Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07568860 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Sleep-Driven Adaptive Neuromodulation in Lennox-Gastaut Syndrome

Study acronym: ADAPT LGS
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Sep 30, 2030 → Dec 30, 2030
See other at-risk trials from University of Minnesota

Record History

See every version on ClinicalTrials.gov ↗

  1. Start date: Oct 1, 2026 to Jan 1, 2027 Show 5 more changesShow less
    • Primary endpoints: details revised at 1 of 11 entries
    • Primary completion pushed from Sep 30, 2030 to Dec 30, 2030
    • Study completion pushed from Sep 30, 2031 to Dec 30, 2031
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: details revised at 2 of 3 entries
  2. Re-verified, no change to tracked fieldsv2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 trial is to explore a new type of personalized brain stimulation that works during day time and night time hours using the Medtronic Percept Deep Brain Stimulation (DBS) device in patients with Lennox-Gastaut Syndrome. The main question(s) this study aims to answer is: 1. Does using the personalized DBS reduce motor seizures compared to conventional DBS? 2. Is the number of seizures reported by caregivers different for patients using the personalized DBS? 3. How often do patients using the personalized DBS experience undesired side effects? Researchers will compare the personalized DBS that works night time, personalized DBS device that works during the day time, and conventional DBS. Participants will: 1. Have their seizures and sleep patterns recorded for 3-months 2. Assess their neurocognitive function 3. Answer questionnaires about communication, movement, and sleep quality 4. Wear a sleep headband and seizure warning watch for 5 nights 5. Complete a mood and sleep assessment 6. Have a 3T and possibly 7T MRI 7. Be implanted with stereo-encephalography and undergo 3\~5 days of monitoring 8. Have the stereo-encephalography taken out 9. Receive DBS implantation through surgery and have several months of stimulation and no stimulation periods 10. Have routine clinical visits to check on healing after surgery 11. Have their caregiver help them keep a dairy about their seizures, sleep and quality of life
Trial Details
NCT Number NCT07568860
Lead Sponsor University of Minnesota
Conditions
(from sponsor)		 Lennox Gastaut Syndrome (LGS), Epilepsy
Related terms Epilepsy, Lennox Gastaut Syndrome
Enrollment 4 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov