Movement Disorders (Incl Parkinsonism)COMMANDNCT05462080
Correlation of Motor Metrics and Neurological Data
An observational study of Movement Disorders (Incl Parkinsonism), run by Ceraxis Health, Inc at 1 site in United States.
Trial summary
This is a pilot study to collect data with the Ceraxis product and standard movement disorders tests in order to prove and codify potential correlations. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Movement Disorders (Incl Parkinsonism)
- What is being tested?
- Ceraxis product
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2022to 31 Aug 2023
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Movement disorders patients being treated at the site
Who may be able to join
- Adult with a diagnosis of idiopathic Parkinson's disease or essential tremor by a movement disorders neurologist
- Age greater than or equal to 21 years
- Hoehn and Yahr stage I-III
- Ability to ambulate 200+ meters independently
- Ability to follow 2-step commands
- Clinically responsive to medication or Deep Brain Stimulation (DBS)
- Clinically optimized medication or DBS for at least six months
- Able to tolerate withdrawal of medication and/or DBS
Who cannot join
- Any comorbidity which would exclude them from being able to use the Ceraxis product
- Inability to learn how to use the system
- Diagnosis of dementia or impairment that compromises the ability to provide informed consent
- Neurological disease other than Parkinson's disease or essential tremor (i.e. multiple sclerosis, stroke with residual motor deficits)
- Musculoskeletal injury that significantly alters gait
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation of Motor Metrics and Neurological Data (COMMAND)
This is a pilot study to collect data with the Ceraxis product and standard movement disorders tests in order to prove and codify potential correlations.
- Conditions
- Movement Disorders (Incl Parkinsonism)
- Being tested
- Ceraxis product
- Medical subject headings
- Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceraxis productDiagnostic test
All patients will have their symptoms evaluated using the Ceraxis product
| Study group | Role | What they receive |
|---|---|---|
| Movement Disorders Patients | Not described Receives: Diagnostic Test: Ceraxis product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of data with Ceraxis product (stylus product with a built-in Inertial Measurement Unit (IMU) which includes a 3-axis accelerometer, gyroscope, and magnetometer, as well as a force sensing tip)
Patients will be guided through a set of actions while the sensors record movement data on their upper and lower extremity motor symptoms. This data will be correlated with the secondary outcome measures post hoc.
Measured: Day 1
Secondary outcomes (7)
UPDRS-I, UPDRS-II, and UPDRS-III assessment for patients with Parkinson's disease
Measured: Day 1
TETRAS tremor rating scale for patients with Essential Tremor
Measured: Day 1
Upper extremities motor strength, assessed by neurological examination
Measured: Day 1
Coordination test for the upper extremities to evaluate dysdiadochokinesia
Measured: Day 1
Archimedes Spiral task
Measured: Day 1
Freezing of Gait questionnaire
Measured: Day 1
Usage Survey
Custom survey given to patients to collect their impressions of the Ceraxis product
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start10 Nov 2022
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Movement Disorders (Incl Parkinsonism)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ceraxis Health, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462080
- Sponsor's protocol ID
- REDD 0001
- Acronym
- COMMAND
- Status last verified
- Aug 2024
- First submitted
- 6 Jul 2022
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Motor Metrics and Neurological Data (COMMAND)
- ClinicalTrials.gov ID
- NCT05462080
- Acronym / sponsor ID
- COMMAND / REDD 0001
- Conditions
- Movement Disorders (Incl Parkinsonism)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Ceraxis Health, IncIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 18 Jul 2022 (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 is a pilot study to collect data with the Ceraxis product and standard movement disorders tests in order to prove and codify potential correlations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Movement Disorders Patients | – | Diagnostic Test: Ceraxis product |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Movement disorders patients being treated at the site
Key inclusion criteria (8 listed)
- Adult with a diagnosis of idiopathic Parkinson's disease or essential tremor by a movement disorders neurologist
- Age greater than or equal to 21 years
- Hoehn and Yahr stage I-III
- Ability to ambulate 200+ meters independently
- Ability to follow 2-step commands
Key exclusion criteria (5 listed)
- Any comorbidity which would exclude them from being able to use the Ceraxis product
- Inability to learn how to use the system
- Diagnosis of dementia or impairment that compromises the ability to provide informed consent
- Neurological disease other than Parkinson's disease or essential tremor (i.e. multiple sclerosis, stroke with residual motor deficits)
- Musculoskeletal injury that significantly alters gait
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 |
|---|---|---|
| Ceraxis productAll patients will have their symptoms evaluated using the Ceraxis product | Diagnostic test | Movement Disorders Patients |
Primary outcome
Collection of data with Ceraxis product (stylus product with a built-in Inertial Measurement Unit (IMU) which includes a 3-axis accelerometer, gyroscope, and magnetometer, as well as a force sensing tip)
Time frame: Day 1
Patients will be guided through a set of actions while the sensors record movement data on their upper and lower extremity motor symptoms. This data will be correlated with the secondary outcome measures post hoc.
7 secondary outcomes
UPDRS-I, UPDRS-II, and UPDRS-III assessment for patients with Parkinson's disease
Time frame: Day 1
TETRAS tremor rating scale for patients with Essential Tremor
Time frame: Day 1
Upper extremities motor strength, assessed by neurological examination
Time frame: Day 1
Coordination test for the upper extremities to evaluate dysdiadochokinesia
Time frame: Day 1
Archimedes Spiral task
Time frame: Day 1
Freezing of Gait questionnaire
Time frame: Day 1
Usage Survey
Time frame: Day 1
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 20 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Recruiting
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Recruiting
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Movement Disorders (Incl Parkinsonism), run by Ceraxis Health, Inc at 1 site in United States.
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 8 inclusion and 5 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 20 Aug 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 United States. 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?
Collection of data with Ceraxis product (stylus product with a built-in Inertial Measurement Unit (IMU) which includes a 3-axis accelerometer, gyroscope, and magnetometer, as well as a force sensing tip) (time frame: Day 1). 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 20 Aug 2024.