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Subthalamic Steering for Therapy Optimization in Parkinson's Disease

NCT03548506 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-09-29

No results posted yet for this study

Summary

Twenty patients with idiopathic Parkinson's disease (PD) will be included into this single center randomized controlled double-blind clinical trial (RCT) in a cross-over design. The treatment consists of two different stimulation settings using (i) conventional omnidirectional stimulation of the subthalamic nucleus \[STN\_O\] as active comparator and (ii) directional steering of STN stimulation via a segmented electrode contact \[STN\_D\].

Conditions

  • Parkinson Disease

Interventions

DEVICE

Omnidirectional Deep Brain Stimulation of STN

Deep Brain Stimulation

DEVICE

Directional Deep Brain Stimulation of STN

Deep Brain Stimulation

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • University Hospital Tuebingen

    lead OTHER

Principal Investigators

  • Alireza Gharabaghi, MD · Division of Functional and Restorative Neurosurgery, Department of Neurosurgery, Tuebingen, Germany

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2018-04-19
Primary Completion
2021-12-31
Completion
2022-04-30
FDA Device
Yes

Countries

  • Germany

Study Locations

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Entities

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 NCT03548506 on ClinicalTrials.gov