain Stimulation as a Potential Intervention for Cognitive Decline
NCT ID: NCT05907343
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
180 participants
INTERVENTIONAL
2023-05-31
2026-12-31
Brief Summary
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* whether it is possible to restore various cognitive functions in older adults diagnosed with MCI by delivering theta burst stimulation (TBS), a form of transcranial magnetic stimulation, and
* whether closed-loop TBS is able to induce therapeutic benefits that outperform open-loop TBS.
Participants play a cognitive video game while a brain-computer interface (BCI) analyzes their electroencephalogram (EEG) signals and decodes the presence or absence of the contingent negative variation (CNV) potential, a marker of cognitive control. The BCI triggers TBS when its outputs indicate that the participant is not engaged properly in the video game.
Researchers will compare the effects of sham, closed-loop, and open-loop TBS using the outcome metrics described below to see how much cognitive restorations is achievable with each stimulation modality.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Sham TBS
Sham TBS
A BCI records and analyzes the participant's EEG as they perform cognitively demanding video game tasks. The BCI delivers TBS with a sham coil when its output indicates that the participant is not properly engaged in the video game.
Closed-Loop TBS
Closed-loop TBS
A BCI records and analyzes the participant's EEG as they perform cognitively demanding video game tasks. The BCI delivers TBS with a real coil when its output indicates that the participant is not properly engaged in the video game.
Open-Loop TBS
Open-loop TBS
A BCI records and analyzes the participant's EEG as they perform cognitively demanding video game tasks. TBS with the real coil is delivered irrelevant of the BCI decoder output.
Interventions
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Sham TBS
A BCI records and analyzes the participant's EEG as they perform cognitively demanding video game tasks. The BCI delivers TBS with a sham coil when its output indicates that the participant is not properly engaged in the video game.
Closed-loop TBS
A BCI records and analyzes the participant's EEG as they perform cognitively demanding video game tasks. The BCI delivers TBS with a real coil when its output indicates that the participant is not properly engaged in the video game.
Open-loop TBS
A BCI records and analyzes the participant's EEG as they perform cognitively demanding video game tasks. TBS with the real coil is delivered irrelevant of the BCI decoder output.
Eligibility Criteria
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Inclusion Criteria
1. Ages between 18 to 35 years
2. Good general health
3. Normal or corrected vision
4. Completed elementary school education or able to understand middle school level experiment instructions
* Cognitively normal older adults
1. Ages between 60 to 90 years
2. Good general health
3. Normal or corrected vision
4. Completed elementary school education or able to understand middle school level experiment instructions
5. Score of 23 or higher on the Montreal Cognitive Assessment, a brief formal cognitive screening test, which is used to indicate absence of cognitive impairment
* Older adults with mild cognitive impairment (MCI)
1. Ages between 60 to 90 years
2. Diagnosis of MCI according to the National Institute on Aging - Alzheimer's Association (NIA-AA) criteria
3. Good general health
4. Normal or corrected vision
5. Completed elementary school education or able to understand middle school level experiment instructions
Exclusion Criteria
2. Current use of psychotropic medications with cognitive side effects (e.g., benzodiazepines, anticonvulsants, antipsychotics, etc.)
3. Current use of cognitive enhancing medications (e.g., Adderall, Memantine, etc.)
4. Factors hindering EEG acquisition and TMS delivery (e.g., skin infection, wounds, dermatitis, etc.)
5. Factors hindering MRI acquisition (e.g., implants, metallic tattoos, etc.)
18 Years
90 Years
ALL
Yes
Sponsors
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University of Texas at Austin
OTHER
Responsible Party
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Jose del R. Millan
Professor
Principal Investigators
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José del R. Millán, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Texas at Austin
Robin Hilsabeck, PhD, ABPP
Role: PRINCIPAL_INVESTIGATOR
University of Texas at Austin
Locations
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Health Discovery Building
Austin, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Patrick Escamilla
Role: primary
Other Identifiers
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STUDY00003055
Identifier Type: -
Identifier Source: org_study_id