Parkinson DiseaseNCT06847581
JAME, a Wearable Device to Control Tremor
A study testing JAME in people with Parkinson Disease and Essential Tremor, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
The study is a pilot feasibility study aimed at verifying that (1) tremor can be recognized using an accelerometer placed on the hand area and a data mining algorithm properly trained and (2) TENS applied in the hand area is able to acutely suppress hand tremor respect to the baseline. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Essential Tremor
- What is being tested?
- JAME
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteItaly
- Study dates
- 3 Mar 2022to 10 Oct 2022
- 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
- Subject signed the approved Informed Consent;
- Subject is willing and able to complete the study procedures;
- Subject is ≥ 18 years of age;
- Subject has a certain diagnosis of:
- definite PD, at the start of the disease (respecting the new International Parkinson Disease and Movement Disorder Society diagnostic criteria) and experiences tremor as measured on the UPDRS Part III; or
- ET;
- Subject has a normal cognitive function (MMSE ≥ 24 or MoCA >26).
Who cannot join
- Atypical parkinsonian syndromes - progressive supranuclear palsy, multiple system atrophy, corticobasal degeneration, dementia with Lewy bodies, vascular Parkinsonism, and other rare causes;
- Other pre-existing and active major neurological disease;
- Pre-existing and active (e.g., on chronic medication) major psychiatric disease, such as major depression, schizophrenia, bipolar disease;
- Advanced liver, kidney, cardiac, or pulmonary disease, cancer;
- A terminal medical diagnosis consistent with survival < 1 year;
- Medical implanted devices (e.g. DBS, DUOPATM infusion pump); metal implants; the presence or even a suspicion of metal fragments or moving metal implants in its head or neck, as well as it had prior surgical operations on the head or neck;
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- Dermatological lesions in the area to be treated with the electrical stimulation;
- Major drug dependency, including alcohol (in the investigator's judgment);
- Females who are pregnant or lactating;
- Subject had an important head injury in the past
Trial locations and contacts
1 site in 1 country.
About this study
Official title: JAME: Hand Tremor Recognition and Control Based on Accelerometers and Non-invasive Electrical Stimulation. A Pilot Feasibility Study on PD and ET Patients.
The study is a pilot feasibility study aimed at verifying that (1) tremor can be recognized using an accelerometer placed on the hand area and a data mining algorithm properly trained and (2) TENS applied in the hand area is able to acutely suppress hand tremor respect to the baseline.
Read the detailed description
The study includes 2 different groups: 9 patients with Parkinson's disease with resting tremor alone at the start of their disease (group1), and 5 patients with Essential Tremor (group2). For both groups, the study protocol includes an initial screening visit, in which, after enrollment, the patient's baseline is defined. The experimental session combines both tremor recording and a TENS stimulation treatment.
During the experimental session, the patient wears two devices able to record the upper limb's motion. These devices are commercially available wearable IMU sensors equipped with a triaxial accelerometer, a triaxial gyroscope and triaxial magnetometer. One device is located on the hand, the other on the wrist of the same upper limb, the dominant one. Patients are asked to perform the tasks of the WHIGET scale at baseline and during two different types of electrical stimulation (in a randomly assigned order).
For the recording part, the primary endpoint is the accuracy of the detection system measured as the number of correct detections of tremor episodes on the total tremor episodes recorded by the system (5 seconds windows). For the stimulation part, the primary endpoint is the reduction of upper limb tremor during the stimulation session compared to baseline.
- Conditions
- Parkinson Disease, Essential Tremor
- Being tested
- JAME
- Keywords
- parkinson's disease, essential tremor, transcutaneous electrical nerve stimulation
- Medical subject headings
- Parkinson Disease, Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JAMEDevice
JAME is a wearable device able to monitor movements of the upper limbs and, through an ad-hoc algorithm based on machine learning, can recognize tremor and suppress it through TENS
| Study group | Role | What they receive |
|---|---|---|
| Parkinson'Disease | Experimental | Patients with Parkinson's disease with resting tremor alone at the start of their disease Receives: Device: JAME |
| Essential Tremor | Experimental | Patients with Essential Tremor Receives: Device: JAME |
What is being measured
The primary outcome is the main question the study is designed to answer.
tremor recognition
For the recording part, the primary endpoint is the accuracy of the detection system measured as the number of correct detections of tremor episodes on the total tremor episodes recorded by the system (5 seconds windows);
Measured: 10 minutes
tremor suppression
the primary endpoint is the reduction of upper limb tremor during the stimulation session compared to baseline, measured with the WHIGET scale
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start3 Mar 2022
- Primary completion10 Oct 2022
- Study completion10 Oct 2022
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.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- open label pilot study
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linda Borellini, MD, