Trial · NCT07912931
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Stimulation-Induced Change in Anterior Thalamic Slow-Gamma (20-50 Hz) Power at 2.0, 3.5 and 5.0 mA | 3 months after stimulation activation | Stimulation-induced change in anterior thalamic local field potential (LFP) power in the 20-50 Hz slow-gamma band, quantified as ΔSG = ln(P\_ON/P\_OFF), where P\_ON and P\_OFF are integrated band power during 60 s of stable continuous stimulation and during the immediately preceding 2-minute stimulation-off baseline, respectively, recorded with the implanted device (BrainSense Streaming). At the 3-month visit, ΔSG is measured at 2.0, 3.5 and 5.0 mA, with at least two repetitions per amplitude in a counterbalanced order; repeats are averaged within each hemisphere and then across hemispheres. Participants who cannot tolerate bilateral 5.0 mA are tested at the highest amplitude tolerated on both sides and analyzed separately in prespecified available-dose sensitivity analyses. Zero indicates no change; negative values indicate suppression. |
| Secondary | Test-Retest Agreement of the Acute Slow-Gamma Response | At stimulation activation, and 1 and 3 months after activation | Intraclass correlation coefficient (two-way mixed-effects, absolute agreement, single measure) between the two repeated measurements of ΔSG (defined in the primary outcome) at the same amplitude and visit, calculated for each amplitude at each visit. |
| Secondary | Difference in Slow-Gamma Response Between 3.5 and 2.0 mA at 1 Month | 1 month after stimulation activation | Within-participant difference in repeat-averaged ΔSG (defined in the primary outcome) between 3.5 and 2.0 mA (3.5 minus 2.0 mA), tested at the same visit as supportive replication of the primary dose-response. |
| Secondary | Amplitude-Response Slope of the Slow-Gamma Response | 3 months after stimulation activation | Per-participant slope of repeat-averaged ΔSG (defined in the primary outcome) against stimulation amplitude across 2.0, 3.5 and 5.0 mA, in log ratio per mA. |
| Secondary | Change in Slow-Gamma Response to 2.0 mA Stimulation Across Visits | At stimulation activation, and 1 and 3 months after activation | Repeat-averaged ΔSG (defined in the primary outcome) at 2.0 mA at each visit, each normalized to its own local stimulation-off baseline, describing how the response to the same amplitude changes with cumulative chronic stimulation. |
| Secondary | Device-Matched Narrow-Band Power Change During Acute Challenges | At stimulation activation, and 1 and 3 months after activation | Power in an approximately 5-Hz band centered on each participant's chronic sensing frequency, recomputed offline from the same challenge recordings and expressed as ln(ON/OFF). Its agreement with ΔSG is assessed by Spearman correlation and direction concordance. |
| Secondary | Change in Chronic Narrow-Band Anterior Thalamic Power During the First 3 Months of Stimulation | From the stimulation-free period after implantation to 3 months after stimulation activation | Narrow-band power stored by the device during daily life (BrainSense Timeline), normalized to the stimulation-free period after implantation; change from a prespecified early stimulation window to a window at month 3. Its relation to ΔSG is assessed by Spearman correlation. |
| Secondary | Percent Reduction in Monthly Seizure Frequency in Months 7-12 | Preoperative baseline and months 7-12 after stimulation activation | (Baseline monthly seizure frequency - mean monthly seizure frequency in months 7-12) / baseline × 100, from seizure diaries; positive values indicate reduction. Baseline uses a prospective diary of at least 8 weeks (target 12 weeks) before implantation where available, and otherwise systematically recorded diaries or medical records. Its relation to the acute and chronic LFP measures is assessed by Spearman correlation. |
| Secondary | Overlap of the Modeled Stimulation Field With the Anterior Thalamic Nucleus and Mammillothalamic Tract | Postoperative imaging, modeled for challenge conditions at activation and 1 and 3 months after activation | Overlap of the modeled electric field (volume of tissue activated) with the anterior thalamic nucleus and with the mammillothalamic tract for each challenge condition, expressed as the percentage of each structure's volume, estimated with Lead-DBS from postoperative CT co-registered to preoperative MRI. Active-contact location and diffusion tensor imaging (DTI) structural connectivity are analyzed as additional explanatory measures. Relation to ΔSG is assessed by Spearman correlation. |
| Other | Percent Reduction in Focal-to-Bilateral Tonic-Clonic Seizure Frequency | Preoperative baseline and months 7-12 after stimulation activation | Same calculation as the main seizure outcome, restricted to focal-to-bilateral tonic-clonic seizures, in participants who have them at baseline; prespecified sensitivity anchor |
| Other | Percent Reduction in Caregiver-Corroborated or Witnessed Disabling Seizure Frequency | Preoperative baseline and months 7-12 after stimulation activation | Same calculation, restricted to disabling seizures witnessed or confirmed by a cohabiting or primary caregiver; prespecified sensitivity anchor |
| Other | Burden of Device-Recorded Electrographic Seizure-Like Events and Epileptiform Transients | From implantation to 12 months after stimulation activation | Number of electrographic seizure-like events or epileptiform transients per hour of analyzable recording (per analyzable segment for event-triggered recordings), using prespecified criteria. Where possible, events are adjudicated independently by two clinical neurophysiologists blinded to clinical outcomes. Calculated only for participants with raw time-domain or event-specific LFP recordings; agreement with diary-based seizure outcomes is assessed. |
| Other | Proportion of Planned Acute Challenges Completed With Two Valid Repeats at Each Amplitude | At stimulation activation, and 1 and 3 months after activation | Challenges with two valid repeats at every planned amplitude, divided by challenges planned |
| Other | Proportion of Participants Reaching 5.0 mA on Both Sides | 3 months after stimulation activation | Reasons for not reaching it (adverse event, seizure worsening, clinical judgment or technical limitation) are reported |
| Other | Proportion of Recordings With Analyzable Bilateral Local Field Potential Signals | Within 1 week after implantation, and at stimulation activation and 1 and 3 months after activation | Recordings meeting prespecified signal-quality criteria in both hemispheres, divided by recordings performed |
| Other | Proportion of Participants With Usable Bilateral Chronic Sensing Data | From implantation to 3 months after stimulation activation | Participants whose chronic narrow-band data meet prespecified coverage in both hemispheres |
| Other | Number of Protocol Modifications to the Amplitude Schedule | From stimulation activation to 3 months after activation | Changes made for clinical safety during the first 3 months after activation |
| Other | Number of Participants With Adverse Events Related to Study Procedures | From consent to 12 months after stimulation activation | Graded with the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 |
| Other | Change in Korean Montreal Cognitive Assessment (K-MoCA) Score | Before implantation and 3 and 12 months after stimulation activation | Range 0-30; higher scores indicate better cognition |
| Other | Change in Quality of Life in Epilepsy Inventory-31 (QOLIE-31) Total Score | Before implantation and 3 and 12 months after stimulation activation | Range 0-100; higher scores indicate better quality of life |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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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