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

NCT05493722 | Recruiting Early Phase 1

• 1 other identifier: NEUROSURG-2021-29636
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractory Epilepsy; Deep Brain Stimulation

Keywords

Refractory Epilepsy; deep brain stimulation

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Identify all seizures

  one year from baseline

• Scores on Montreal Cognitive Assessment, MoCA

  one year from baseline

• Scores on epilepsy-specific quality of life questionnaire (QOLIE-10P)

  One year from baseline

Study Arms (3)

Stimulation Group A

EXPERIMENTAL

Participants with already implanted DBS will receive stimulation order 1. PS, OS, OS.

Other: PS and OS stimulation order 1

Stimulation Group B

EXPERIMENTAL

Participants with already implanted DBS will receive stimulation order 1. OS, PS, OS.

Other: PS and OS stimulation order 2

Stimulation Group C

EXPERIMENTAL

Participants with already implanted DBS will receive stimulation order 1. OS, OS, PS.

Other: PS and OS stimulation order 3

Interventions

PS and OS stimulation order 1 OTHER

PS, OS, OS

Stimulation Group A

PS and OS stimulation order 2 OTHER

OS, PS, OS

Stimulation Group B

PS and OS stimulation order 3 OTHER

OS, OS, PS

Stimulation Group C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• severe dementia at investigator discretion

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Robert McGovern, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alec Jonason

CONTACT

612-624-3127; jonas074@umn.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 9, 2022
• Study Start: September 15, 2023
• Primary Completion (Estimated): January 15, 2028
• Study Completion (Estimated): January 15, 2030
• Last Updated: October 24, 2025

Record last verified: 2025-10

Locations

US (1)