An interventional study of [standard STN] and [STN+SNr] in Parkinson's Disease and Dysphagia, sponsored by University Hospital Tuebingen. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-05-30.
Sponsored by University Hospital Tuebingen · Not applicable, Interventional, and Treatment
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Among 10 studies in Parkinson Disease by University Hospital Tuebingen — 3 open to participants now, 3 under way, 1 of them phase 3. Parkinson Disease · University Hospital Tuebingen.
Among the 10 studies in Parkinson Disease by University Hospital Tuebingen, this one is one of 3 that started in 2018, is one of 4 with no phase, and was the 3rd registered.
4,576 studies on the registry are indexed under Parkinson Disease; 1,087 are open to participants now.
Browse Parkinson Disease studies →3 of the 10 studies in Parkinson Disease by University Hospital Tuebingen are open now, in 7 countries. Recruiting first, the newest first:
University Hospital Tuebingen · Sites in France, Germany, Italy and 4 more countries
Ages 35–80
University Hospital Tuebingen · Sites in Germany
Ages 18–75
University Hospital Tuebingen · Sites in Germany
Ages 51–80
By country, each count listing its studies:
Of the 749 Parkinson Disease studies recruiting now, 311 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 64 take children under 18; 189 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
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10 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 3 started in 2018.
This study's planned enrollment of 20 is below the median of 40 across 3,355 interventional studies indexed under Parkinson Disease.
Median enrollment 42 across the 7 interventional studies, 130 across the 3 observational. Of the 3 that completed or were terminated, 0 (0%) have results posted.
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University Hospital Tuebingen is the lead sponsor of 491 studies on the registry; 109 are open to participants now.
1 of the studies in Parkinson Disease by University Hospital Tuebingen that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07411365University Hospital TuebingenDual-task Cognitive-motor Telerehabilitation in Persons With PD-MCI | 2027-08-31 |
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Among the 10 studies in Parkinson Disease by University Hospital Tuebingen, from their registry updates:
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
standard stimulation on subthalamic (STN) contacts plus swallowing therapy
Device: [standard STN] · Behavioral: Swallowing therapy
Combined stimulation of the subthalamic nucleus (STN) and the substantia nigra pars reticulata (SNr) plus swallowing therapy
Device: [STN+SNr] · Behavioral: Swallowing therapy
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
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
Swallowing therapy with speech therapist
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
Time frame: Outcome after eight weeks (V2) with reference to baseline (V1)
MDS-UPDRS parts I, II, III and IV
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.
Time frame: Outcome after eight weeks (V2) with reference to baseline (V1)
Capsit-PD
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.
Time frame: Outcome after eight weeks (V2) with reference to baseline (V1)
Freezing of Gait Assessment Course (FOG-AC)
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)
Time frame: Outcome after eight weeks (V2) with reference to baseline (V1)
PDQ-39
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.
Time frame: Outcome after eight weeks (V2) with reference to baseline (V1)
Dysphagia-related Quality of Life (SWAL-QoL)
48-item quality-of-life outcomes tool for dysphagia researchers and clinicians
Time frame: Outcome after eight weeks (V2) with reference to baseline (V1)
Clinical global impression self
(self-reporting, caregiver-reporting)
Time frame: Outcome after eight weeks (V2)
Diary on swallowing an related complications
complications (cough, suffocation, bronchitis, aspiration pneumonia)
Time frame: Outcome after eight weeks (V2) with reference to baseline (V1)
Site of Swallow reflex initiation
Two FEES outcome variables-delayed initiation of the pharyngeal reflex and postswallow pyriform sinus pooling(Scott et al 1998)
Time frame: Outcome after eight weeks (V2) with reference to baseline (V1)
Test of Mastication and Swallowing solids (TOMASS)
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.
Time frame: Outcome after eight weeks (V2) with reference to baseline (V1)
Pharyngeal Residue Visual Analogue Scale (VAS)
With FEES the pharyngeal residue (Sinus piriformis and vallecular) are rated on a visual analogue scale
Time frame: Outcome after eight weeks (V2) with reference to baseline (V1)
Functional oral intake scale (FOIS)
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)
Time frame: Outcome after eight weeks (V2) with reference to baseline (V1)
Started Apr 2018 (actual). Primary completion is estimated for May 2020, 24 months after the start.
Of 1,293 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 24 months is close to that.
Counting every sponsor, half of 1,369 studies reached it within 25 months; a quarter within 12 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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