Parkinson DiseaseNCT03320681
Effect Mechanism Investigation of a Non-invasive Stimulation Device for Rapid Alleviation of Parkinson's Disease Symptoms
A study testing Electrical Stimulation and Dry Needling Stimulation in people with Parkinson Disease, run by Inventram at 1 site in Turkey (Türkiye).
Trial summary
Effect Mechanism Investigation of a Wearable Electrostimulator for Rapid Alleviation of Parkinson's Disease Symptoms 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?
- Electrical Stimulation and Dry Needling Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2017to 31 Dec 2017
- 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
1 site in 1 country.
About this study
Official title: Effect Mechanism of a Non-invasive Stimulation Device for Rapid Alleviation of Parkinson's Disease Symptoms
Effect Mechanism Investigation of a Wearable Electrostimulator for Rapid Alleviation of Parkinson's Disease Symptoms
Read the detailed description
Activation levels of interested regions of the brain will be measured through fMRI technique prior and after the dry needling and active stimulation applications.
- Conditions
- Parkinson Disease
- Being tested
- Electrical Stimulation, Dry Needling 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.
Electrical StimulationDevice
Percutaneous electrical nerve stimulation
Dry Needling StimulationOther
Percutaneous nerve stimulation
| Study group | Role | What they receive |
|---|---|---|
| Active Stimulation | Active comparator | Acupuncture needles will be inserted into the auricular zones and electrical stimulation will be given for 20 minutes. Receives: Device: Electrical Stimulation |
| Dry Needling | Other | Acupuncture needles will be inserted into the auricular zones for 20 minutes. However, no electrical stimulation will be given Receives: Other: Dry Needling Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI - Activation level comparison of the motor and supplementary cortex
Measured: Baseline and PostStim (right after the stimulation is terminated)
fMRI - Activation level comparison of the subthalamic nucleus (STN) and basal ganglia including pedunculopontine nucleus (PPN)
Measured: Baseline and PostStim (right after the stimulation is terminated)
fMRI - STN, PPN and cortical connectivity alterations
Measured: Baseline and PostStim (right 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 posted25 Oct 2017
- Study start20 May 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blind
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inventram
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Koç University
- Responsible party
- Sponsor
- Investigators
- Yusuf O Cakmak, Phd, MD, Principal investigator, Otago UniversityBurak Ozsoy, PhD, Study director, Inventram
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320681
- Sponsor's protocol ID
- Par-02
- Status last verified
- May 2018
- First submitted
- 16 Aug 2017
- Last updated
- 24 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Mechanism of a Non-invasive Stimulation Device for Rapid Alleviation of Parkinson's Disease Symptoms
- ClinicalTrials.gov ID
- NCT03320681
- Acronym / sponsor ID
- Par-02
- Conditions
- Parkinson Disease
- Keywords
- Neurostimulator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- InventramIndustry (pharma, biotech, devices)
- Collaborators
- Koç University
- Study start
- 20 May 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 25 Oct 2017 (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.
Effect Mechanism Investigation of a Wearable Electrostimulator for Rapid Alleviation of Parkinson's Disease Symptoms
Detailed description
Activation levels of interested regions of the brain will be measured through fMRI technique prior and after the dry needling and active stimulation applications.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double-blind
| Arm | Type | Receives |
|---|---|---|
| Active Stimulation | Active comparator | Device: Electrical StimulationAcupuncture needles will be inserted into the auricular zones and electrical stimulation will be given for 20 minutes. |
| Dry Needling | Other | Other: Dry Needling StimulationAcupuncture needles will be inserted into the auricular zones for 20 minutes. However, no electrical stimulation will be given |
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 |
|---|---|---|
| Electrical StimulationPercutaneous electrical nerve stimulation | Device | Active Stimulation |
| Dry Needling StimulationPercutaneous nerve stimulation | Other | Dry Needling |
Primary outcome
fMRI - Activation level comparison of the motor and supplementary cortex
Time frame: Baseline and PostStim (right after the stimulation is terminated)
fMRI - Activation level comparison of the subthalamic nucleus (STN) and basal ganglia including pedunculopontine nucleus (PPN)
Time frame: Baseline and PostStim (right after the stimulation is terminated)
fMRI - STN, PPN and cortical connectivity alterations
Time frame: Baseline and PostStim (right 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 24 May 2018.
- 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, Phd, MD principal investigator
Otago University
Burak Ozsoy, PhD study director
Inventram
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Stimulation and Dry Needling 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 24 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 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?
fMRI - Activation level comparison of the motor and supplementary cortex (time frame: Baseline and PostStim (right after the stimulation is terminated)). The study lists 3 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 24 May 2018.