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

Not Applicable
Recruiting
Conditions
Mild Cognitive Impairment
Interventions
Device: Closed-loop TBS
Device: Open-loop TBS
Device: Sham TBS
Registration Number
NCT05907343
Lead Sponsor
University of Texas at Austin
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
180
Inclusion Criteria
  • Cognitively normal younger 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
  • Cognitively normal 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. 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)

    1. Ages between 60 to 90 years
    2. Diagnosis of MCI according to the National Institute on Aging - Alzheimer's Association (NIA-AA) criteria
    3. Good general health
    4. Normal or corrected vision
    5. Completed elementary school education or able to understand middle school level experiment instructions
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Exclusion Criteria
  1. Neurological or psychiatric diseases (e.g., personal history of epilepsy/seizure brain damage, multiple sclerosis, schizophrenia, substance use disorder, etc.).
  2. Current use of psychotropic medications with cognitive side effects (e.g., benzodiazepines, anticonvulsants, antipsychotics, etc.)
  3. Current use of cognitive enhancing medications (e.g., Adderall, Memantine, etc.)
  4. Factors hindering EEG acquisition and TMS delivery (e.g., skin infection, wounds, dermatitis, etc.)
  5. Factors hindering MRI acquisition (e.g., implants, metallic tattoos, etc.)
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Closed-Loop TBSClosed-loop TBS-
Open-Loop TBSOpen-loop TBS-
Sham TBSSham TBS-
Primary Outcome Measures
NameTimeMethod
Cognitive assessment VII: Southwestern Assessment of Processing SpeedUp to 8 weeks after intervention

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

(\* high scores = better)

Cognitive assessment X: Controlled Oral Word Association TestUp to 8 weeks after intervention

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

(\* high scores = better)

Behavioral performance of the video game taskUp 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.

Cognitive assessment I: Montreal Cognitive AssessmentUp to 8 weeks after intervention

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

(\* high scores = better)

Cognitive assessment IV: Animal NamingUp to 8 weeks after intervention

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

(\* high scores = better)

Cognitive assessment II: Hopkins Adult Reading TestUp to 8 weeks after intervention

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

(\* high scores = better)

Cognitive assessment III: Multilingual Naming TestUp to 8 weeks after intervention

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

(\* high scores = better)

Cognitive assessment V: Number SpanUp 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)

Cognitive assessment VI: Trail Making TestUp to 8 weeks after intervention

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

(\*\* high scores = worse)

Accuracy of the BCI classifier outputUp 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).

Cognitive assessment XI: Stroop Color and Word TestUp 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)

Cognitive assessment VIII: Hopkins Verbal Learning Test-RevisedUp 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)

Cognitive assessment IX: Brief Visuospatial Memory Test-RevisedUp 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)

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Health Discovery Building

🇺🇸

Austin, Texas, United States

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