Condition or disease | Intervention/treatment | Phase |
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Epilepsy | Device: Medtronic Summit System, Olympus | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Epilepsy |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Human Safety and Feasibility Study of Neurophysiologically Based Brain State Tracking and Modulation in Focal Epilepsy |
Actual Study Start Date : | July 10, 2019 |
Estimated Primary Completion Date : | April 30, 2022 |
Estimated Study Completion Date : | December 31, 2022 |
Arm | Intervention/treatment |
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Experimental: Epilepsy
Patients with dominant temporal lobe epilepsy and bilateral temporal lobe epilepsy
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Device: Medtronic Summit System, Olympus
Electrical brain stimulation with an implantable pulse generator
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Focal epilepsy, including seizures with and without impairment of consciousness, and secondarily generalized seizures:
Exclusion Criteria
Contact: Karla Crockett | 507-538-9140 | crockett.karla@mayo.edu |
United States, Minnesota | |
Mayo Clinic in Rochester | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Karla Crockett 507-538-9140 crockett.karla@mayo.edu |
Principal Investigator: | Gregory A Worrell | Mayo Clinic |
Tracking Information | |||||||
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First Submitted Date ICMJE | April 19, 2019 | ||||||
First Posted Date ICMJE | May 10, 2019 | ||||||
Last Update Posted Date | January 6, 2021 | ||||||
Actual Study Start Date ICMJE | July 10, 2019 | ||||||
Estimated Primary Completion Date | April 30, 2022 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Neurophysiologically Based Brain State Tracking and Modulation in Focal Epilepsy | ||||||
Official Title ICMJE | Human Safety and Feasibility Study of Neurophysiologically Based Brain State Tracking and Modulation in Focal Epilepsy | ||||||
Brief Summary | Researchers are trying to determine if tracking seizure occurrence, seizure probability, behavioral state, cognition, and mood can be achieved using an implantable brain sensing and stimulation device (Medtronic RC+S Summit) coupled to an external, handheld, patient assistant device (PAD) with capability for patient interaction (patient data input). The system (RC+S & PAD) provides intracranial EEG (iEEG) sensing, electrical brain stimulation, and machine learning algorithms running on the RC+S and PAD that will be coupled with electrical brain stimulation (EBS) to prevent seizures and improve quality of life in patients with epilepsy. | ||||||
Detailed Description | This study will include patients with dominant temporal lobe epilepsy and bilateral temporal lobe epilepsy. The plan is to have 10 patients take part in this study at Mayo Clinic Rochester. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Epilepsy Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Epilepsy | ||||||
Intervention ICMJE | Device: Medtronic Summit System, Olympus
Electrical brain stimulation with an implantable pulse generator
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Study Arms ICMJE | Experimental: Epilepsy
Patients with dominant temporal lobe epilepsy and bilateral temporal lobe epilepsy
Intervention: Device: Medtronic Summit System, Olympus
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
10 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | December 31, 2022 | ||||||
Estimated Primary Completion Date | April 30, 2022 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria
Exclusion Criteria
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03946618 | ||||||
Other Study ID Numbers ICMJE | 18-005483 UH2NS095495-03 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Gregory Worrell, Mayo Clinic | ||||||
Study Sponsor ICMJE | Mayo Clinic | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Mayo Clinic | ||||||
Verification Date | January 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |