Recruiting

Brain Stimulation

Sponsor:

University of Texas at Austin

Code:

NCT05907343

Conditions

Mild Cognitive Impairment

Alzheimer Dementia (AD)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Closed-loop TBS

Open-loop TBS

Study Details

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.

Conditions

Mild Cognitive Impairment

Alzheimer Dementia (AD)

Study ID

NCT05907343

Start date

May 31, 2023

Status verified date

Aug, 2026

Completion date

Oct 31, 2027

Anticipated

Primary completion date

Oct 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Closed-Loop TBS

active comparator: Open-Loop TBS

Interventions

Closed-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.

Open-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.

Primary outcome measure

  • Cognitive Assessment Batteries [ Time Frame: Up to 8 weeks after intervention ]

Central Contacts and Locations

Locations

Health Discovery Building

Recruiting

Austin, Texas, United States, 78712

Contacts

More Information

Sponsor

University of Texas at Austin

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Keywords

  • MCI
  • Older adults
  • Cognitive control
  • Memory impairment
  • Memory enhancement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Texas at Austin on 2026-09-02.