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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity of Texas at Austin

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Cognitively normal younger adults

Ages between 18 to 35 years

Good general health

Normal or corrected vision

Disqualifiers

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.)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: Sham TBSActive comparator 1 intervention
Group B: Closed-Loop TBSActive comparator 1 intervention
Group C: Open-Loop TBSActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 1 hour after intervention
2

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).

Time frame
Up to 1 hour after intervention
3

Cognitive assessment I: Montreal Cognitive Assessment

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

Time frame
Up to 8 weeks after intervention
4

Cognitive assessment II: Hopkins Adult Reading Test

Score range: 70 - 131\* (Units on a Scale) (\* high scores = better)

Time frame
Up to 8 weeks after intervention

Secondary outcomes

Other outcomes

Sponsors and contacts

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