Parkinson DiseaseNCT03797976
The Effects Of DBS Of Subthalamıc Nucleus On Functionality In Patıents With Parkinson's Disease: Short-Term Results
A study testing MIP and MEP in people with Parkinson Disease and Surgery, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial summary
Parkinson's disease is a progressive chronic neurodegenerative disease. In cases where drug treatment is insufficient and drug use is not possible due to drug side effects, highly effective and low-risk surgical treatment options could be used. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Parkinson Disease, Surgery, Respiration; Decreased
- What is being tested?
- MIP and MEP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 30 Dec 2019
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lack of any neurological disease other than Parkinson's
- DBS surgery to be performed in the STN region
Who cannot join
- Patients with advanced cognitive impairment
- Patients with pulmonary, neurological and orthopedic diseases affecting functionalities
- Pregnancy
- Patients in whom the stimulation was canceled due to infection after surgery.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hatay Mustafa Kemal University
Antakya, Hatay, 30100
Bircan Yucekaya, MSc, +903262455516 ext. 15514, bircanyucekaya@hotmail.com
Deran Oskay, PhD, 312 2162600 ext. 2162627, deranoskay@yahoo.com
About this study
Official title: The Effects Of Deep Brain Stimulation Of Subthalamıc Nucleus On Pulmonary Function Tests and Functionality In Patıents With Parkinson's Disease: Short Term Results
Parkinson's disease is a progressive chronic neurodegenerative disease. In cases where drug treatment is insufficient and drug use is not possible due to drug side effects, highly effective and low-risk surgical treatment options could be used. In Parkinson's Disease; findings such as chest wall rigidity and weakness of the respiratory muscle strength occur. The aim of this study was to determine the effect of preop and postop DBS surgery on respiratory muscle strength, respiratory function and physical performance in patients with Parkinson's disease.
Read the detailed description
In the study, at least 10 patients with Parkinson's disease who had DBS surgery in Mustafa Kemal University Research and Practice Hospital, Department of Brain and Nerve Surgery will be evaluated. Demographic-physical features, pulmonary functions, respiratory muscle strength, exercise capacity, functionality, and muscle strength will be evaluated
- Conditions
- Parkinson Disease, Surgery, Respiration; Decreased, Muscle Weakness
- Being tested
- MIP and MEP
- Medical subject headings
- Parkinson Disease, Respiratory Insufficiency, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIP and MEPDevice
Also called Respiratory Function Test, Muscle Test
Pre-op, Post-op of, 1 month after surgery, 3 months after surgery
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's Disease Group | Experimental | MIP and MEP Respiratory Function Test Strength Test Receives: Device: MIP and MEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional exercise capacity
6 minute walking test
Measured: Change from Baseline Functional exercise capacity at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months
Secondary outcomes (4)
Pulmonary functions
Spirometry
Measured: Change from Pulmonary functions at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months
Inspiratory and expiratory muscle strength (MIP, MEP)
Mouth pressure device
Measured: Change from Inspiratory and expiratory muscle strength (MIP, MEP) at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months
Muscle strength
Muscle Testing Device (N)
Measured: Change from Peripheral muscle strength at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months
Grip Test (Peripheral muscle strength)
Hand Held Dynamometer (kgf)
Measured: Change from Peripheral muscle strength at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start1 Jan 2018
- Primary completion30 Sep 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bircan Yücekaya, Mustafa Kemal University
- Investigators
- Deran Oskay, PhD, Study director, Gazi University Faculty of Health Science Department of Physical TherapyBircan Yucekaya, MSc, Study chair, Hatay Mustafa Kemal University School of Physical Therapy and RehabilitationAtilla Yılmaz, Med. Dr, Principal investigator, Hatay Mustafa Kemal University Department of Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03797976
- Sponsor's protocol ID
- Hatay Mustafa Kemal U 1
- Status last verified
- Mar 2019
- First submitted
- 18 Dec 2018
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stemper B, Beric A, Welsch G, Haendl T, Sterio D, Hilz MJ. Deep brain stimulation improves orthostatic regulation of patients with Parkinson disease. Neurology. 2006 Nov 28;67(10):1781-5. doi: 10.1212/01.wnl.0000244416.30605.f1.
PubMed 17130410Trachani E, Constantoyannis C, Sirrou V, Kefalopoulou Z, Markaki E, Chroni E. Effects of subthalamic nucleus deep brain stimulation on sweating function in Parkinson's disease. Clin Neurol Neurosurg. 2010 Apr;112(3):213-7. doi: 10.1016/j.clineuro.2009.11.015. Epub 2009 Dec 22.
PubMed 20022689Hyam JA, Brittain JS, Paterson DJ, Davies RJ, Aziz TZ, Green AL. Controlling the lungs via the brain: a novel neurosurgical method to improve lung function in humans. Neurosurgery. 2012 Feb;70(2):469-77; discussion 477-8. doi: 10.1227/NEU.0b013e318231d789.
PubMed 21841525
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects Of Deep Brain Stimulation Of Subthalamıc Nucleus On Pulmonary Function Tests and Functionality In Patıents With Parkinson's Disease: Short Term Results
- ClinicalTrials.gov ID
- NCT03797976
- Acronym / sponsor ID
- Hatay Mustafa Kemal U 1
- Conditions
- Parkinson Disease, Surgery, Respiration; Decreased, Muscle Weakness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 9 Jan 2019 (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.
Parkinson's disease is a progressive chronic neurodegenerative disease. In cases where drug treatment is insufficient and drug use is not possible due to drug side effects, highly effective and low-risk surgical treatment options could be used. In Parkinson's Disease; findings such as chest wall rigidity and weakness of the respiratory muscle strength occur. The aim of this study was to determine the effect of preop and postop DBS surgery on respiratory muscle strength, respiratory function and physical performance in patients with Parkinson's disease.
Detailed description
In the study, at least 10 patients with Parkinson's disease who had DBS surgery in Mustafa Kemal University Research and Practice Hospital, Department of Brain and Nerve Surgery will be evaluated. Demographic-physical features, pulmonary functions, respiratory muscle strength, exercise capacity, functionality, and muscle strength will be evaluated
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson's Disease Group | Experimental | Device: MIP and MEPMIP and MEP Respiratory Function Test Strength Test |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Lack of any neurological disease other than Parkinson's
- DBS surgery to be performed in the STN region
Key exclusion criteria (4 listed)
- Patients with advanced cognitive impairment
- Patients with pulmonary, neurological and orthopedic diseases affecting functionalities
- Pregnancy
- Patients in whom the stimulation was canceled due to infection after surgery.
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 |
|---|---|---|
| MIP and MEPAlso: Respiratory Function Test, Muscle TestPre-op, Post-op of, 1 month after surgery, 3 months after surgery | Device | Parkinson's Disease Group |
Primary outcome
Functional exercise capacity
Time frame: Change from Baseline Functional exercise capacity at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months
6 minute walking test
4 secondary outcomes
Pulmonary functions
Time frame: Change from Pulmonary functions at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months
Inspiratory and expiratory muscle strength (MIP, MEP)
Time frame: Change from Inspiratory and expiratory muscle strength (MIP, MEP) at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months
Muscle strength
Time frame: Change from Peripheral muscle strength at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months
Grip Test (Peripheral muscle strength)
Time frame: Change from Peripheral muscle strength at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
- Background: PubMed 17130410Stemper B, Beric A, Welsch G, Haendl T, Sterio D, Hilz MJ. Deep brain stimulation improves orthostatic regulation of patients with Parkinson disease. Neurology. 2006 Nov 28;67(10):1781-5. doi: 10.1212/01.wnl.0000244416.30605.f1.
- Background: PubMed 20022689Trachani E, Constantoyannis C, Sirrou V, Kefalopoulou Z, Markaki E, Chroni E. Effects of subthalamic nucleus deep brain stimulation on sweating function in Parkinson's disease. Clin Neurol Neurosurg. 2010 Apr;112(3):213-7. doi: 10.1016/j.clineuro.2009.11.015. Epub 2009 Dec 22.
- Background: PubMed 21841525Hyam JA, Brittain JS, Paterson DJ, Davies RJ, Aziz TZ, Green AL. Controlling the lungs via the brain: a novel neurosurgical method to improve lung function in humans. Neurosurgery. 2012 Feb;70(2):469-77; discussion 477-8. doi: 10.1227/NEU.0b013e318231d789.
- Individual participant dataSharing planned: No
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Parkinson Disease
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.
Deran Oskay, PhD study director
Gazi University Faculty of Health Science Department of Physical Therapy
Bircan Yucekaya, MSc study chair
Hatay Mustafa Kemal University School of Physical Therapy and Rehabilitation
Atilla Yılmaz, Med. Dr principal investigator
Hatay Mustafa Kemal University Department of Neurosurgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIP and MEP in people with Parkinson Disease and Surgery, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
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 2 inclusion and 4 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 15 Mar 2019. 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 Turkey (Türkiye). 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 Deran Oskay, PhD (0312 2162600 ext. 2162627, deranoskay@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional exercise capacity (time frame: Change from Baseline Functional exercise capacity at 3 months(Pre-op,Post-op Off, Post-op 1. month, Post-op 3. Month), an average of 3 months). 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 NCT03797976, which also lists 3 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 15 Mar 2019.