Deep Brain Stimulation, Refractory Epilepsy
Conditions
Keywords
Refractory Epilepsy, deep brain stimulation
Brief summary
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.
Interventions
OTHERPS and OS stimulation order 1
PS, OS, OS
OTHERPS and OS stimulation order 2
OS, PS, OS
OTHERPS and OS stimulation order 3
OS, OS, PS
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* medically refractory epilepsy * already have a deep brain stimulator in place
Exclusion criteria
* severe dementia at investigator discretion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in broadband power with different settings | One year from baseline | 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. |
| Difference in frequency band-specific low-frequency power (LFP) with different settings | One year from baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identify all seizures | one year from baseline | Detecting generalized tonic-clonic seizures using a wearable sensor wristband and patients-reported seizure activity. |
| Scores on Montreal Cognitive Assessment, MoCA | one year from baseline | This is a brief cognitive assessment used to look at side effects of stimulation settings |
| Scores on epilepsy-specific quality of life questionnaire (QOLIE-10P) | One year from baseline | This is a brief cognitive assessment used to look at side effects of stimulation settings |
Countries
United States
Contacts
Primary ContactAlec Jonason
Outcome results
None listed