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

Sponsor

University of Texas at Austin (Other)

Overall Status

Recruiting

CT.gov ID

NCT05907343

Collaborator

(none)

180

Enrollment

Location

Arms

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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 we can 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.

Condition or Disease	Intervention/Treatment	Phase
Mild Cognitive Impairment	Device: Sham TBS Device: Closed-loop TBS Device: Open-loop TBS	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 31, 2023

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Sham TBS	Device: Sham TBS 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.
Active Comparator: Closed-Loop TBS	Device: Closed-loop TBS 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.
Active Comparator: Open-Loop TBS	Device: Open-loop TBS 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.

Arm

Intervention/Treatment

Active Comparator: Sham TBS

Device: Sham TBS

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.

Active Comparator: Closed-Loop TBS

Device: Closed-loop TBS

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.

Active Comparator: Open-Loop TBS

Device: Open-loop TBS

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.

Outcome Measures

Primary Outcome Measures

Behavioral performance [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.
BCI classifier output [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).
Cognitive assessment score [Up to 8 weeks after intervention]
The cognitive assessment score reflects the cognitive performance using standardized neuropsychological measures. Tests that measure cognitive functions such as attention, processing speed, executive functions will be used to evaluate the therapeutic effects in subjects.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Health Discovery Building	Austin	Texas	United States	78712

Sponsors and Collaborators

University of Texas at Austin

Investigators

Principal Investigator: José del R. Millán, PhD, University of Texas at Austin
Principal Investigator: Robin Hilsabeck, PhD, ABPP, University of Texas at Austin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jose del R. Millan, Professor, University of Texas at Austin

ClinicalTrials.gov Identifier:

NCT05907343

Other Study ID Numbers:

STUDY00003055

First Posted:

Jun 18, 2023

Last Update Posted:

Jun 18, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Keywords provided by Jose del R. Millan, Professor, University of Texas at Austin

Additional relevant MeSH terms:

Cognitive Dysfunction

Study Results

No Results Posted as of Jun 18, 2023