Parkinson's DiseaseNCT02722824
Efficacy of a Non-invasive Device for Alleviation of Parkinson's Disease Symptoms
A study testing Electro-stimulation in people with Parkinson's Disease, run by Koç University at 2 sites in Turkey (Türkiye).
Trial summary
Investigation efficacy of a non-invasive wearable electrostimulator device where the supplementary motor area, premotor area and/or subthalamic nucleus are stimulated bilaterally and extracranially. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Electro-stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- Nov 2015to Jun 2016
- 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 >= 2
- 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
2 sites in 1 country.
Turkey (Türkiye)2 sites
Istanbul University
Istanbul
Koc University Hospital
Istanbul
About this study
Official title: Efficacy Investigation of a Non-invasive Wearable Electrostimulation Device for Alleviation of Parkinson's Disease Symptoms
Investigation efficacy of a non-invasive wearable electrostimulator device where the supplementary motor area, premotor area and/or subthalamic nucleus are stimulated bilaterally and extracranially.
- Conditions
- Parkinson's Disease
- Being tested
- Electro-stimulation, Placebo
- Keywords
- motor symptoms
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electro-stimulationDevice
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Wearable stimulators will be placed on the patients and controls without stimulation for 20 minutes Receives: Other: Placebo |
| Active Stimulation | Experimental | Instrinsic auricular muscles will be stimulated for 20 minutes Receives: Device: Electro-stimulation |
| Sham | Sham comparator | An area out of the instrinsic auricular muscles region will be stimulated with the same parameters of the active group for 20 minutes Receives: Device: Electro-stimulation |
| Passive Control | No intervention | Only the electrodes of the wearable stimulators will be inserted but there will not be electrostimulation for 20 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the UPDRS Motor Score (Part III)
Evaluation of patients' disease level with UPDRS examination at the middle of the stimulation
Measured: 10 minutes after the stimulation is initiated.
Change in the UPDRS Motor Score (Part III)
Evaluation of patients' disease level with UPDRS examination 30 minutes after the stimulation is terminated.
Measured: 30 minutes after the stimulation is terminated.
Secondary outcomes (28)
Change in the gait and balance parameters (cadence)
cadence
Measured: 10 minutes after the stimulation is initiated.
Change in the gait and balance parameters (Stride length)
Stride length in meters
Measured: 10 minutes after the stimulation is initiated.
Change in the gait and balance parameters (Stride velocity)
Stride velocity in m/s
Measured: 10 minutes after the stimulation is initiated.
Change in the gait and balance parameters
Arm Swing Rate
Measured: 10 minutes after the stimulation is initiated.
Change in the gait and balance parameters
Arm Range of Motion
Measured: 10 minutes after the stimulation is initiated.
Change in the gait and balance parameters
Sit to Stand Duration
Measured: 10 minutes after the stimulation is initiated.
Change in the gait and balance parameters
Sit to Stand Peak Trunk Velocity
Measured: 10 minutes after the stimulation is initiated.
Change in the gait and balance parameters
Sit to Stand Peak Trunk Angle
Measured: 10 minutes after the stimulation is initiated.
Change in the gait and balance parameters
Leg Swing Rate
Measured: 10 minutes after the stimulation is initiated.
Change in the gait and balance parameters
Leg Range of Motion
Measured: 10 minutes after the stimulation is initiated.
Change in the gait and balance parameters
Turn to Sit Peak Turn Velocity
Measured: 10 minutes after the stimulation is initiated.
Change in the gait and balance parameters
Turn-to-Sit Trunk Range of Motion in Sagittal Plane
Measured: 10 minutes after the stimulation is initiated.
Change in the gait and balance parameters
Knee Range of Motion
Measured: 10 minutes after the stimulation is initiated.
Change in the gait and balance parameters
Trunk Joint Angles
Measured: 10 minutes after the stimulation is initiated.
Change in the gait and balance parameters (cadence)
cadence
Measured: 30 minutes after the stimulation is terminated.
Change in the gait and balance parameters (Stride length)
Stride length in meters
Measured: 30 minutes after the stimulation is terminated.
Change in the gait and balance parameters (Stride velocity)
Stride velocity in m/s
Measured: 30 minutes after the stimulation is terminated.
Change in the gait and balance parameters
Arm Swing Rate
Measured: 30 minutes after the stimulation is terminated.
Change in the gait and balance parameters
Arm Range of Motion
Measured: 30 minutes after the stimulation is terminated.
Change in the gait and balance parameters
Sit to Stand Duration
Measured: 30 minutes after the stimulation is terminated.
Change in the gait and balance parameters
Sit to Stand Peak Trunk Velocity
Measured: 30 minutes after the stimulation is terminated.
Change in the gait and balance parameters
Sit to Stand Peak Trunk Angle
Measured: 30 minutes after the stimulation is terminated.
Change in the gait and balance parameters
Leg Swing Rate
Measured: 30 minutes after the stimulation is terminated.
Change in the gait and balance parameters
Leg Range of Motion
Measured: 30 minutes after the stimulation is terminated.
Change in the gait and balance parameters
Turn-to-Sit Peak Turn Velocity
Measured: 30 minutes after the stimulation is terminated.
