Trial · NCT07912931
Electrophysiological Dose-Response to Anterior Thalamic Deep Brain Stimulation in Drug-Resistant Focal Epilepsy
NCT07912931, Not applicable, Not yet recruiting, Yonsei University
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Electrophysiological Dose-Response to Anterior Thalamic Deep Brain Stimulation in Drug-Resistant Focal Epilepsy. Trials, record NCT07912931. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07912931
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Electrophysiological Dose-Response to Anterior Thalamic Deep Brain Stimulation in Drug-Resistant Focal Epilepsy
- NCT number
- NCT07912931
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 10 participants, estimated
- Lead sponsor
- Yonsei University
- Conditions
- Drug Resistant Epilepsy, Focal Epilepsy
- Interventions
- Anterior thalamic deep brain stimulation with a standardized amplitude schedule and acute stimulation challenges
- First posted
- 2026-11-03
- Last updated
- 2026-11-03
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07912931
GET https://conductscience.org/api/trials/v1/NCT07912931/registered?page=2