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Combined Stimulation of STN and SNr for Dysphagia in Parkinson's Disease

NCT03470324 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-05-30

No results posted yet for this study

Summary

20 patients with idiopathic Parkinson's disease and dysphagia will be included into this 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 \[STN+SNr\]. Both groups receive additional swallowing therapy as standard of care.

Conditions

Interventions

DEVICE

[standard STN]

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

DEVICE

[STN+SNr]

Combined stimulation of the subthalamic nucleus (STN) and the substantia nigra pars reticulata (SNr) high frequency deep brain stimulation of combined (best individual) subthalamic and nigral stimulation

BEHAVIORAL

Swallowing therapy

Swallowing therapy with speech therapist

Sponsors & Collaborators

  • Michael J. Fox Foundation for Parkinson's Research

    collaborator OTHER

  • University Hospital Tuebingen

    lead OTHER

Principal Investigators

  • Daniel Weiss, MD · University Hospital Tuebingen

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
2018-04-27
Primary Completion
2020-05-01
Completion
2020-07-01

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT03470324 on ClinicalTrials.gov