NCT03470324

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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 19, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

April 27, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

May 30, 2018

Status Verified

May 1, 2018

Enrollment Period

2 years

First QC Date

December 30, 2017

Last Update Submit

May 29, 2018

Conditions

Parkinson's DiseaseDysphagia

Keywords

Parkinson's diseaseDysphagiaParkinsonian DisordersNeurodegenerative DiseasesMovement DisordersNervous System DiseasesBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesDeep brain stimulationsubstantia nigra pars reticulatasubthalamic nucleus

Outcome Measures

Primary Outcomes (1)

  • Penetration Aspiration Scale

    8-point interval scale (range 1 - 8) to describe penetration and aspiration events . Scores are determined primarily by the depth to which material passes in the airway and by whether or not material entering the airway is expelled. (Rosenbek et al, 1996). The score is obtained in swallowing of fluids

    Outcome after eight weeks (V2) with reference to baseline (V1)

Secondary Outcomes (11)

  • MDS-UPDRS parts I, II, III and IV

    Outcome after eight weeks (V2) with reference to baseline (V1)

  • Capsit-PD

    Outcome after eight weeks (V2) with reference to baseline (V1)

  • Freezing of Gait Assessment Course (FOG-AC)

    Outcome after eight weeks (V2) with reference to baseline (V1)

  • PDQ-39

    Outcome after eight weeks (V2) with reference to baseline (V1)

  • Dysphagia-related Quality of Life (SWAL-QoL)

    Outcome after eight weeks (V2) with reference to baseline (V1)

  • +6 more secondary outcomes

Study Arms (2)

[standard STN] + swallowing therapy

ACTIVE COMPARATOR

standard stimulation on subthalamic (STN) contacts plus swallowing therapy

Device: [standard STN]Behavioral: Swallowing therapy

[STN+SNr] + swallowing therapy

EXPERIMENTAL

Combined stimulation of the subthalamic nucleus (STN) and the substantia nigra pars reticulata (SNr) plus swallowing therapy

Device: [STN+SNr]Behavioral: Swallowing therapy

Interventions

[standard STN]DEVICE

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

Also known as: subthalamic deep brain stimulation
[standard STN] + swallowing therapy
[STN+SNr]DEVICE

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

Also known as: combined subthalamic and nigral stimulation
[STN+SNr] + swallowing therapy
Swallowing therapyBEHAVIORAL

Swallowing therapy with speech therapist

[STN+SNr] + swallowing therapy[standard STN] + swallowing therapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tübingen

Tübingen, 72076, Germany

RECRUITING

Related Publications (6)

  • Weiss D, Walach M, Meisner C, Fritz M, Scholten M, Breit S, Plewnia C, Bender B, Gharabaghi A, Wachter T, Kruger R. Nigral stimulation for resistant axial motor impairment in Parkinson's disease? A randomized controlled trial. Brain. 2013 Jul;136(Pt 7):2098-108. doi: 10.1093/brain/awt122. Epub 2013 Jun 11.

    PMID: 23757762BACKGROUND

  • Rossi MA, Li HE, Lu D, Kim IH, Bartholomew RA, Gaidis E, Barter JW, Kim N, Cai MT, Soderling SH, Yin HH. A GABAergic nigrotectal pathway for coordination of drinking behavior. Nat Neurosci. 2016 May;19(5):742-748. doi: 10.1038/nn.4285. Epub 2016 Apr 4.

    PMID: 27043290BACKGROUND

  • Chastan N, Westby GW, Yelnik J, Bardinet E, Do MC, Agid Y, Welter ML. Effects of nigral stimulation on locomotion and postural stability in patients with Parkinson's disease. Brain. 2009 Jan;132(Pt 1):172-84. doi: 10.1093/brain/awn294. Epub 2008 Nov 11.

    PMID: 19001482BACKGROUND

  • Scholten M, Klemt J, Heilbronn M, Plewnia C, Bloem BR, Bunjes F, Kruger R, Gharabaghi A, Weiss D. Effects of Subthalamic and Nigral Stimulation on Gait Kinematics in Parkinson's Disease. Front Neurol. 2017 Oct 17;8:543. doi: 10.3389/fneur.2017.00543. eCollection 2017.

    PMID: 29089922BACKGROUND

  • Hidding U, Gulberti A, Horn A, Buhmann C, Hamel W, Koeppen JA, Westphal M, Engel AK, Gerloff C, Weiss D, Moll CK, Potter-Nerger M. Impact of Combined Subthalamic Nucleus and Substantia Nigra Stimulation on Neuropsychiatric Symptoms in Parkinson's Disease Patients. Parkinsons Dis. 2017;2017:7306192. doi: 10.1155/2017/7306192. Epub 2017 Jan 26.

    PMID: 28246572BACKGROUND

  • Weiss D, Breit S, Wachter T, Plewnia C, Gharabaghi A, Kruger R. Combined stimulation of the substantia nigra pars reticulata and the subthalamic nucleus is effective in hypokinetic gait disturbance in Parkinson's disease. J Neurol. 2011 Jun;258(6):1183-5. doi: 10.1007/s00415-011-5906-3. Epub 2011 Feb 2. No abstract available.

    PMID: 21287187BACKGROUND

MeSH Terms

Conditions

Parkinson DiseaseDeglutition DisordersParkinsonian DisordersNeurodegenerative DiseasesMovement DisordersNervous System DiseasesBasal Ganglia DiseasesBrain DiseasesCentral Nervous System Diseases

Condition Hierarchy (Ancestors)

SynucleinopathiesEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Daniel Weiss, MD

    University Hospital Tuebingen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Weiss, MD

CONTACT

0049-7071-29-82340daniel.weiss@uni-tuebingen.de

Alireza Gharabaghi, MD

CONTACT

0049-7071-29-83550alireza.gharabaghi@uni-tuebingen.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

December 30, 2017

First Posted

March 19, 2018

Study Start

April 27, 2018

Primary Completion

May 1, 2020

Study Completion

July 1, 2020

Last Updated

May 30, 2018

Record last verified: 2018-05

Locations

DE(1)