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Combined Stimulation of STN and SNr for Resistant Freezing of Gait in Parkinson's Disease

NCT02588144 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2017-06-20

No results posted yet for this study

Summary

54 patients with idiopathic Parkinson's disease and freezing of gait resistant to subthalamic nucleus stimulation and dopaminergic medication will be included into this multicentre randomised controlled double-blinded parallel group clinical trial. The treatment consists of two different stimulation settings using (i) conventional stimulation of the subthalamic nucleus \[standard STN\] as active comparator and (ii) combined stimulation of active electrode contacts located in both the subthalamic nucleus and substantia nigra pars reticulata \[STN+SNr\].

Conditions

Interventions

PROCEDURE

[standard STN]

High frequency deep brain stimulation with variable (best individual) stimulation on subthalamic contacts

PROCEDURE

[STN+SNr]

high frequency deep brain stimulation of combined (best individual) subthalamic and nigral stimulation

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • University Hospital Tuebingen

    lead OTHER

Principal Investigators

  • Daniel Weiss, MD · Department for Neurodegenerative Diseases, Centre for Neurology, Tübingen, Germany, and Hertie-Institute for Clinical Brain Research

  • Alireza Gharabaghi, MD · Division of Functional and Restorative Neurosurgery, Department of Neurosurgery, Tübingen, Germany, and Center for Integrative Neuroscience, Tübingen, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • Germany
  • Luxembourg

Study Locations

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Entities

Diseases
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 NCT02588144 on ClinicalTrials.gov