Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2020-10-20
2028-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Stimulation set A/B group
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).
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.
Stimulation set B/A group
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).
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
6 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Brian N. Lundstrom
Principal Investigator
Locations
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Mayo Clinic Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Related Links
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Optimizing stimulation parameters for anterior thalamic nuclei deep brain stimulation in epilepsy: A randomized crossover trial
Other Identifiers
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20-009654
Identifier Type: -
Identifier Source: org_study_id
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