Combined Stimulation of STN and SNr for Dysphagia in Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT03470324|
Recruitment Status : Recruiting
First Posted : March 19, 2018
Last Update Posted : May 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease Dysphagia||Device: [standard STN] Device: [STN+SNr] Behavioral: Swallowing therapy||Not Applicable|
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. The Trial is designed as superiority study with an 81% power to detect a clinically relevant mean improvement of 2 points on the Penetration Aspiration Scale for fluids (two-tailed p < 0.05). To this end 20 patients will be randomized. After a common baseline assessment in [standardSTN], patients will be randomized to either [standardSTN] or [STN+SNr] in 1:1 ratio (10 per arm). The primary endpoint assessment is scheduled 8 weeks from baseline assessment (V2). Both treatment arms will receive swallowing therapy as standard of care.
The rationale for this study comes from the association of swallowing and oral transport to neuronal integration upon the substantial nigra pars reticulate (SNr)-superior colliculus (SC) pathway (Rossi et al., 2016). Deep brain stimulation of the SNr has been put forward to modulate brainstem circuitry through its monosynaptic brainstem projections to the SC and to the pedunculopontine nucleus (PPN) (Chastan et al., 2009, Weiss et al., 2013, Rossi et al., 2016).
Secondary outcome measures include anamnestic assessments on dysphagia, clinical global impression, freezing of gait and falls, balance, quality of life, neuropsychiatric symptoms and suicidality. Secondary outcome measures also include clinical assessment of dysphagia (Site of Swallow Reflex Initiation, Test of Mastication and Swallowing solids, pharyngeal residue) as well as motor symptoms with MDS-UPDRS III, Capsit-PD and Freezing of Gait Assessment Course.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Combined Stimulation of Subthalamic Nucleus and Substantia Nigra Pars Reticulata for Dysphagia: A Randomized Controlled Multicenter Trial|
|Actual Study Start Date :||April 27, 2018|
|Estimated Primary Completion Date :||May 1, 2020|
|Estimated Study Completion Date :||July 1, 2020|
Active Comparator: [standard STN] + swallowing therapy
standard stimulation on subthalamic (STN) contacts plus swallowing therapy
Device: [standard STN]
standard stimulation on subthalamic (STN) contacts High frequency deep brain stimulation with variable (best individual) stimulation on subthalamic contacts
Other Name: subthalamic deep brain stimulation
Behavioral: Swallowing therapy
Swallowing therapy with speech therapist
Experimental: [STN+SNr] + swallowing therapy
Combined stimulation of the subthalamic nucleus (STN) and the substantia nigra pars reticulata (SNr) plus swallowing therapy
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
Other Name: combined subthalamic and nigral stimulation
Behavioral: Swallowing therapy
Swallowing therapy with speech therapist
- Penetration Aspiration Scale [ Time Frame: Outcome after eight weeks (V2) with reference to baseline (V1) ]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
- MDS-UPDRS parts I, II, III and IV [ Time Frame: Outcome after eight weeks (V2) with reference to baseline (V1) ]Rating Scale for symptoms of Parkinson's Disease: I Non-motor Experiences of Daily Living; II: Motor Experiences of Daily Living; III: Motor Examination; IV: Motor Complications.
- Capsit-PD [ Time Frame: Outcome after eight weeks (V2) with reference to baseline (V1) ]Walking distance of 7m. Patient has to walk that distance back and forth. The time is measured as well as the number of steps needed for each way. Also, freezing episodes are counted.
- Freezing of Gait Assessment Course (FOG-AC) [ Time Frame: Outcome after eight weeks (V2) with reference to baseline (V1) ]
Patients were asked to sit down on a chair, then stand up and walk to a floor mark .Within the mark they performed two 360° turns, clockwise (cw) and counter-clockwise (ccw). Then: open and walk through the door, turn outside, and come back to their chair.
Four situations were rated: The start to walk, the turning (cw and ccw), and the passing through the door. 0 points: no festination and no FOG , 1 point: festination or any hastening steps. 2 points: FOG (trembling-in-place or total akinesia), which the patient could overcome himself. 3points: abortion of the task or need of interference by the examiner. Three levels of multiple tasking were applied: First passage;: no additional task ("walking"). Second passage: carrying a tray with a plastic cup full of water. Third passage: motor task and a mental task ("carrying and calculation"). (Ziegler et al. 2010)
- PDQ-39 [ Time Frame: Outcome after eight weeks (V2) with reference to baseline (V1) ]The 39-item Parkinson's Disease Questionnaire is a widely used patient-reported clinical trial endpoint, where patients are asked about their health-related quality of life related to Parkinson's disease.
- Dysphagia-related Quality of Life (SWAL-QoL) [ Time Frame: Outcome after eight weeks (V2) with reference to baseline (V1) ]48-item quality-of-life outcomes tool for dysphagia researchers and clinicians
- Clinical global impression self [ Time Frame: Outcome after eight weeks (V2) ](self-reporting, caregiver-reporting)
- Diary on swallowing an related complications [ Time Frame: Outcome after eight weeks (V2) with reference to baseline (V1) ]complications (cough, suffocation, bronchitis, aspiration pneumonia)
- Site of Swallow reflex initiation [ Time Frame: Outcome after eight weeks (V2) with reference to baseline (V1) ]Two FEES outcome variables—delayed initiation of the pharyngeal reflex and postswallow pyriform sinus pooling(Scott et al 1998)
- Test of Mastication and Swallowing solids (TOMASS) [ Time Frame: Outcome after eight weeks (V2) with reference to baseline (V1) ]The Test of Masticating and Swallowing Solids (TOMASS) was developed as a quantitative assessment of solid bolus ingestion. For each study the test required participants to ingest a commercially available cracker with instructions to 'eat this as quickly as is comfortably possible'. Further averaged measures were derived including the number of masticatory cycles and swallows per bite, and time per bite, masticatory cycle and swallow.
- Pharyngeal Residue Visual Analogue Scale (VAS) [ Time Frame: Outcome after eight weeks (V2) with reference to baseline (V1) ]With FEES the pharyngeal residue (Sinus piriformis and vallecular) are rated on a visual analogue scale
- Functional oral intake scale (FOIS) [ Time Frame: Outcome after eight weeks (V2) with reference to baseline (V1) ]Scale to assess oral intake (7 points indicate full oral intake without restrictions, 1 points indicates no oral intake possible, 1-3 tube dependent) (Crary et al. 2005)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03470324
|Contact: Daniel Weiss, MDemail@example.com|
|Contact: Alireza Gharabaghi, MDfirstname.lastname@example.org|
|University of Tübingen||Recruiting|
|Tübingen, Germany, 72076|
|Contact: Daniel Weiss, MD 49 7071 29 82340 email@example.com|
|Principal Investigator:||Daniel Weiss, MD||University Hospital Tuebingen|