Parkinson DiseaseNCT03907007
Effect of Auricular Stimulation on Locomotion in Patients With Parkinson's Disease
A study testing Percutaneous electrical nerve stimulation in people with Parkinson Disease, run by Inventram at 1 site in Turkey (Türkiye).
Trial summary
The effect of auricular stimulation on the locomotion capability in patients with Parkinson's Disease was investigated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Percutaneous electrical nerve stimulation
- 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 Dec 2017to 1 May 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Parkinson's Disease
- H\&Y Stage >= 1
- Existing bradykinesia symptoms
- Existence of one of the symptoms below
- Resting Tremor
- Rigidity
- Walking disorder
Who cannot join
- Cardiac Pacemaker
- Psychiatric diagnosis
- Irregular heart/respiration rate
- Pregnancy
- Alcohol consumption
- Cardiovascular disease history
Show all 9Show fewer
- Wearing an electro-active prosthesis
- Brain surgery history
- Ongoing TENS/PENS therapy
Trial locations and contacts
1 site in 1 country.
About this study
The effect of auricular stimulation on the locomotion capability in patients with Parkinson's Disease was investigated.
Read the detailed description
Effect of the auricular stimulation as a supplementary and alternative usage to Levodopa was investigated in this study. Clinical data were collected through motion capture system while the participants performed the clinical task asked by the investigators.
- Conditions
- Parkinson Disease
- Being tested
- Percutaneous electrical nerve stimulation
- Keywords
- Neurostimulator
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous electrical nerve stimulationDevice
Also called Stimulation & Medication
Stimulation and medication at the same instant
Percutaneous electrical nerve stimulationDevice
Also called Stimulation Only
Stimulation is given without administering medication
| Study group | Role | What they receive |
|---|---|---|
| Sole Medication | No intervention | Monitoring under current prescribed medication |
| Combined stimulation & medication | Active comparator | Concurrent usage of stimulation with the prescribed medication Receives: Device: Percutaneous electrical nerve stimulation |
| Sole Stimulation | Active comparator | Alternating usage of stimulation to the prescribed medication Receives: Device: Percutaneous electrical nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stride length [m]
Measurement through motion capture system
Measured: Time Frame: Baseline
Stride length [m]
Measurement through motion capture system
Measured: Time Frame: 20 minutes after stimulation is initiated
Stride length [m]
Measurement through motion capture system
Measured: Time Frame: 40 minutes after stimulation is initiated
Stride length [m]
Measurement through motion capture system
Measured: Time Frame: 60 minutes after stimulation is initiated
Stride velocity [m/s]
Measurement through motion capture system
Measured: Time Frame: Baseline
Stride velocity [m/s]
Measurement through motion capture system
Measured: Time Frame: 20 minutes after stimulation is initiated
Stride velocity [m/s]
Measurement through motion capture system
Measured: Time Frame: 40 minutes after stimulation is initiated
Stride velocity [m/s]
Measurement through motion capture system
Measured: Time Frame: 60 minutes after stimulation is initiated
Turning Velocity [deg/s]
Measurement through motion capture system
Measured: Time Frame: Baseline
Turning Velocity [deg/s]
Measurement through motion capture system
Measured: Time Frame: 20 minutes after stimulation is initiated
Turning Velocity [deg/s]
Measurement through motion capture system
Measured: Time Frame: 40 minutes after stimulation is initiated
Turning Velocity [deg/s]
Measurement through motion capture system
Measured: Time Frame: 60 minutes after stimulation is initiated
Double Support Percentage during walking [%]
Measurement through motion capture system
Measured: Time Frame: Baseline, 20 minutes, 40 minutes, 60 minutes
Double Support Percentage during walking [%]
Measurement through motion capture system
Measured: Time Frame: 20 minutes after stimulation is initiated
Double Support Percentage during walking [%]
Measurement through motion capture system
Measured: Time Frame: 40 minutes after stimulation is initiated
Double Support Percentage during walking [%]
