Data-Driven Characterization of Neuronal Markers During Deep Brain Stimulation for Patients With Parkinson's Disease

NCT03079960 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-07-28

No results posted yet for this study

Summary

Deep brain stimulation (DBS) of the subthalamic nucleus (STN) has developed into a standard therapy in the refractory stage of Parkinson's disease (PD). Implanted micro- and macroelectrodes can be used to derive neural signals from the basal ganglia (BG). Cortical signals can be obtained by measurements of the electroencephalogram (EEG) or the electrocorticogram (ECoG). Both signal types can be used to characterize the motor system of the patient and make it possible to estimate the effectiveness of a currently performed DBS. However, the relationship between such neuronal features on the one hand and the DBS stimulation parameters or the observable clinical effects on the other hand is very individual and varies from patient to patient.

The aim of the present study is to: (1) determine neuronal characteristics that are informative about the clinically relevant motor status of PD patients. (2) The investigation and description of the complex non-stationary dynamics of neuronal characteristics as a consequence of changing DBS stimulation parameters. (3) The study of the effect of changing DBS stimulation parameters on motor performance.

The three objectives form an important building block for future adaptive closed-loop DBS strategies (aDBS). Here, the stimulation parameters are to be adapted in the single-trial and depending on the currently detected motor state of the patient. Since this is accessible only to a very limited extent, it is to be investigated whether information about the motor state can be obtained from the neural features.

Conditions

  • Parkinson Disease

Interventions

DEVICE

Electrophysiological recording and measurement devices

Externalization of DBS connectors and macroelectrodes for simultaneous STN stimulation LFP recordings by the use of electrophysiological recording and measurement devices.

Sponsors & Collaborators

  • University of Freiburg

    collaborator OTHER
  • Prof. Dr. Volker Arnd Coenen

    lead OTHER

Principal Investigators

  • Volker Coenen, Prof. Dr. · University Hospital Freiburg

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-04
Primary Completion
2021-12-30
Completion
2021-12-30

Countries

  • Germany

Study Locations

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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 NCT03079960 on ClinicalTrials.gov