Closed-Loop Brain Stimulation as a Potential Intervention for Cognitive Decline
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity of Texas at Austin
About this trial
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
This trial accepts healthy volunteersQualifiers
Older adults
Ages between 60 to 90 years
Good general health
Normal or corrected vision
Disqualifiers
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.).
Medications that elevate seizure threshold (e.g., stimulant medication, high dose bupropion).
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).
Current participation in amyloid infusion treatment for Alzheimer's disease.
Trial design
Design model
Parallel
Treatments tested in this trial
Closed-loop TBS
DeviceA 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
DeviceA 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.
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: Closed-Loop TBSActive comparator 1 intervention
Group B: Open-Loop TBSActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 interventionSecondary outcomes
1
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 intervention2
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 intervention3
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.4
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 interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Texas at Austin
Lead sponsor
Texas Alzheimer's Research and Care Consortium
Collaborator
Source ClinicalTrials.gov