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Closed-Loop Brain Stimulation as a Potential Intervention for Cognitive Decline
NCT05907343 · University of Texas at Austin
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
The goal of this clinical study is to investigate the effectiveness of non-invasive stimulation to enhance cognitive control abilities in older adults with and without cognitive impairment. The main questions it aims to answer are:
* whether it is possible to restore various cognitive functions in older adults 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 closed-loop and open-loop TBS using the outcome metrics described below to see how much cognitive restorations is achievable with each stimulation modality.
Eligibility criteria
Inclusion Criteria:
* 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. Self reports cognitive complaints
* Cognitively normal young adults
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
Exclusion Criteria:
1. Self-report of neurological or psychiatric diseases that could be contraindicated for TMS (e.g., personal history of epilepsy/seizure brain damage, history of fainting, bipolar disorder, schizophrenia, current substance use disorder, etc.).
2. Medications that elevate seizure threshold (e.g., stimulant medication, high dose bupropion).
3. Factors hindering EEG acquisition and rTMS delivery (e.g., skin infection, wounds, dermatitis, unable to access the scalp of the participant (e.g., unremovable wig).
4. Current participation in amyloid infusion treatment for Alzheimer's disease.
5. Do not have the capacity to provide informed consent and does not have a Legally Authorized Representative.
6. Resting motor threshold below the power limit in the laboratory. (Will be check on the first visit)
Study design
Enrollment target: 180 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2023-05-31
Estimated completion: 2027-10-31
Last updated: 2026-09-02
Interventions
Device: Closed-loop TBSDevice: Open-loop TBS
Primary outcomes
- • Cognitive Assessment Batteries (Up to 8 weeks after intervention)
Sponsor
University of Texas at Austin · other
With: Texas Alzheimer's Research and Care Consortium
Contacts & investigators
ContactJosé del R. Millán, PhD · contact · jose.millan@austin.utexas.edu · 512-232-8111
ContactMinsu Zhang · contact · minsuzhang@austin.utexas.edu · 512-840-9310
InvestigatorJosé del R. Millán, PhD · principal_investigator, University of Texas at Austin
InvestigatorJared F. Benge, PhD, ABPP · principal_investigator, University of Texas at Austin
InvestigatorCrystal M. Lantrip, PhD, LP · principal_investigator, Neuropsychological Assessment Clinic
All locations (1)
Health Discovery BuildingRecruiting
Austin, Texas, United States