Optimizing Brain Stimulation Parameters

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.

Study Overview

• Status: Recruiting
• Conditions: Epilepsy; Seizure
• Intervention / Treatment: Device: Stimulation Set A and B

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karla Crockett; Phone Number: 507-538-4880; Email: crockett.karla@mayo.edu
• Study Contact Backup: Name: Amy Headlee; Phone Number: 507-538-4107; Email: Headlee.Amy@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Device: 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.
Experimental: 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).	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mayo Post-Stimulation Activation score	The Mayo Post-Stimulation Activation questionnaire is a 9-item survey measuring post-stimulation symptoms such as speech problems, numbness, muscle tightness, balance, lightheadedness, vision, mood changes, and memory. The questionnaire is ranked on a Likert scale of 1 - Mild; 2 - Moderate; 3 - Severe; 4 - N/A. The minimum value is 1 and the maximum value is 4, where 1 represents less severe.	Baseline, 4 months, 7 months, 12 months
Change in Mayo Epilepsy Short Assessment (MESA) score	The Mayo Epilepsy Short Assessment (MESA) is a questionnaire measuring seizure frequency, seizure severity, quality of life, sleep, and mood. Seizure frequency is measured by number of seizures per month. Severity, life satisfaction, and sleep quality are measured from 1 (worst) to 10 (best). Mood and anxiety are measured on a 4-point scale with the following options (Not at all, Several days, More than half the days, Nearly every day).	Baseline, 4 months, 7 months, 12 months

Collaborators and Investigators

• Sponsor: Mayo Clinic

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2020
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: September 25, 2024
• First Submitted That Met QC Criteria: September 27, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Estimated): October 14, 2025
• Last Update Submitted That Met QC Criteria: October 10, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: 20-009654

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No