Optimization of Deep Brain Stimulation Parameters in Patients With Medically Refractory Epilepsy

Deep Brain Stimulation Clinical Trial

Official title:

Optimization of Deep Brain Stimulation Parameters in Patients With Medically Refractory Epilepsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05493722
• Other study ID #: NEUROSURG-2021-29636
• Status: Recruiting
• Phase: Early Phase 1
• Start date: September 15, 2023
• Est. completion date: January 15, 2030

Study information

• Verified date: October 2023
• Source: University of Minnesota
• Contact: Alec Jonason
• Phone: 612-624-3127
• Email: jonas074[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 15, 2030
• Est. primary completion date: January 15, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• medically refractory epilepsy
• already have a deep brain stimulator in place

Exclusion Criteria:

• severe dementia at investigator discretion

Related Conditions & MeSH terms

• Deep Brain Stimulation
• Drug Resistant Epilepsy
• Epilepsy
• Refractory Epilepsy

Intervention

Other:
• PS and OS stimulation order 1
PS, OS, OS
• PS and OS stimulation order 2
OS, PS, OS
• PS and OS stimulation order 3
OS, OS, PS

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	Identify all seizures	Detecting generalized tonic-clonic seizures using a wearable sensor wristband and patients-reported seizure activity.	one year from baseline
Secondary	Scores on Montreal Cognitive Assessment, MoCA	This is a brief cognitive assessment used to look at side effects of stimulation settings	one year from baseline
Secondary	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