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Recruiting NCT05907343

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

No phase Interventional Mild Cognitive Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sham TBS, Closed-loop TBS, Open-loop TBS.
Who it may be relevant to
Registry conditions: Mild Cognitive Impairment. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • 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.
  • 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.
  • 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.

Primary outcome measures

  • Behavioral performance of the video game task [Time frame: Up to 1 hour after intervention]
  • Accuracy of the BCI classifier output [Time frame: Up to 1 hour after intervention]
  • Cognitive assessment I: Montreal Cognitive Assessment [Time frame: Up to 8 weeks after intervention]
  • Cognitive assessment II: Hopkins Adult Reading Test [Time frame: Up to 8 weeks after intervention]
  • Cognitive assessment III: Multilingual Naming Test [Time frame: Up to 8 weeks after intervention]
  • Cognitive assessment IV: Animal Naming [Time frame: Up to 8 weeks after intervention]
  • Cognitive assessment V: Number Span [Time frame: Up to 8 weeks after intervention]
  • Cognitive assessment VI: Trail Making Test [Time frame: Up to 8 weeks after intervention]
  • Cognitive assessment VII: Southwestern Assessment of Processing Speed [Time frame: Up to 8 weeks after intervention]
  • Cognitive assessment VIII: Hopkins Verbal Learning Test-Revised [Time frame: Up to 8 weeks after intervention]

Eligibility criteria

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.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Health Discovery Building — Austin

Identifiers

NCT: NCT05907343 · STUDY00003055

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