Alzheimer Dementia (AD), Mild Cognitive Impairment
Conditions
Keywords
MCI, Older adults, Cognitive control, Memory impairment, Memory enhancement
Brief summary
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.
Interventions
DEVICEClosed-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.
DEVICEOpen-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.
Sponsors
University of Texas at Austin
Texas Alzheimer's Research and Care Consortium
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Assessment Batteries | Up to 8 weeks after intervention | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perseverative Thinking Questionnaire | Up to 8 weeks after intervention | 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). |
| Hamilton Depression Rating Scale | Up to 8 weeks after intervention | 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. |
| Affective Flexibility Task | Up to 8 weeks after intervention | 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). |
| Accuracy of the BCI classifier output | Up to 8 weeks after intervention | 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). |
| Behavioral performance of the video game task | Up to 8 weeks after intervention | 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. |
| N-Back Task | Up to 8 weeks after intervention. | Measures working memory capacity and executive function. The primary metrics are accuracy (percentage of correct responses) and reaction time during the n-back conditions. |
Countries
United States
Contacts
CONTACTJosé del R. Millán, PhD
CONTACTMinsu Zhang
PRINCIPAL_INVESTIGATORJosé del R. Millán, PhD
University of Texas at Austin
PRINCIPAL_INVESTIGATORJared F. Benge, PhD, ABPP
University of Texas at Austin
PRINCIPAL_INVESTIGATORCrystal M. Lantrip, PhD, LP
Neuropsychological Assessment Clinic
Outcome results
None listed