Measurement through motion capture system
Measured: Time Frame: 60 minutes after stimulation is initiated
Swing Phase Percentage during walking [%]
Measurement through motion capture system
Measured: Time Frame: Baseline
Swing Phase Percentage during walking [%]
Measurement through motion capture system
Measured: Time Frame: 20 minutes after stimulation is initiated
Swing Phase Percentage during walking [%]
Measurement through motion capture system
Measured: Time Frame: 40 minutes after stimulation is initiated
Swing Phase Percentage during walking [%]
Measurement through motion capture system
Measured: Time Frame: 60 minutes after stimulation is initiated
Stance Phase Percentage during walking [%]
Measurement through motion capture system
Measured: Time Frame: Baseline, 20 minutes, 40 minutes, 60 minutes
Stance Phase Percentage during walking [%]
Measurement through motion capture system
Measured: Time Frame: 20 minutes after stimulation is initiated
Stance Phase Percentage during walking [%]
Measurement through motion capture system
Measured: Time Frame: 40 minutes after stimulation is initiated
Stance Phase Percentage during walking [%]
Measurement through motion capture system
Measured: Time Frame: 60 minutes after stimulation is initiated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start1 Dec 2017
- Primary completion1 May 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inventram
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Koç University
- Responsible party
- Sponsor
- Investigators
- Yusuf O Cakmak, MD, PhD, Principal investigator, Otago University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907007
- Sponsor's protocol ID
- Par-03
- Status last verified
- Mar 2020
- First submitted
- 29 Mar 2019
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cakmak YO, Ozsoy B, Ertan S, Cakmak OO, Kiziltan G, Yapici-Eser H, Ozyaprak E, Olcer S, Urey H, Gursoy-Ozdemir Y. Intrinsic Auricular Muscle Zone Stimulation Improves Walking Parameters of Parkinson's Patients Faster Than Levodopa in the Motion Capture Analysis: A Pilot Study. Front Neurol. 2020 Oct 7;11:546123. doi: 10.3389/fneur.2020.546123. eCollection 2020.
PubMed 33117256
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Auricular Stimulation on Locomotion in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03907007
- Acronym / sponsor ID
- Par-03
- Conditions
- Parkinson Disease
- Keywords
- Neurostimulator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- InventramIndustry (pharma, biotech, devices)
- Collaborators
- Koç University
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 8 Apr 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.
The effect of auricular stimulation on the locomotion capability in patients with Parkinson's Disease was investigated.
Detailed description
Effect of the auricular stimulation as a supplementary and alternative usage to Levodopa was investigated in this study. Clinical data were collected through motion capture system while the participants performed the clinical task asked by the investigators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sole Medication | No intervention | –Monitoring under current prescribed medication |
| Combined stimulation & medication | Active comparator | Device: Percutaneous electrical nerve stimulationConcurrent usage of stimulation with the prescribed medication |
| Sole Stimulation | Active comparator | Device: Percutaneous electrical nerve stimulationAlternating usage of stimulation to the prescribed medication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of Parkinson's Disease
- H\&Y Stage >= 1
- Existing bradykinesia symptoms
- Existence of one of the symptoms below
- Resting Tremor
Key exclusion criteria (9 listed)
- Cardiac Pacemaker
- Psychiatric diagnosis
- Irregular heart/respiration rate
- Pregnancy
- Alcohol consumption
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 |
|---|---|---|
| Percutaneous electrical nerve stimulationAlso: Stimulation & MedicationStimulation and medication at the same instant | Device | Combined stimulation & medication |
| Percutaneous electrical nerve stimulationAlso: Stimulation OnlyStimulation is given without administering medication | Device | Sole Stimulation |
Primary outcome
Stride length [m]
Time frame: Time Frame: Baseline
Measurement through motion capture system
Stride length [m]
Time frame: Time Frame: 20 minutes after stimulation is initiated
