Chronically-recorded Deep Brain Nuclei/Hippocampal High Frequency Oscillations (HFOs) as Biomarkers of Neurologic Disease.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Parkinson
- Sponsor
- Mayo Clinic
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Degree of correlation of recorded neural signatures with disease severity as determined by regression analysis
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This study is designed to evaluate the high-frequency range deep brain oscillations (HFO) as pathologic markers in patients undergoing deep brain stimulation for epilepsy or Parkinson disease. Newly developed technology allows for the chronic recording of these brain signals at the same time as clinical stimulation is occuring. We will learn both whether these HFO correlate with disease activity and whether the HFO change in response to ongoing stimulation (potentially giving insight into the underlying mechanism of action of DBS).
Detailed Description
This study is designed to evaluate the high-frequency range deep brain oscillations (HFO) as pathologic markers in patients undergoing deep brain stimulation for epilepsy or Parkinson disease. Newly developed technology allows for the chronic recording of these brain signals at the same time as clinical stimulation is occuring. We will learn both whether these HFO correlate with disease activity and whether the HFO change in response to ongoing stimulation (potentially giving insight into the underlying mechanism of action of DBS). Study participants will undergo DBS in the same way as is usually done but will receive this newer battery with ability to record brain signals.
Investigators
Bryan T. Klassen, M.D.
Consultant Neurology
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Degree of correlation of recorded neural signatures with disease severity as determined by regression analysis
Time Frame: 26 weeks post deep brain stimulator implantation
Regression analysis will be performed using the measures of clinical disease severity as the independent variables and the various HFO measurement conditions/parameters as dependent variables. HFO parameters to be analyzed will include: 1) total power within each recorded band and 2) frequency distribution as defined by the ratio of power within the higher HFO frequency band versus the lower HFO frequency band. Clinical disease severity will be determined by: 1) Unified Parkinson's Disease Rating Scale (UPDRS III) score in each of the various conditions for Parkinson Disease (PD) subjects, 2) motor diaries linked with each visit for PD subjects, and 3) seizure counts from the 4 weeks of seizure diary preceding each visit for epilepsy subjects. (Note: UPDRS is a rating scale used to follow the longitudinal course of Parkinson's disease. Part III is a clinician-scored monitored motor evaluation.)