Optimization of Deep Brain Stimulation Parameters in Patients With Medically Refractory Epilepsy
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Minnesota
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
medically refractory epilepsy
already have a deep brain stimulator in place
Disqualifiers
severe dementia at investigator discretion
Trial design
Design model
Single group
Treatments tested in this trial
PS and OS stimulation order 1
Other interventionPS, OS, OS
PS and OS stimulation order 2
Other interventionOS, PS, OS
PS and OS stimulation order 3
Other interventionOS, OS, PS
DBS Setting Optimization
DeviceParticipants with electrodes in a thalamic location other than the anterior nucleus of the thalamus will undergo deep brain stimulation setting optimization but will not be randomized to one of the three stimulation-order groups.
Treatment groups
30 Participants
are divided into 4 treatment groupsGroup A: PS, OS, OS Stimulation SequenceExperimental treatment 1 intervention
Group B: OS, PS, OS Stimulation SequenceExperimental treatment 1 intervention
Group C: OS, OS, PS Stimulation SequenceExperimental treatment 1 intervention
Group D: Non-Anterior Thalamic Electrode LocationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
One year from baseline2
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.
Time frame
One year from baselineSecondary outcomes
1
Identify all seizures
Detecting generalized tonic-clonic seizures using a wearable sensor wristband and patients-reported seizure activity.
Time frame
one year from baseline2
Scores on Montreal Cognitive Assessment, MoCA
This is a brief cognitive assessment used to look at side effects of stimulation settings
Time frame
one year from baseline3
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
Time frame
One year from baselineSponsors and contacts
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Source ClinicalTrials.gov