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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham TBS | Active Comparator |
| |
| Closed-Loop TBS | Active Comparator |
| |
| Open-Loop TBS | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Behavioral performance of the video game task | 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. | Up to 1 hour after intervention |
| Accuracy of the BCI classifier output | 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). | Up to 1 hour after intervention |
| Cognitive assessment I: Montreal Cognitive Assessment | Telephone version, Score range: 0 - 22* (Units on a Scale) (* high scores = better) | Up to 8 weeks after intervention |
| Cognitive assessment II: Hopkins Adult Reading Test | Score range: 70 - 131* (Units on a Scale) (* high scores = better) | Up to 8 weeks after intervention |
| Cognitive assessment III: Multilingual Naming Test | Score range: 0 - 32* (Units on a Scale) (* high scores = better) | Up to 8 weeks after intervention |
| Cognitive assessment IV: Animal Naming | Score range: 0 - 40* (Units on a Scale) (* high scores = better) | Up to 8 weeks after intervention |
| Cognitive assessment V: Number Span |
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Inclusion Criteria:
Cognitively normal younger adults
Cognitively normal older adults
Older adults with mild cognitive impairment (MCI)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| José del R. Millán, PhD | Contact | 512-232-8111 | jose.millan@austin.utexas.edu | |
| Minsu Zhang | Contact | 512-840-9310 | minsuzhang@utexas.edu |
| Name | Affiliation | Role |
|---|---|---|
| José del R. Millán, PhD | University of Texas at Austin | Principal Investigator |
| Robin Hilsabeck, PhD, ABPP | University of Texas at Austin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Discovery Building | Recruiting | Austin | Texas | 78712 | United States |
All anonymized data will be made available by the online publication date. These data will be placed in public servers for any interested researcher to access it.
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Data will become permanently available by the online publication date.
Any interested researcher will have access.
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D008569 | Memory Disorders |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
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| 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. |
|
(* high scores = better) |
| Up to 8 weeks after intervention |
| Cognitive assessment VI: Trail Making Test | Parts A and B, Score range: 10 - 300** (Units on a Scale) (** high scores = worse) | Up to 8 weeks after intervention |
| Cognitive assessment VII: Southwestern Assessment of Processing Speed | Score range: 0 - 75* (Units on a Scale) (* high scores = better) | Up to 8 weeks after intervention |
| Cognitive assessment VIII: Hopkins Verbal Learning Test-Revised |
(* high scores = better) | Up to 8 weeks after intervention |
| Cognitive assessment IX: Brief Visuospatial Memory Test-Revised |
(* high scores = better) | Up to 8 weeks after intervention |
| Cognitive assessment X: Controlled Oral Word Association Test | Score range: 0 - 80* (Units on a Scale) (* high scores = better) | Up to 8 weeks after intervention |
| Cognitive assessment XI: Stroop Color and Word Test |
(* high scores = better) | Up to 8 weeks after intervention |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |