Optimizing Brain Stimulation Parameters

Mayo Clinic

Status: Enrolling

Conditions: Epilepsy; Seizure

Treatments: Device: Stimulation Set A and B

Study type: Interventional

Funder types: Other

Identifiers

NCT06617845

20-009654

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

Stimulation set A/B group

Experimental group

Description:

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).

Treatment:

Device: Stimulation Set A and B

Stimulation set B/A group

Experimental group

Description:

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).

Treatment:

Device: Stimulation Set A and B