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NCT Number: NCT05493722

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

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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Key information

Conditions

Refractory Epilepsy Brain Diseases Central Nervous System Diseases Deep Brain Stimulation Drug Resistant Epilepsy Epilepsy Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

Location contact

Alec Jonason

CONTACT

[email protected]

612-624-3127

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • severe dementia at investigator discretion

Treatment and study plan

PS and OS stimulation order 1

Other

PS, OS, OS

PS and OS stimulation order 2

Other

OS, PS, OS

PS and OS stimulation order 3

Other

OS, OS, PS

Primary outcomes

  1. Difference in broadband power with different settings

    Time frame: 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.

  2. Difference in frequency band-specific low-frequency power (LFP) with different settings

    Time frame: 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 outcomes

  1. Identify all seizures

    Time frame: one year from baseline

    Detecting generalized tonic-clonic seizures using a wearable sensor wristband and patients-reported seizure activity.

  2. Scores on Montreal Cognitive Assessment, MoCA

    Time frame: one year from baseline

    This is a brief cognitive assessment used to look at side effects of stimulation settings

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

    Time frame: One year from baseline

    This is a brief cognitive assessment used to look at side effects of stimulation settings

Study contacts

Contact information is provided by the study sponsor or research team.

Alec Jonason

CONTACT

[email protected]

612-624-3127

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2023
Primary completion
2028
Study completion
2030
First posted
Aug 9, 2022
Registry last updated
Oct 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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