Optimizing Brain Stimulation Parameters
ConditionEpilepsy; Seizure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6+
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who are implanted with a brain stimulation device targeting the anterior nucleus of the thalamus per Mayo Clinic standard of care
Disqualifiers
Patients for whom clinical follow-up is not expected during the initial 6-8 months following implant
Trial design
Design model
Crossover
Treatments tested in this trial
Stimulation Set A and B
DeviceSubjects 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Stimulation set A/B groupExperimental treatment 1 intervention
Group B: Stimulation set B/A groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
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 months2
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 monthsSponsors and contacts
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Source ClinicalTrials.gov