Epilepsy; Seizure
Conditions
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.
Interventions
DEVICEStimulation 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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Contacts
Primary ContactAmy Headlee
Backup ContactKarla Crockett
Outcome results
None listed