RESTORE: Restoring State-dependent Thalamocortical Oscillations in Epilepsy
NCT07927985, Not applicable, Not yet recruiting, Gregory Worrell
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | RESTORE: Restoring State-dependent Thalamocortical Oscillations in Epilepsy | ClinicalTrials.gov |
| NCT number | NCT07927985 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 10 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Gregory Worrell | ClinicalTrials.gov |
| Conditions | Epilepsy, Drug Resistant | ClinicalTrials.gov |
| Interventions | Sham Mediodorsal Thalamic (MD) Deep Brain Stimulation + Centromedian Thalamic (CM) Deep Brain Stimulation, Low-Frequency Mediodorsal Thalamic Deep Brain Stimulation, High-Frequency Mediodorsal Thalamic Deep Brain Stimulation, Mediodorsal Thalamic Deep Brain Stimulation using optimal settings | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Number of Participants With a Device, Procedure, or Stimulation-Related Serious Adverse Events | From device implantation through Month 21 | Number of participants who experience at least one serious adverse event assessed by the investigator as related to the Cadence Biomarker Targeted Stimulation System, the device-implantation procedure, or delivered deep brain stimulation. | ClinicalTrials.gov |
| Secondary | Change in Monthly Disabling Seizure Frequency | Baseline, 3, 6, 9, 12 and 21 months post-implant | Percent change in number of disabling seizures as reported in seizure diary. Disabling seizures include generalized tonic-clonic seizures, tonic seizures, atonic seizures, focal-to-bilateral tonic-clonic seizures, and other seizure types associated with loss of awareness, falls, injury risk, or clinically significant functional impairment. | ClinicalTrials.gov |
| Secondary | Percentage of Participants With at Least a 50% Reduction in Disabling Seizure Frequency | Baseline, 3, 6, 9, 12 and 21 months post-implant | Percentage of participants whose 28-day disabling seizure frequency is at least 50% lower than baseline during each post-baseline assessment interval. | ClinicalTrials.gov |
| Secondary | Percentage of Participants Free of Disabling Seizures | Baseline, 3, 6, 9, 12 and 21 months post-implant | Percentage of participants with no diary-recorded disabling seizures during each post-baseline assessment interval. | ClinicalTrials.gov |
| Secondary | Change in Liverpool Seizure Severity Scale 2.0 Total Score | Baseline, 3, 6, 9, 12 and 21 months post-implant | The Liverpool Seizure Severity Scale 2.0 is a patient-reported measure of the severity of the participant's most severe seizure during the previous 4 week period. The revised scoring system uses responses to 12 ictal and postictal severity items to calculate a single score that is linearly transformed to a scale from 0 to 100. A score of 0 represents no seizures and a score of 100 represents the most severe possible seizure; higher scores indicate greater seizure severity. A decrease from baseline indicates improvement. | ClinicalTrials.gov |
| Secondary | Change in Quality of Life in Epilepsy-31 Total Score | Baseline, 3, 6, 9, 12 and 21 months post-implant | The Quality of Life in Epilepsy-31 is a 31-item, patient-reported measure of epilepsy-specific health-related quality of life. It includes seven multi-item scales: seizure worry, overall quality of life, emotional well-being, energy/fatigue, cognitive functioning, medication effects, and social functioning. Item responses are converted to 0-to-100 scale scores according to the QOLIE-31 scoring manual. The overall score is calculated as a weighted average of the seven multi-item scale scores and ranges from 0 to 100. Higher scores indicate better health-related quality of life; a positive change from baseline indicates improvement. | ClinicalTrials.gov |
