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NCT Number: NCT05907343

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

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.

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Key information

Conditions

Mild Cognitive Impairment Alzheimer Dementia (AD) Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Memory Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Tauopathies

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Discovery Building

Austin, Texas, 78712, United States

Location status: Recruiting

Location contact

Patrick Escamilla

CONTACT

[email protected]

512-495-5246

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.
  • Do not have the capacity to provide informed consent and does not have a Legally Authorized Representative.
  • Resting motor threshold below the power limit in the laboratory. (Will be check on the first visit)

Treatment and study plan

Closed-loop TBS

Device

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

Device

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 outcomes

  1. Cognitive Assessment Batteries

    Time frame: Up to 8 weeks after intervention

    NIH Toolbox - Cognition Battery: A computerized battery assessing multiple cognitive domains. The primary metric for all subtests is the age- and education-adjusted T-score (normative mean = 50, standard deviation = 10).

    Includes: Dimensional Change Card Sort, Face-Name Associative Memory Test, Flanker Inhibitory Control and Attention Test, Picture Sequence Memory Test, Rey Auditory Verbal Learning Test, Pattern Comparison Processing Speed Test

Secondary outcomes

  1. Accuracy of the BCI classifier output

    Time frame: Up to 8 weeks after intervention

    The BCI classifier output reflects the presence or absence of the cognitive EEG patterns elicited during the cognitive videogame tasks. For each participant, the BCI outputs will be compared to their behavioral responses (pressing or not pressing a button).

  2. Behavioral performance of the video game task

    Time frame: Up to 8 weeks after intervention

    The behavioral performance, pressing or not pressing a button, reflects the level of cognitive control performance of the subjects. It measures whether the participants made a correct decision, and their response time, in a given trial.

  3. N-Back Task

    Time frame: Up to 8 weeks after intervention.

    Measures working memory capacity and executive function. The primary metrics are accuracy (percentage of correct responses) and reaction time during the n-back conditions.

  4. Affective Flexibility Task

    Time frame: Up to 8 weeks after intervention

    Measures the ability to shift cognitive sets in response to emotional versus non-emotional stimuli. The primary metric is the switch cost (the difference in reaction time and accuracy between repeat and switch trials).

  5. Perseverative Thinking Questionnaire

    Time frame: Up to 8 weeks after intervention

    A 15-item self-report scale measuring transdiagnostic repetitive negative thinking (rumination and worry). Items are rated from 0 (never) to 4 (almost always). The primary metric is the total PTQ score (range 0-60).

  6. Hamilton Depression Rating Scale

    Time frame: Up to 8 weeks after intervention

    A interview assessing the severity of depressive symptomatology (e.g., mood, insomnia, anxiety). The primary metric is the total score, with higher scores indicating greater severity.

Study contacts

Contact information is provided by the study sponsor or research team.

José del R. Millán, PhD

CONTACT

[email protected]

512-232-8111

Minsu Zhang

CONTACT

[email protected]

512-840-9310

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Collaborators

  • Texas Alzheimer's Research and Care Consortium

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 18, 2023
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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