Optimizing Brain Stimulation Parameters

NCT ID: NCT06617845

Last Updated: 2025-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-20

Study Completion Date

2028-09-01

Brief Summary

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A primary purpose of this study is to better understand what stimulation parameters work best for patients. For example, for Deep Brain Stimulation (DBS) of the Anterior Nucleus of the Thalamus (ANT), it is not clear what stimulation frequency leads is most effective. This study will help assess the effectiveness of low frequency or high frequency stimulation.

Detailed Description

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Conditions

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Epilepsy; Seizure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stimulation set A/B group

Device will be set to use stimulation parameters from set A first (e.g. 145 Hz) and then from set B (e.g. low frequency stimulation).

Group Type EXPERIMENTAL

Stimulation Set A and B

Intervention Type DEVICE

Subjects will receive one stimulation parameter set first for 3 months and then the other for three months. Sets will include Set A (145 Hz high frequency stimulation) and Set B (Low frequency stimulation less than 40 Hz, which is similar to stimulation frequencies used during cortical stimulation). The 145 Hz stimulation will be set to cycling (1 min on, 5 min off) while the low frequency setting will be continuous. Both sets include stimulation parameter sets that have been used in clinical practice as a part of standard of care. However, it is unclear which set is better or whether they are similarly effective.

Stimulation set B/A group

Device will be set to use stimulation parameters from set B first (e.g. low frequency stimulation) and then from set A (e.g. 145 Hz).

Group Type EXPERIMENTAL

Stimulation Set A and B

Intervention Type DEVICE

Subjects will receive one stimulation parameter set first for 3 months and then the other for three months. Sets will include Set A (145 Hz high frequency stimulation) and Set B (Low frequency stimulation less than 40 Hz, which is similar to stimulation frequencies used during cortical stimulation). The 145 Hz stimulation will be set to cycling (1 min on, 5 min off) while the low frequency setting will be continuous. Both sets include stimulation parameter sets that have been used in clinical practice as a part of standard of care. However, it is unclear which set is better or whether they are similarly effective.

Interventions

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Stimulation Set A and B

Subjects will receive one stimulation parameter set first for 3 months and then the other for three months. Sets will include Set A (145 Hz high frequency stimulation) and Set B (Low frequency stimulation less than 40 Hz, which is similar to stimulation frequencies used during cortical stimulation). The 145 Hz stimulation will be set to cycling (1 min on, 5 min off) while the low frequency setting will be continuous. Both sets include stimulation parameter sets that have been used in clinical practice as a part of standard of care. However, it is unclear which set is better or whether they are similarly effective.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients who are implanted with a brain stimulation device targeting the anterior nucleus of the thalamus per Mayo Clinic standard of care

Exclusion Criteria

* Patients for whom clinical follow-up is not expected during the initial 6-8 months following implant
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Brian N. Lundstrom

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mayo Clinic Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Amy Headlee

Role: CONTACT

507-538-4107

Karla Crockett

Role: CONTACT

507-538-4880

Related Links

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http://pubmed.ncbi.nlm.nih.gov/40423665/

Optimizing stimulation parameters for anterior thalamic nuclei deep brain stimulation in epilepsy: A randomized crossover trial

Other Identifiers

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20-009654

Identifier Type: -

Identifier Source: org_study_id

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