Optimizing Brain Stimulation Parameters

Not Applicable

Recruiting

• Conditions: Epilepsy; Seizure
• Interventions: Device: Stimulation Set A and B

• Registration Number: NCT06617845
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-20
• Status Verified: 2024-09
• Study First Submitted: 2024-09-25
• Study First Submitted QC: 2024-09-27
• Last Update Submitted: 2024-09-27
• Study First Posted: 2024-09-30
• Last Update Posted: 2024-09-30
• Primary Completion: 2027-09-01
• Study Completion: 2028-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Stimulation set A/B group	Stimulation Set A and B	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).
Stimulation set B/A group	Stimulation Set A and B	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).

Primary Outcome Measures

Name	Time	Method
Seizure burden	Baseline, 4 months, 7 months, 12 months	Using the Mayo Epilepsy Short Assessment as well as patient diaries, seizure frequency is determined.

Secondary Outcome Measures

Name	Time	Method
Change in Mayo Post-Stimulation Activation score	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.
Change in Mayo Epilepsy Short Assessment (MESA) score	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).

Trial Locations

Locations (1)

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States