Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05907343 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoints removed 13 → 1 primary endpoints
See other at-risk trials from University of Texas at Austin

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Re-verified, no change to tracked fieldsv6
  2. Notable Primary endpoint(s) modifiedv5 Show 5 more changesShow less
    • Interventions modified
    • Trial arms changed: 3 → 2
    • Eligibility criteria shortened, about 28 words
    • Secondary endpoints expanded, about 25 words
    • Collaborators expanded, about 6 words
  3. Notable Primary and study completion dates: Dec 31, 2026 to Oct 31, 2027v4
  4. Minor Re-verified, no change to tracked fieldsv3
  5. Notable Primary endpoints: 3 to 13v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical study is to investigate the effectiveness of non-invasive stimulation to enhance cognitive control abilities in older adults with and without cognitive impairment. The main questions it aims to answer are: * whether it is possible to restore various cognitive functions in older adults 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 closed-loop and open-loop TBS using the outcome metrics described below to see how much cognitive restorations is achievable with each stimulation modality.
Trial Details
NCT Number NCT05907343
Lead Sponsor University of Texas at Austin
Collaborators: Texas Alzheimer's Research and Care Consortium
Conditions
(from sponsor)
Mild Cognitive Impairment, Alzheimer Dementia (AD)
Related terms Alzheimer Disease, Cognitive Dysfunction, Memory Disorders
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov