Parkinson DiseasePARPIV23NCT06490861
Performance of the Paragit Sleeve to Measure and Monitor Motor Symptoms in Patients With Parkinson's Disease
A study testing Paragit in people with Parkinson Disease, run by Paragit ApS at 1 site in Spain.
Trial summary
This investigation is undertaken to: Evaluate the accuracy and reliability of the device in measuring and recording motor symptoms associated with Parkinson's Disease (PD), and To assess the safety and tolerability of the device in patients with PD. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Paragit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 19 Dec 2023to 31 Dec 2024
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson disease: Clinically diagnosed
- Age ≥ 50 (not in the childbearing aged as defined by Statistics Denmark, 15-49)
- Experiencing at least two of following symptoms and/or side effect on a daily basis:
- Rigidity
- Tremor
- Bradykinesia
Show all 10Show fewer
- Dyskinesia (treatment side effect)
- Provision of informed consent, i.e., the subject must be able to:
- Read and understand the Patient Information and Consent Form
- Sign the Patient Information and Consent Form.
Who cannot join
- Known allergy/hypersensitivity to any material in direct contact with the skin (stainless steel, silicone and polyester)
- MMSE <24
- Other neurological diseases
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Beata María Ana
Madrid
Juan Pablo Romero, PhD, +34, p.romero.prof@ufv.es
About this study
Official title: An Open Multi-centre Investigation to Evaluate the Performance of the Paragit Sleeve With build-in sEMG Sensors, Kinetic Sensors, and Smart-textile to Measure and Monitor Motor Symptoms and Treatment-induced Dyskinesia in Patients With Parkinson's Disease
This investigation is undertaken to:
- Evaluate the accuracy and reliability of the device in measuring and recording motor symptoms associated with Parkinson's Disease (PD), and
- To assess the safety and tolerability of the device in patients with PD.
- Conditions
- Parkinson Disease
- Being tested
- Paragit
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParagitDevice
Sleeve to quantify symptoms
| Study group | Role | What they receive |
|---|---|---|
| Paragit | Experimental | Sleeve to quantify symptoms Receives: Device: Paragit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tremor
Tremor will be assessed using the device, measured with superficial EMG [Volts], and inertial measurement unit [m/s2]. Correlation with clinical gold-standard (MDS-UPDRS) will be studied.
Measured: During the clinical assessment, and for the following 24h.
Bradykinesia
Bradykinesia will be assessed using the device, measured inertial measurement unit [m/s2]. Correlation with clinical gold-standard (MDS-UPDRS) will be studied.
Measured: During the clinical assessment, and for the following 24h.
Rigidity
The device will assess rigidity, measured with superficial EMG [Volts], and inertial measurement unit [m/s2]. Correlation with clinical gold-standard (MDS-UPDRS) will be studied.
Measured: During the clinical assessment, and for the following 24h.
Dyskinesia
The device will assess rigidity, measured with superficial EMG [Volts], and inertial measurement unit [m/s2]. Correlation with clinical gold-standard (MDS-UPDRS) will be studied.
Measured: During the clinical assessment, and for the following 24h.
Secondary outcomes (2)
Safety
Safety of the Paragit Sleeve by assessment of device deficiencies and adverse events, non-serious and serious, rated for causality.
Measured: During the clinical assessment , and for the following 24h.
Usability
The usability of the device will be studied using a questionnaire.
Measured: During the clinical assessment , and for the following 24h.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start19 Dec 2023
- Primary completion1 Aug 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paragit ApS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490861
- Sponsor's protocol ID
- PARPIV23
- Acronym
- PARPIV23
- Status last verified
- Jul 2024
- First submitted
- 13 Jun 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Multi-centre Investigation to Evaluate the Performance of the Paragit Sleeve With build-in sEMG Sensors, Kinetic Sensors, and Smart-textile to Measure and Monitor Motor Symptoms and Treatment-induced Dyskinesia in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06490861
- Acronym / sponsor ID
- PARPIV23 / PARPIV23
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Paragit ApSIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 Jul 2024 (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.
This investigation is undertaken to:
- Evaluate the accuracy and reliability of the device in measuring and recording motor symptoms associated with Parkinson's Disease (PD), and
- To assess the safety and tolerability of the device in patients with PD.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paragit | Experimental | Device: ParagitSleeve to quantify symptoms |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Parkinson disease: Clinically diagnosed
- Age ≥ 50 (not in the childbearing aged as defined by Statistics Denmark, 15-49)
- Experiencing at least two of following symptoms and/or side effect on a daily basis:
- Provision of informed consent, i.e., the subject must be able to:
Key exclusion criteria (3 listed)
- Known allergy/hypersensitivity to any material in direct contact with the skin (stainless steel, silicone and polyester)
- MMSE <24
- Other neurological diseases
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 |
|---|---|---|
| ParagitSleeve to quantify symptoms | Device | Paragit |
Primary outcome
Tremor
Time frame: During the clinical assessment, and for the following 24h.
Tremor will be assessed using the device, measured with superficial EMG [Volts], and inertial measurement unit [m/s2]. Correlation with clinical gold-standard (MDS-UPDRS) will be studied.
Bradykinesia
Time frame: During the clinical assessment, and for the following 24h.
Bradykinesia will be assessed using the device, measured inertial measurement unit [m/s2]. Correlation with clinical gold-standard (MDS-UPDRS) will be studied.
Rigidity
Time frame: During the clinical assessment, and for the following 24h.
The device will assess rigidity, measured with superficial EMG [Volts], and inertial measurement unit [m/s2]. Correlation with clinical gold-standard (MDS-UPDRS) will be studied.
Dyskinesia
Time frame: During the clinical assessment, and for the following 24h.
The device will assess rigidity, measured with superficial EMG [Volts], and inertial measurement unit [m/s2]. Correlation with clinical gold-standard (MDS-UPDRS) will be studied.
2 secondary outcomes
Safety
Time frame: During the clinical assessment , and for the following 24h.
Usability
Time frame: During the clinical assessment , and for the following 24h.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paragit in people with Parkinson Disease, run by Paragit ApS at 1 site in Spain.
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 10 inclusion and 3 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 8 Jul 2024. 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 Spain. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tremor (time frame: During the clinical assessment, and for the following 24h.). The study lists 4 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 8 Jul 2024.