Trial · NCT03875638
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Neuropsychological Test Battery (NTB) | From enrollment until the end of the treatment periods at 5 months | Our primary cognitive outcome measure will be the mean z-score change relative to baseline on the NTB |
| Primary | Transcranial magnetic stimulation (TMS) resting motor threshold | From enrollment until the end of the treatment periods at 5 months | Our primary TMS electrophysiological outcome measure of cerebral cortical excitability will be the change in the TMS resting input-output curve inflection point |
| Primary | Transcranial magnetic stimulation (TMS)-evoked electroencephalogram (EEG) hypersynchrony | From enrollment until the end of the treatment periods at 5 months | Our primary electrophysiological measure of cerebral network excitability will be TMS-evoked EEG hypersynchrony with stimulation of parietal cortex |
| Primary | Resting-state electroencephalogram (EEG) beta band power | From enrollment until the end of the treatment periods at 5 months | Our primary electrophysiological measure of local network function will be resting-state EEG power in the beta band |
| Primary | Resting-state electroencephalogram (EEG) beta band connectivity | From enrollment until the end of the treatment periods at 5 months | Our primary electrophysiological measure of brain network interactions will be resting-state EEG functional connectivity in the beta band |
| Primary | Default-mode network resting-state functional magnetic resonance imaging (fMRI) functional connectivity | From enrollment until the end of the treatment periods at 5 months | Our primary imaging measure of integrity of macroscopic brain networks will be mean resting-state fMRI functional connectivity within the default-mode network |
| Primary | Change in motor evoked potential (MEP) amplitude | From enrollment until the end of the treatment periods at 5 months | Our primary transcranial magnetic stimulation (TMS) measure of plasticity in cortical excitability will be the change in MEP amplitude 10 minutes after intermittent theta-burst stimulation |
| Primary | Change in beta power after theta-burst stimulation | From enrollment until the end of the treatment periods at 5 months | Our primary transcranial magnetic stimulation (TMS) measure of plasticity in cortical oscillations will be change in resting-state electroencephalogram (EEG) beta power after theta-burst stimulation |
| Other | Transcranial magnetic stimulation (TMS)-evoked N45 electroencephalogram (EEG) potential | From enrollment until the end of the treatment periods at 5 months | The change in the N45 component of the TMS-evoked EEG potential with motor cortex stimulation, will serve as a measure of target engagement with levetiracetam therapy, and as a covariate in subsequent analyses. |
| Other | Interictal Epileptiform Discharges | Baseline | The presence or absence of interictal epileptiform discharges on the baseline ambulatory 24-hour EEG or the baseline high-density EEG will be used a primary baseline measure of cortical hyperexcitability |
| Other | Baseline motor cortical hyperexcitability | Baseline | TMS-EMG Input-Output Curve Inflection Point: This is a relatively novel measure of hyperexcitability that shows increased excitability between AD and age-matched older adults. We will divide participants into tertiles based on their IO curve inflection point, and assess LEV effects by tertiles |
| Other | Baseline TMS-EEG Parietal Cortical Excitability | Baseline | Participants will be classified by baseline parietal cortical excitability as measured by TMS-EEG using source space modeling. We will use the same ROIs and time windows as used in our publication from this same dataset. This analysis provides a complementary measure of cortical excitability in a disease-relevant brain region. We will divide participants into tertiles and assess LEV effects by tertile. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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