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

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Sham TBS

Closed-loop TBS

Open-loop TBS

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring MCI, Older adults, Cognitive control, Memory impairment

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.)

Sites / Locations

Health Discovery BuildingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Sham TBS

Closed-Loop TBS

Open-Loop TBS

Arm Description

Outcomes

Primary Outcome Measures

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.

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).

Cognitive assessment I: Montreal Cognitive Assessment

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

Cognitive assessment II: Hopkins Adult Reading Test

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

Cognitive assessment III: Multilingual Naming Test

Score range: 0 - 32* (Units on a Scale) (* high scores = better)

Cognitive assessment IV: Animal Naming

Score range: 0 - 40* (Units on a Scale) (* high scores = better)

Cognitive assessment V: Number Span

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 Test

Parts A and B, Score range: 10 - 300** (Units on a Scale) (** high scores = worse)

Cognitive assessment VII: Southwestern Assessment of Processing Speed

Score range: 0 - 75* (Units on a Scale) (* high scores = better)

Cognitive assessment VIII: Hopkins Verbal Learning Test-Revised

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-Revised

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 Test

Score range: 0 - 80* (Units on a Scale) (* high scores = better)

Cognitive assessment XI: Stroop Color and Word Test

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT05907343

First Posted

June 7, 2023

Last Updated

June 27, 2023

Sponsor

University of Texas at Austin

1. Study Identification

Unique Protocol Identification Number

NCT05907343

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 31, 2023 (Actual)

Primary Completion Date

December 31, 2026 (Anticipated)

Study Completion Date

December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Texas at Austin

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

Yes

5. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Cognitive Impairment

Keywords

MCI, Older adults, Cognitive control, Memory impairment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sham TBS

Arm Type

Active Comparator

Arm Title

Closed-Loop TBS

Arm Type

Active Comparator

Arm Title

Open-Loop TBS

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

Sham TBS

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Closed-loop TBS

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Open-loop TBS

Intervention Description

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.

Primary Outcome Measure Information:

Title

Behavioral performance of the video game task

Description

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

Title

Accuracy of the BCI classifier output

Description

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

Title

Cognitive assessment I: Montreal Cognitive Assessment

Description

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

Time Frame