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Deep brain stimulation (DBS) is used to treat epilepsy in cases where patients are medically refractory and are not candidates for surgical resection. This therapy has been shown to be effective in seizure reduction, yet very few patients achieve the ultimate goal of seizure freedom. Implantable neural stimulators (INSs) have many parameters that may be adjusted, and could be tuned to achieve very patient specific therapies. This study will develop a platform for stimulation setting optimization based on power spectral density (PSD) measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stimulation Group A | Experimental | Participants with already implanted DBS will receive stimulation order 1. PS, OS, OS. |
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| Stimulation Group B | Experimental | Participants with already implanted DBS will receive stimulation order 1. OS, PS, OS. |
|
| Stimulation Group C | Experimental | Participants with already implanted DBS will receive stimulation order 1. OS, OS, PS. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PS and OS stimulation order 1 | Other | PS, OS, OS |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in broadband power with different settings | Different settings include different combinations of stimulation amplitude, frequency and pulse width. The full spectrum PSD data from all of the in-clinic recordings at all of the unique settings will be combined to look at the resulting difference in broadband power. | One year from baseline |
| Difference in frequency band-specific low-frequency power (LFP) with different settings | Different settings include different combinations of stimulation amplitude, frequency and pulse width. The full spectrum PSD data from all of the in-clinic recordings at all of the unique settings will be combined to look at the resulting difference in frequency band-specific LFP. | One year from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Identify all seizures | Detecting generalized tonic-clonic seizures using a wearable sensor wristband and patients-reported seizure activity. | one year from baseline |
| Scores on Montreal Cognitive Assessment, MoCA |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alec Jonason | Contact | 612-624-3127 | jonas074@umn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Robert McGovern, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55455 | United States |
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Participants will be randomly assigned to a stimulation order at the baseline visit with optimized settings (OS) stimulation occurring for a total of 8 months and physician-selected settings (PS) stimulation chosen for a total of 4 months. For example, a patient may undergo PS setting stimulation from 4-8 months, then undergo OS setting stimulation from 8-12 and 12-16 months. Thus, there are three possible stimulation groups (1. PS, OS, OS; 2.OS, PS, OS; 3. OS, OS, PS).
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A study coordinator who is blinded to the chosen stimulation setting will check the data daily to ensure the patient is wearing the device properly and recording seizure events. At each optimization visit, the MoCA and QOLIE-10P surveys will also be administered to the participants by a member of the research team who is blinded to the group the participant is assigned to.
| PS and OS stimulation order 2 |
| Other |
OS, PS, OS |
|
| PS and OS stimulation order 3 | Other | OS, OS, PS |
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This is a brief cognitive assessment used to look at side effects of stimulation settings
| one year from baseline |
| Scores on epilepsy-specific quality of life questionnaire (QOLIE-10P) | This is a brief cognitive assessment used to look at side effects of stimulation settings | One year from baseline |
| ID | Term |
|---|---|
| D000069279 | Drug Resistant Epilepsy |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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