Measurement through motion capture system
Stride length [m]
Time frame: Time Frame: 40 minutes after stimulation is initiated
Measurement through motion capture system
Stride length [m]
Time frame: Time Frame: 60 minutes after stimulation is initiated
Measurement through motion capture system
Stride velocity [m/s]
Time frame: Time Frame: Baseline
Measurement through motion capture system
Stride velocity [m/s]
Time frame: Time Frame: 20 minutes after stimulation is initiated
Measurement through motion capture system
Stride velocity [m/s]
Time frame: Time Frame: 40 minutes after stimulation is initiated
Measurement through motion capture system
Stride velocity [m/s]
Time frame: Time Frame: 60 minutes after stimulation is initiated
Measurement through motion capture system
Turning Velocity [deg/s]
Time frame: Time Frame: Baseline
Measurement through motion capture system
Turning Velocity [deg/s]
Time frame: Time Frame: 20 minutes after stimulation is initiated
Measurement through motion capture system
Turning Velocity [deg/s]
Time frame: Time Frame: 40 minutes after stimulation is initiated
Measurement through motion capture system
Turning Velocity [deg/s]
Time frame: Time Frame: 60 minutes after stimulation is initiated
Measurement through motion capture system
Double Support Percentage during walking [%]
Time frame: Time Frame: Baseline, 20 minutes, 40 minutes, 60 minutes
Measurement through motion capture system
Double Support Percentage during walking [%]
Time frame: Time Frame: 20 minutes after stimulation is initiated
Measurement through motion capture system
Double Support Percentage during walking [%]
Time frame: Time Frame: 40 minutes after stimulation is initiated
Measurement through motion capture system
Double Support Percentage during walking [%]
Time frame: Time Frame: 60 minutes after stimulation is initiated
Measurement through motion capture system
Swing Phase Percentage during walking [%]
Time frame: Time Frame: Baseline
Measurement through motion capture system
Swing Phase Percentage during walking [%]
Time frame: Time Frame: 20 minutes after stimulation is initiated
Measurement through motion capture system
Swing Phase Percentage during walking [%]
Time frame: Time Frame: 40 minutes after stimulation is initiated
Measurement through motion capture system
Swing Phase Percentage during walking [%]
Time frame: Time Frame: 60 minutes after stimulation is initiated
Measurement through motion capture system
Stance Phase Percentage during walking [%]
Time frame: Time Frame: Baseline, 20 minutes, 40 minutes, 60 minutes
Measurement through motion capture system
Stance Phase Percentage during walking [%]
Time frame: Time Frame: 20 minutes after stimulation is initiated
Measurement through motion capture system
Stance Phase Percentage during walking [%]
Time frame: Time Frame: 40 minutes after stimulation is initiated
Measurement through motion capture system
Stance Phase Percentage during walking [%]
Time frame: Time Frame: 60 minutes after stimulation is initiated
Measurement through motion capture system
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Derived from this study: PubMed 33117256Cakmak YO, Ozsoy B, Ertan S, Cakmak OO, Kiziltan G, Yapici-Eser H, Ozyaprak E, Olcer S, Urey H, Gursoy-Ozdemir Y. Intrinsic Auricular Muscle Zone Stimulation Improves Walking Parameters of Parkinson's Patients Faster Than Levodopa in the Motion Capture Analysis: A Pilot Study. Front Neurol. 2020 Oct 7;11:546123. doi: 10.3389/fneur.2020.546123. eCollection 2020.
- Individual participant dataSharing planned: No
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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.
Yusuf O Cakmak, MD, PhD principal investigator
Otago University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous electrical nerve stimulation in people with Parkinson Disease, run by Inventram 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 7 inclusion and 9 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: finished, as of the sponsor's last update on 10 Mar 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stride length [m] (time frame: Time Frame: Baseline). The study lists 24 primary outcomes in all. 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 NCT03907007, which also lists 1 linked publication.
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 10 Mar 2020.