An interventional study of Closed-loop TBS and Open-loop TBS in Mild Cognitive Impairment and Alzheimer Dementia (AD), sponsored by University of Texas at Austin. Recruiting at 1 site in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by University of Texas at Austin · Not applicable, Interventional, and Treatment
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:
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.
3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.
This study's planned enrollment of 180 is above the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →University of Texas at Austin is the lead sponsor of 328 studies on the registry; 79 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Older adults
Cognitively normal young adults
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Closed-loop TBS
Device: Open-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.
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.
Cognitive Assessment Batteries
NIH Toolbox - Cognition Battery: A computerized battery assessing multiple cognitive domains. The primary metric for all subtests is the age- and education-adjusted T-score (normative mean = 50, standard deviation = 10). Includes: Dimensional Change Card Sort, Face-Name Associative Memory Test, Flanker Inhibitory Control and Attention Test, Picture Sequence Memory Test, Rey Auditory Verbal Learning Test, Pattern Comparison Processing Speed Test
Time frame: Up to 8 weeks after intervention
Accuracy of the BCI classifier output
The BCI classifier output reflects the presence or absence of the cognitive EEG patterns elicited during the cognitive videogame tasks. For each participant, the BCI outputs will be compared to their behavioral responses (pressing or not pressing a button).
Time frame: Up to 8 weeks after intervention
Behavioral performance of the video game task
The behavioral performance, pressing or not pressing a button, reflects the level of cognitive control performance of the subjects. It measures whether the participants made a correct decision, and their response time, in a given trial.
Time frame: Up to 8 weeks after intervention
N-Back Task
Measures working memory capacity and executive function. The primary metrics are accuracy (percentage of correct responses) and reaction time during the n-back conditions.
Time frame: Up to 8 weeks after intervention.
Affective Flexibility Task
Measures the ability to shift cognitive sets in response to emotional versus non-emotional stimuli. The primary metric is the switch cost (the difference in reaction time and accuracy between repeat and switch trials).
Time frame: Up to 8 weeks after intervention
Perseverative Thinking Questionnaire
A 15-item self-report scale measuring transdiagnostic repetitive negative thinking (rumination and worry). Items are rated from 0 (never) to 4 (almost always). The primary metric is the total PTQ score (range 0-60).
Time frame: Up to 8 weeks after intervention
Hamilton Depression Rating Scale
A interview assessing the severity of depressive symptomatology (e.g., mood, insomnia, anxiety). The primary metric is the total score, with higher scores indicating greater severity.
Time frame: Up to 8 weeks after intervention
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — All anonymized data will be made available by the online publication date. These data will be placed in public servers for any interested researcher to access it.
Time frame: Data will become permanently available by the online publication date.
Access criteria: Any interested researcher will have access.
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