| Secondary | Change in NIH Toolbox Flanker Inhibitory Control and Attention Test Score | Baseline, 3, 6, 9, 12 and 21 months post-implant | The NIH Toolbox Flanker Inhibitory Control and Attention test measures attention and inhibitory control by requiring the participant to indicate the direction of a central target while ignoring flanking stimuli that may be congruent or incongruent. The computed score combines response accuracy and reaction time and ranges from 0 to 10. When accuracy is below 80%, the computed score is based on accuracy alone; when accuracy is 80% or higher, accuracy and reaction time are combined. Higher scores indicate better performance, reflecting greater accuracy and, among sufficiently accurate responses, faster reaction time; a positive change from baseline indicates improvement. | ClinicalTrials.gov |
| Secondary | Change in Free Recall Memory Score | Baseline, 3, 6, 9, 12 and 21 months post-implant | Change from baseline in the number of protocol-specified proper nouns correctly recalled from a 12-item list. Scores range from 0 to 12; higher scores indicate better free recall. | ClinicalTrials.gov |
| Secondary | Change in NIH Toolbox Picture Sequence Memory Test Score | Baseline, 3, 6, 9, 12 and 21 months post-implant | The NIH Toolbox Picture Sequence Memory Test is an examiner-administered measure of episodic memory. The participant views an ordered series of pictures and then reconstructs the sequence. 1 point is awarded for each pair placed in the correct relative order; higher scores indicate better memory and a positive change indicates improvement. | ClinicalTrials.gov |
| Secondary | Change in NIH Toolbox Picture Vocabulary Test score | Baseline, 3, 6, 9, 12 and 21 months post-implant | The NIH Toolbox Picture Vocabulary Test is a computer-adaptive measure of receptive vocabulary. The participant hears a word and selects the picture that best matches it from four choices; subsequent items are selected based on prior responses. Responses are scored using item-response theory to estimate vocabulary ability. Higher scores indicate better receptive vocabulary, and a positive change from baseline indicates improvement. | ClinicalTrials.gov |
| Secondary | Change in Beck Depression Inventory Total Score | Baseline, 3, 6, 9, 12 and 21 months post-implant | The Beck Depression Inventory-II (BDI-II) is a 21-item, self-reported measure of depressive symptoms experienced during the past 2 weeks. Each item is rated from 0 to 3, and item ratings are summed to produce a total score from 0 to 63. Higher scores indicate greater depressive symptom severity. Common interpretive ranges are 0-13, minimal; 14-19, mild; 20-28, moderate; and 29-63, severe. A negative change from baseline indicates improvement. | ClinicalTrials.gov |
| Secondary | Change in Beck Anxiety Inventory Total Score | Baseline, 3, 6, 9, 12 and 21 months post-implant | The Beck Anxiety Inventory (BAI) is a 21-item, self-reported measure of anxiety symptoms experienced during the past week. Each item is rated from 0 (not at all) to 3 (severely), and item ratings are summed to produce a total score from 0 to 63. Higher scores indicate greater anxiety symptom severity. Common interpretive ranges are 0-7, minimal anxiety; 8-15, mild anxiety; 16-25, moderate anxiety; and 26-63, severe anxiety. A negative change from baseline indicates improvement. | ClinicalTrials.gov |
| Secondary | Number of Participants With a Device Performance Event | Post-implementation through 21 months | Number of participants with at least one device malfunction, technical problem, lead or system revision, explant, or permanent discontinuation of stimulation attributable to device performance. | ClinicalTrials.gov |
| Secondary | Change in Epworth Sleepiness Scale Total Score | Baseline, 3, 6, 9, 12 and 21 months post-implant | The Epworth Sleepiness Scale (ESS) is an 8-item, self-reported measure of usual daytime sleep propensity in common situations. Each situation is rated from 0 (would never doze) to 3 (high chance of dozing), and item ratings are summed to produce a total score from 0 to 24. Higher scores indicate greater daytime sleepiness. Common interpretive ranges are 0-10, normal; 11-14, mild sleepiness; 15-17, moderate sleepiness; and 18-24, severe sleepiness. A negative change from baseline indicates improvement. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Picture Order Memory Test | Secondary outcome | ConductCognition |
| Vocabulary Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)