Using brain stimulation to improve cognitive control in older adults with mild cognitive impairment
Closed-Loop Brain Stimulation as a Potential Intervention for Cognitive Decline
This study is testing if a new type of brain stimulation can help older adults with mild cognitive impairment improve their thinking skills while they play a video game.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University of Texas at Austin Academic / other |
| Locations | 1 site (Austin, Texas) |
| Trial ID | NCT05907343 on ClinicalTrials.gov |
What this trial studies
This clinical study investigates the effectiveness of non-invasive theta burst stimulation (TBS) to enhance cognitive control in older adults diagnosed with mild cognitive impairment (MCI). Participants will engage in a cognitive video game while their brain activity is monitored through a brain-computer interface (BCI) that detects cognitive engagement. The study aims to compare the therapeutic effects of closed-loop TBS, which adapts stimulation based on real-time EEG signals, against open-loop TBS and a sham treatment. The goal is to determine if closed-loop TBS can restore cognitive functions more effectively than traditional methods.
Who should consider this trial
Good fit: Ideal candidates include older adults aged 60 to 90 years with a diagnosis of mild cognitive impairment and cognitively healthy younger adults aged 18 to 35.
Not a fit: Patients with severe cognitive impairment or those outside the specified age ranges may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve cognitive control and memory function in older adults with mild cognitive impairment.
How similar studies have performed: Other studies have shown promise with brain stimulation techniques, but the closed-loop approach in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Cognitively normal younger 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 * Cognitively normal 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. Score of 23 or higher on the Montreal Cognitive Assessment, a brief formal cognitive screening test, which is used to indicate absence of cognitive impairment * Older adults with mild cognitive impairment (MCI) 1. Ages between 60 to 90 years 2. Diagnosis of MCI according to the National Institute on Aging - Alzheimer's Association (NIA-AA) criteria 3. Good general health 4. Normal or corrected vision 5. Completed elementary school education or able to understand middle school level experiment instructions Exclusion Criteria: 1. Neurological or psychiatric diseases (e.g., personal history of epilepsy/seizure brain damage, multiple sclerosis, schizophrenia, substance use disorder, etc.). 2. Current use of psychotropic medications with cognitive side effects (e.g., benzodiazepines, anticonvulsants, antipsychotics, etc.) 3. Current use of cognitive enhancing medications (e.g., Adderall, Memantine, etc.) 4. Factors hindering EEG acquisition and TMS delivery (e.g., skin infection, wounds, dermatitis, etc.) 5. Factors hindering MRI acquisition (e.g., implants, metallic tattoos, etc.)
Where this trial is running
Austin, Texas
- Health Discovery Building — Austin, Texas, United States (Recruiting)
Study contacts
- Principal investigator: José del R. Millán, PhD — University of Texas at Austin
- Study coordinator: José del R. Millán, PhD
- Email: jose.millan@austin.utexas.edu
- Phone: 512-232-8111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.