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NCT Number: NCT06617845

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.

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Key information

Conditions

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

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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.

Primary outcomes

  1. Seizure burden

    Time frame: Baseline, 4 months, 7 months, 12 months

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

Secondary outcomes

  1. Change in Mayo Post-Stimulation Activation score

    Time frame: Baseline, 4 months, 7 months, 12 months

    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.

  2. Change in Mayo Epilepsy Short Assessment (MESA) score

    Time frame: Baseline, 4 months, 7 months, 12 months

    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).

Study contacts

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

Amy Headlee

CONTACT

[email protected]

507-538-4107

Karla Crockett

CONTACT

[email protected]

507-538-4880

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2020
Primary completion
2027
Study completion
2028
First posted
Oct 1, 2024
Registry last updated
Oct 14, 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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