Change in the gait and balance parameters
Turn-to-Sit Trunk Range of Motion
Measured: 30 minutes after the stimulation is terminated.
Change in the gait and balance parameters
Knee Range of Motion
Measured: 30 minutes after the stimulation is terminated.
Change in the gait and balance parameters
Trunk Joint Angles
Measured: 30 minutes after the stimulation is terminated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study startNov 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University
- Responsible party
- Principal investigator, Yasemin Gürsoy Özdemir, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722824
- Sponsor's protocol ID
- Par-01
- Status last verified
- Jul 2017
- First submitted
- 6 Mar 2016
- Last updated
- 26 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Investigation of a Non-invasive Wearable Electrostimulation Device for Alleviation of Parkinson's Disease Symptoms
- ClinicalTrials.gov ID
- NCT02722824
- Acronym / sponsor ID
- Par-01
- Conditions
- Parkinson's Disease
- Keywords
- motor symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Collaborators
- Istanbul University
- Study start
- Nov 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 30 Mar 2016 (estimated)
- 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.
Investigation efficacy of a non-invasive wearable electrostimulator device where the supplementary motor area, premotor area and/or subthalamic nucleus are stimulated bilaterally and extracranially.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboWearable stimulators will be placed on the patients and controls without stimulation for 20 minutes |
| Active Stimulation | Experimental | Device: Electro-stimulationInstrinsic auricular muscles will be stimulated for 20 minutes |
| Sham | Sham comparator | Device: Electro-stimulationAn area out of the instrinsic auricular muscles region will be stimulated with the same parameters of the active group for 20 minutes |
| Passive Control | No intervention | –Only the electrodes of the wearable stimulators will be inserted but there will not be electrostimulation for 20 minutes |
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 >= 2
- 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 |
|---|---|---|
| Electro-stimulation | Device | Active Stimulation, Sham |
| Placebo | Other | Placebo |
Primary outcome
Change in the UPDRS Motor Score (Part III)
Time frame: 10 minutes after the stimulation is initiated.
Evaluation of patients' disease level with UPDRS examination at the middle of the stimulation
Change in the UPDRS Motor Score (Part III)
Time frame: 30 minutes after the stimulation is terminated.
Evaluation of patients' disease level with UPDRS examination 30 minutes after the stimulation is terminated.
28 secondary outcomes
Change in the gait and balance parameters (cadence)
Time frame: 10 minutes after the stimulation is initiated.
Change in the gait and balance parameters (Stride length)
Time frame: 10 minutes after the stimulation is initiated.
Change in the gait and balance parameters (Stride velocity)
Time frame: 10 minutes after the stimulation is initiated.
Change in the gait and balance parameters
Time frame: 10 minutes after the stimulation is initiated.
Change in the gait and balance parameters
Time frame: 10 minutes after the stimulation is initiated.
Change in the gait and balance parameters
Time frame: 10 minutes after the stimulation is initiated.
Change in the gait and balance parameters
Time frame: 10 minutes after the stimulation is initiated.
Change in the gait and balance parameters
Time frame: 10 minutes after the stimulation is initiated.
Change in the gait and balance parameters
Time frame: 10 minutes after the stimulation is initiated.
Change in the gait and balance parameters
Time frame: 10 minutes after the stimulation is initiated.
Change in the gait and balance parameters
Time frame: 10 minutes after the stimulation is initiated.
Change in the gait and balance parameters
Time frame: 10 minutes after the stimulation is initiated.
Change in the gait and balance parameters
Time frame: 10 minutes after the stimulation is initiated.
Change in the gait and balance parameters
Time frame: 10 minutes after the stimulation is initiated.
Change in the gait and balance parameters (cadence)
Time frame: 30 minutes after the stimulation is terminated.
Change in the gait and balance parameters (Stride length)
Time frame: 30 minutes after the stimulation is terminated.
Change in the gait and balance parameters (Stride velocity)
Time frame: 30 minutes after the stimulation is terminated.
Change in the gait and balance parameters
Time frame: 30 minutes after the stimulation is terminated.
Change in the gait and balance parameters
Time frame: 30 minutes after the stimulation is terminated.
Change in the gait and balance parameters
Time frame: 30 minutes after the stimulation is terminated.
Change in the gait and balance parameters
Time frame: 30 minutes after the stimulation is terminated.
Change in the gait and balance parameters
Time frame: 30 minutes after the stimulation is terminated.
Change in the gait and balance parameters
Time frame: 30 minutes after the stimulation is terminated.
Change in the gait and balance parameters
Time frame: 30 minutes after the stimulation is terminated.
Change in the gait and balance parameters
Time frame: 30 minutes after the stimulation is terminated.
Change in the gait and balance parameters
Time frame: 30 minutes after the stimulation is terminated.
Change in the gait and balance parameters
Time frame: 30 minutes after the stimulation is terminated.
Change in the gait and balance parameters
Time frame: 30 minutes after the stimulation is terminated.
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 26 Jul 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electro-stimulation in people with Parkinson's Disease, run by Koç University at 2 sites 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 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Change in the UPDRS Motor Score (Part III) (time frame: 10 minutes after the stimulation is initiated.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jul 2017.