Optimizing Brain Stimulation Parameters

NCT06617845 | Recruiting FDA Device

• 1 other identifier: 20-009654
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Epilepsy; Seizure

Outcome Measures

Primary Outcomes (1)

• Seizure burden

  Using the Mayo Epilepsy Short Assessment as well as patient diaries, seizure frequency is determined.

  Baseline, 4 months, 7 months, 12 months

Secondary Outcomes (2)

• Change in Mayo Post-Stimulation Activation score

  Baseline, 4 months, 7 months, 12 months

• Change in Mayo Epilepsy Short Assessment (MESA) score

  Baseline, 4 months, 7 months, 12 months

Study Arms (2)

Stimulation set A/B group

EXPERIMENTAL

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).

Device: Stimulation Set A and B

Stimulation set B/A group

EXPERIMENTAL

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).

Device: Stimulation Set A and B

Interventions

Stimulation Set A and B 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 A/B group; Stimulation set B/A group

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients for whom clinical follow-up is not expected during the initial 6-8 months following implant

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

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

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Amy Headlee

CONTACT

507-538-4107; headlee.amy@mayo.edu

Karla Crockett

CONTACT

507-538-4880; crockett.karla@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: October 1, 2024
• Study Start: October 20, 2020
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: October 14, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)