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NCT05907343Recruiting

Closed-Loop Brain Stimulation as a Potential Intervention for Cognitive Decline

Source: ClinicalTrials.gov · Last updated 2 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
180 (estimated)
First submitted
7 Jun 2023
Start date
31 May 2023
Primary completion date
31 Oct 2027
Lead sponsor
University of Texas at Austin
NCT number
NCT05907343

What you commit to

  • Study type: Interventional
  • Planned participants: 180
  • From 31 May 2023 to the primary completion date, 31 Oct 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.

Lab values

  • Resting motor threshold below the power limit in the laboratory. (Will be check on the first visit)

Other

  • Do not have the capacity to provide informed consent and does not have a Legally Authorized Representative.

Who the study is looking for

  • 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

Age in the registry: 18 years to 90 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Health Discovery Building
Coordinator of this site? Confirm its status
AustinUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.