Status:
UNKNOWN
Combined Stimulation of STN and SNr for Dysphagia in Parkinson's Disease
Lead Sponsor:
University Hospital Tuebingen
Collaborating Sponsors:
Michael J. Fox Foundation for Parkinson's Research
Conditions:
Parkinson's Disease
Dysphagia
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 sti...
Detailed Description
The primary endpoint of this study is to investigate the efficacy and safety of combined \[STN+SNr\] stimulation by "interleaving stimulation" as compared to \[standardSTN\] after 8 weeks on dysphagia...
Eligibility Criteria
Inclusion
- cognitive competence to consent
- Idiopathic Parkinson's disease (according to the "British Brain Bank criteria" (Hughes, 1992) including genetic forms
- Therapy with STN-DBS (deep brain stimulation) (ACTIVA pulse generators) at least six months from surgery
- Activa PC (Primary Cell) or Activa RC (Rechargeable Cell) as implanted pulse generator with "Interleaving" programming option
- Localization of an active electrode contact in the sub thalamic nucleus
- Localization of the caudal electrode contacts in the substantia nigra pars reticulata area (coordinates relative to midcommisural Point (MCP): left: -7mm ≤ x ≤ -12mm; -2mm ≤ y ≤ -6mm; -6mm ≤ z ≤ -10mm right: 7mm ≤ x ≤ 12mm; -2mm ≤ y ≤ -6mm; -6mm ≤ z ≤ -10mm (x = medio-lateral, y = anterio-posterior, z = rostro-caudal)
- ≥ 30% improvement in UPDRS III with 'standard STN' compared to 'stimulation off' in dopaminergic off
- Penetration-Aspiration-Scale ≥ 3 or more than 20% utilization of vallecular space and/or pyriform sinuses post swallowing
- Disease duration ≥ 5 years
- Age: between 18 and 80 years
- Dopaminergic medication constant for at least two weeks prior to study enrollment
- Written informed consent
Exclusion
- Participation in other clinical trials within the past three months and during study enrolment
- Cognitive impairment (Mini Mental State Exam \< 20)
- Severe depressive episode with or without psychotic symptoms and suicidality (ICD-10: F32.2, F32.3), psychosis (ICD-10: F23.-)
- Other severe pathological chronic condition that might confound treatment effects or interpretation of the data
- Pregnancy
- Infection and pneumonia at the time of study enrollment
- Other competing cause for dysphagia (e.g. stroke, operation, radiotherapy)
Key Trial Info
Start Date :
April 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03470324
Start Date
April 27 2018
End Date
July 1 2020
Last Update
May 30 2018
Active Locations (1)
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1
University of Tübingen
Tübingen, Germany, 72076