High Frequency Oscillations in Neurologic Disease

Phase 1

Completed

• Conditions: Parkinson; Epilepsy
• Interventions: Device: Activa PC+S

• Registration Number: NCT02235792
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-14
• Study First Submitted QC: 2014-09-05
• Study First Posted: 2014-09-10
• Primary Completion: 2020-11-20
• Study Completion: 2020-11-20
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-14
• Last Update Posted: 2022-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Deep Brain Stimulation 37604 Activa PC+S	Activa PC+S	All subjects will undergo DBS using the 37604 Activa PC+S device (single arm study).

Primary Outcome Measures

Name	Time	Method
Degree of correlation of recorded neural signatures with disease severity as determined by regression analysis	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.)

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States