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Optimizing Brain Stimulation Parameters

NCT06617845 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-10-14

No results posted yet for this study

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.

Conditions

  • Epilepsy; Seizure

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 practice as a part of standard of care. However, it is unclear which set is better or whether they are similarly effective.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-20
Primary Completion
2027-09-01
Completion
2028-09-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06617845 on ClinicalTrials.gov