Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
Healthy Volunteers
NCT05907343

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

Led by University of Texas at Austin · Updated on 2026-04-29

180

Participants Needed

1

Research Sites

230 weeks

Total Duration

On this page

AI-Summary

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 cognitively healthy adults and older adults diagnosed with mild cognitive disorder (MCI). The main questions it aims to answer are: * whether it is possible to restore various cognitive functions in older adults diagnosed with MCI 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 sham, closed-loop, and open-loop TBS using the outcome metrics described below to see how much cognitive restorations is achievable with each stimulation modality.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 90Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Cognitively normal younger adults aged 18 to 35 years
  • Cognitively normal older adults aged 60 to 90 years
  • Older adults with mild cognitive impairment aged 60 to 90 years
  • Participants must be in good general health
  • Normal or corrected vision
  • Completed elementary school education or able to understand middle school level instructions
  • Cognitively normal older adults must score 23 or higher on the Montreal Cognitive Assessment
  • Older adults with MCI must have a diagnosis according to the National Institute on Aging - Alzheimer's Association criteria
Not Eligible

You will not qualify if you...

  • History of neurological or psychiatric diseases such as epilepsy, brain damage, multiple sclerosis, schizophrenia, or substance use disorder
  • Current use of psychotropic medications with cognitive side effects like benzodiazepines, anticonvulsants, or antipsychotics
  • Current use of cognitive enhancing medications including Adderall or Memantine
  • Conditions that hinder EEG acquisition or TMS delivery such as skin infections, wounds, or dermatitis
  • Conditions that hinder MRI acquisition such as implants or metallic tattoos

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Health Discovery Building

Austin, Texas, United States, 78712

Actively Recruiting

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Research Team

J

José del R. Millán, PhD

CONTACT

M

Minsu Zhang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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