Closed-Loop Brain Stimulation for Cognitive Decline
This study is looking at whether a non-invasive brain stimulation called theta burst stimulation (TBS) can improve cognitive abilities in healthy adults and older adults with mild cognitive impairment (MCI). You would play a cognitive video game while a brain-computer interface (BCI) analyzes your brain activity. The BCI then delivers TBS using either a real coil (Closed-loop TBS or Open-loop TBS) or a sham (inactive) coil (Sham TBS). Researchers want to see if TBS can restore cognitive functions and if Closed-loop TBS works better than Open-loop TBS. The study plans to enroll 180 participants aged 18 to 90 years old. Success will be measured by your performance on the video game and cognitive assessments like the Montreal Cognitive Assessment.
- Study design
- This interventional study plans to enroll 180 participants. It compares three different ways of delivering theta burst stimulation (TBS): Sham TBS, Closed-loop TBS, and Open-loop TBS.
- What's involved
- You would perform cognitively demanding video game tasks. Behavioral performance and BCI accuracy will be measured up to 1 hour after the intervention, and cognitive assessments will be done up to 8 weeks after the intervention.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your cognitive abilities will be assessed up to 8 weeks after the intervention.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Closed-Loop Brain Stimulation as a Potential Intervention for Cognitive Decline
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- José del R. Millán, PhD · PRINCIPAL_INVESTIGATOR · University of Texas at Austin
- Robin Hilsabeck, PhD, ABPP · PRINCIPAL_INVESTIGATOR · University of Texas at Austin
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- 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.
- 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 I: Montreal Cognitive AssessmentUp to 8 weeks after intervention
Telephone version, Score range: 0 - 22\* (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 IV: Animal NamingUp to 8 weeks after intervention
Score range: 0 - 40\* (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)
- 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 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)
- Cognitive assessment X: Controlled Oral Word Association TestUp to 8 weeks after intervention
Score range: 0 - 80\* (Units on a Scale) (\* high scores = better)
- 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)