RECRUITING

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

Conditions

Mild Cognitive Impairment MCI Older adults Cognitive control Memory impairment

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-05-31

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05907343

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Cognitively normal younger adults 1. Ages between 18 to 35 years 2. Good general health 3. Normal or corrected vision 4. Completed elementary school education or able to understand middle school level experiment instructions * Cognitively normal older adults 1. Ages between 60 to 90 years 2. Good general health 3. Normal or corrected vision 4. Completed elementary school education or able to understand middle school level experiment instructions 5. 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) 1. Ages between 60 to 90 years 2. Diagnosis of MCI according to the National Institute on Aging - Alzheimer's Association (NIA-AA) criteria 3. Good general health 4. Normal or corrected vision 5. Completed elementary school education or able to understand middle school level experiment instructions	1. Neurological or psychiatric diseases (e.g., personal history of epilepsy/seizure brain damage, multiple sclerosis, schizophrenia, substance use disorder, etc.). 2. Current use of psychotropic medications with cognitive side effects (e.g., benzodiazepines, anticonvulsants, antipsychotics, etc.) 3. Current use of cognitive enhancing medications (e.g., Adderall, Memantine, etc.) 4. Factors hindering EEG acquisition and TMS delivery (e.g., skin infection, wounds, dermatitis, etc.) 5. Factors hindering MRI acquisition (e.g., implants, metallic tattoos, etc.)

Inclusion Criteria

Exclusion Criteria

* Cognitively normal younger adults
1. Ages between 18 to 35 years
2. Good general health
3. Normal or corrected vision
4. Completed elementary school education or able to understand middle school level experiment instructions
* Cognitively normal older adults
1. Ages between 60 to 90 years
2. Good general health
3. Normal or corrected vision
4. Completed elementary school education or able to understand middle school level experiment instructions
5. 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)
1. Ages between 60 to 90 years
2. Diagnosis of MCI according to the National Institute on Aging - Alzheimer's Association (NIA-AA) criteria
3. Good general health
4. Normal or corrected vision
5. Completed elementary school education or able to understand middle school level experiment instructions

1. Neurological or psychiatric diseases (e.g., personal history of epilepsy/seizure brain damage, multiple sclerosis, schizophrenia, substance use disorder, etc.).
2. Current use of psychotropic medications with cognitive side effects (e.g., benzodiazepines, anticonvulsants, antipsychotics, etc.)
3. Current use of cognitive enhancing medications (e.g., Adderall, Memantine, etc.)
4. Factors hindering EEG acquisition and TMS delivery (e.g., skin infection, wounds, dermatitis, etc.)
5. Factors hindering MRI acquisition (e.g., implants, metallic tattoos, etc.)

Contacts and Locations

Study Contact

José del R. Millán, PhD

CONTACT

512-232-8111

jose.millan@austin.utexas.edu

Minsu Zhang

CONTACT

512-840-9310

minsuzhang@utexas.edu

Principal Investigator

José del R. Millán, PhD

PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Robin Hilsabeck, PhD, ABPP

PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Study Locations (Sites)

Health Discovery Building

Austin, Texas, 78712

United States

Collaborators and Investigators

Sponsor: University of Texas at Austin

José del R. Millán, PhD, PRINCIPAL_INVESTIGATOR, University of Texas at Austin
Robin Hilsabeck, PhD, ABPP, PRINCIPAL_INVESTIGATOR, University of Texas at Austin

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-31

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2023-05-31

Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

MCI
Older adults
Cognitive control
Memory impairment

Additional Relevant MeSH Terms

Mild Cognitive Impairment