Closed-Loop Brain Stimulation as a Potential Intervention for Cognitive Decline
Recruiting · NCT05907343 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Texas at Austin
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Older adults
- Ages between 60 to 90 years
- Good general health
- Normal or corrected vision
- Completed elementary school education or able to understand middle school level experiment instructions
- Self reports cognitive complaints
- Cognitively normal young adults
- Ages between 18 to 35 years
- Good general health
- Normal or corrected vision
- Completed elementary school education or able to understand middle school level experiment instructions
Exclusion criteria
- 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.
- Do not have the capacity to provide informed consent and does not have a Legally Authorized Representative.
- Resting motor threshold below the power limit in the laboratory. (Will be check on the first visit)
Where it is running
1 location listed across 1 US state.
- Health Discovery Building - Austin, Texas, United States