An interventional study of Stimulation Set A and B in Epilepsy; Seizure, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2025-10-14.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment
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.
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's planned enrollment of 30 is below the median of 50 across 1,206 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
Seizure burden
Using the Mayo Epilepsy Short Assessment as well as patient diaries, seizure frequency is determined.
Time frame: Baseline, 4 months, 7 months, 12 months
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.
Time frame: 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).
Time frame: Baseline, 4 months, 7 months, 12 months
Plan to share: No
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