Clinical Trials

Closed-loop brain stimulation as a potential intervention for cognitive decline

Study status: Recruiting

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.

Participation criteria
Conditions & interventions
More information
  • Sex: All
  • Minimum age: 18 Years
  • Maximum age: 90 Years
  • Healthy volunteers: Yes

Researchers look for people who fit a certain description, called eligibility criteria. Below are the inclusion and exclusion criteria for study participants:

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)

Conditions

Mild cognitive impairment, Alzheimer dementia (AD)

Intervention/treatment

Intervention/treatment

  • Device: Closed-loop TBS
  • Device: Open-loop TBS

Sponsor

University of Texas at Austin

Principal investigator(s)

  • José del R. Millán, PhD, Principal investigator, University of Texas at Austin
  • Jared F. Benge, PhD, ABPP, Principal investigator, University of Texas at Austin
  • Crystal M. Lantrip, PhD, LP, Principal investigator, Neuropsychological Assessment Clinic

Phase

  • Not applicable