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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 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.

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Memory Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

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

  • Cognitively normal younger 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
  • Cognitively normal 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
  • Score of 23 or higher on the Montreal Cognitive Assessment, a brief formal cognitive screening test, which is used to indicate absence of cognitive impairment
  • Older adults with mild cognitive impairment (MCI)
  • Ages between 60 to 90 years
  • Diagnosis of MCI according to the National Institute on Aging - Alzheimer's Association (NIA-AA) criteria
  • Good general health
  • Normal or corrected vision
  • Completed elementary school education or able to understand middle school level experiment instructions

Exclusion criteria

  • Neurological or psychiatric diseases (e.g., personal history of epilepsy/seizure brain damage, multiple sclerosis, schizophrenia, substance use disorder, etc.).
  • Current use of psychotropic medications with cognitive side effects (e.g., benzodiazepines, anticonvulsants, antipsychotics, etc.)
  • Current use of cognitive enhancing medications (e.g., Adderall, Memantine, etc.)
  • Factors hindering EEG acquisition and TMS delivery (e.g., skin infection, wounds, dermatitis, etc.)
  • Factors hindering MRI acquisition (e.g., implants, metallic tattoos, etc.)

Treatment and study plan

Sham 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 sham coil when its output indicates that the participant is not properly engaged in the video game.

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. Behavioral performance of the video game task

    Time frame: Up to 1 hour 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.

  2. Accuracy of the BCI classifier output

    Time frame: Up to 1 hour 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).

  3. Cognitive assessment I: Montreal Cognitive Assessment

    Time frame: Up to 8 weeks after intervention

    Telephone version, Score range: 0 - 22* (Units on a Scale)

    (* high scores = better)

  4. Cognitive assessment II: Hopkins Adult Reading Test

    Time frame: Up to 8 weeks after intervention

    Score range: 70 - 131* (Units on a Scale)

    (* high scores = better)

  5. Cognitive assessment III: Multilingual Naming Test

    Time frame: Up to 8 weeks after intervention

    Score range: 0 - 32* (Units on a Scale)

    (* high scores = better)

  6. Cognitive assessment IV: Animal Naming

    Time frame: Up to 8 weeks after intervention

    Score range: 0 - 40* (Units on a Scale)

    (* high scores = better)

  7. Cognitive assessment V: Number Span

    Time frame: Up to 8 weeks after intervention

    • Forward, Score range: 0 - 14* (Units on a Scale)
    • Backward, Score range: 0 - 14* (Units on a Scale)

    (* high scores = better)

  8. Cognitive assessment VI: Trail Making Test

    Time frame: Up to 8 weeks after intervention

    Parts A and B, Score range: 10 - 300** (Units on a Scale)

    (** high scores = worse)

  9. Cognitive assessment VII: Southwestern Assessment of Processing Speed

    Time frame: Up to 8 weeks after intervention

    Score range: 0 - 75* (Units on a Scale)

    (* high scores = better)

  10. Cognitive assessment VIII: Hopkins Verbal Learning Test-Revised

    Time frame: Up to 8 weeks after intervention

    • Immediate Total, Score range: 0 - 36* (Units on a Scale)
    • Delayed Recall, Score range:0 - 12* (Units on a Scale)
    • Percent Retention, Score range:0 - 100* (Units on a Scale)

    (* high scores = better)

  11. Cognitive assessment IX: Brief Visuospatial Memory Test-Revised

    Time frame: Up to 8 weeks after intervention

    • Immediate Total, Score range: 0 - 36* (Units on a Scale)
    • Delayed Recall, Score range:0 - 12* (Units on a Scale)
    • Percent Retention, Score range:0 - 100* (Units on a Scale)

    (* high scores = better)

  12. Cognitive assessment X: Controlled Oral Word Association Test

    Time frame: Up to 8 weeks after intervention

    Score range: 0 - 80* (Units on a Scale)

    (* high scores = better)

  13. Cognitive assessment XI: Stroop Color and Word Test

    Time frame: Up to 8 weeks after intervention

    • Word, Score range: 0 - 140* (Units on a Scale)
    • Color, Score range:0 - 120* (Units on a Scale)
    • Color-Word, Score range:0 - 80* (Units on a Scale)

    (* high scores = better)

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

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 18, 2023
Registry last updated
Apr 29, 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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