Recruiting NCT06617845
Optimizing Brain Stimulation Parameters
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Stimulation Set A and B.
- Who it may be relevant to
- Registry conditions: Epilepsy; Seizure. Basic parameters: from 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- 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 pr
Primary outcome measures
- Seizure burden [Time frame: Baseline, 4 months, 7 months, 12 months]
Secondary outcome measures (2)
- Change in Mayo Post-Stimulation Activation score [Time frame: Baseline, 4 months, 7 months, 12 months]
- Change in Mayo Epilepsy Short Assessment (MESA) score [Time frame: Baseline, 4 months, 7 months, 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mayo Clinic Rochester — Rochester
Identifiers
NCT: NCT06617845 · 20-009654