Parkinson's DiseaseNCT03470324
Combined Stimulation of STN and SNr for Dysphagia in Parkinson's Disease
A study testing [standard STN], [STN+SNr] and Swallowing therapy in people with Parkinson's Disease and Dysphagia, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson's Disease, Dysphagia
- What is being tested?
- [standard STN], [STN+SNr] and Swallowing therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 27 Apr 2018to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- ≥ 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Tübingen
Tübingen, 72076
Daniel Weiss, MD, 49 7071 29 82340, daniel.weiss@uni-tuebingen.de
About this study
Official title: Combined Stimulation of Subthalamic Nucleus and Substantia Nigra Pars Reticulata for Dysphagia: A Randomized Controlled Multicenter Trial
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.
Read the 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. 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.
- Conditions
- Parkinson's Disease, Dysphagia
- Being tested
- [standard STN], [STN+SNr], Swallowing therapy
- Keywords
- Parkinson's disease, Dysphagia, Parkinsonian Disorders, Neurodegenerative Diseases, Movement Disorders, Nervous System Diseases, Basal Ganglia Diseases, Brain Diseases, Central Nervous System Diseases, Deep brain stimulation, substantia nigra pars reticulata, subthalamic nucleus
- Medical subject headings
- Parkinson Disease, Deglutition Disorders, Parkinsonian Disorders, Neurodegenerative Diseases, Movement Disorders, Nervous System Diseases, Basal Ganglia Diseases, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[standard STN]Device
Also called subthalamic deep brain stimulation
standard stimulation on subthalamic (STN) contacts High frequency deep brain stimulation with variable (best individual) stimulation on subthalamic contacts
[STN+SNr]Device
Also called combined subthalamic and nigral 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
Swallowing therapyBehavioural
Swallowing therapy with speech therapist
| Study group | Role | What they receive |
|---|---|---|
| [standard STN] + swallowing therapy | Active comparator | standard stimulation on subthalamic (STN) contacts plus swallowing therapy Receives: 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 Receives: Device: [STN+SNr]; Behavioral: Swallowing therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Outcome after eight weeks (V2) with reference to baseline (V1)
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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
Measured: Outcome after eight weeks (V2) with reference to baseline (V1)
Clinical global impression self
(self-reporting, caregiver-reporting)
Measured: Outcome after eight weeks (V2)
Diary on swallowing an related complications
complications (cough, suffocation, bronchitis, aspiration pneumonia)
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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)
Measured: Outcome after eight weeks (V2) with reference to baseline (V1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start27 Apr 2018
- Primary completion1 May 2020 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Principal investigator, Daniel Weiss, University Hospital Tuebingen
- Investigators
- Daniel Weiss, MD, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470324
- Sponsor's protocol ID
- 686/2017BO1
- Status last verified
- May 2018
- First submitted
- 30 Dec 2017
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 23757762Rossi 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.
PubMed 27043290Chastan 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.
PubMed 19001482Scholten 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.
PubMed 29089922Hidding 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.
PubMed 28246572Weiss 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.
PubMed 21287187
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Stimulation of Subthalamic Nucleus and Substantia Nigra Pars Reticulata for Dysphagia: A Randomized Controlled Multicenter Trial
- ClinicalTrials.gov ID
- NCT03470324
- Acronym / sponsor ID
- 686/2017BO1
- Conditions
- Parkinson's Disease, Dysphagia
- Keywords
- Parkinson's disease, Dysphagia, Parkinsonian Disorders, Neurodegenerative Diseases, Movement Disorders, Nervous System Diseases, Basal Ganglia Diseases, Brain Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Study start
- 27 Apr 2018 (actual)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 19 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| [standard STN] + swallowing therapy | Active comparator | Device: [standard STN], Behavioral: Swallowing therapystandard stimulation on subthalamic (STN) contacts plus swallowing therapy |
| [STN+SNr] + swallowing therapy | Experimental | Device: [STN+SNr], Behavioral: Swallowing therapyCombined stimulation of the subthalamic nucleus (STN) and the substantia nigra pars reticulata (SNr) plus swallowing therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [standard STN]Also: subthalamic deep brain stimulationstandard stimulation on subthalamic (STN) contacts High frequency deep brain stimulation with variable (best individual) stimulation on subthalamic contacts | Device | [standard STN] + swallowing therapy |
| [STN+SNr]Also: combined subthalamic and nigral stimulationCombined 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 | Device | [STN+SNr] + swallowing therapy |
| Swallowing therapySwallowing therapy with speech therapist | Behavioural | [STN+SNr] + swallowing therapy, [standard STN] + swallowing therapy |
Primary outcome
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
11 secondary outcomes
MDS-UPDRS parts I, II, III and IV
Time frame: Outcome after eight weeks (V2) with reference to baseline (V1)
Capsit-PD
Time frame: Outcome after eight weeks (V2) with reference to baseline (V1)
Freezing of Gait Assessment Course (FOG-AC)
Time frame: Outcome after eight weeks (V2) with reference to baseline (V1)
PDQ-39
Time frame: Outcome after eight weeks (V2) with reference to baseline (V1)
Dysphagia-related Quality of Life (SWAL-QoL)
Time frame: Outcome after eight weeks (V2) with reference to baseline (V1)
Clinical global impression self
Time frame: Outcome after eight weeks (V2)
Diary on swallowing an related complications
Time frame: Outcome after eight weeks (V2) with reference to baseline (V1)
Site of Swallow reflex initiation
Time frame: Outcome after eight weeks (V2) with reference to baseline (V1)
Test of Mastication and Swallowing solids (TOMASS)
Time frame: Outcome after eight weeks (V2) with reference to baseline (V1)
Pharyngeal Residue Visual Analogue Scale (VAS)
Time frame: Outcome after eight weeks (V2) with reference to baseline (V1)
Functional oral intake scale (FOIS)
Time frame: Outcome after eight weeks (V2) with reference to baseline (V1)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- Background: PubMed 23757762Weiss 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.
- Background: PubMed 27043290Rossi 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.
- Background: PubMed 19001482Chastan 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.
- Background: PubMed 29089922Scholten 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.
- Background: PubMed 28246572Hidding 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.
- Background: PubMed 21287187Weiss 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Weiss, MD principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [standard STN], [STN+SNr] and Swallowing therapy in people with Parkinson's Disease and Dysphagia, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Weiss, MD (0049-7071-29-82340, daniel.weiss@uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penetration Aspiration Scale (time frame: Outcome after eight weeks (V2) with reference to baseline (V1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03470324, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2018.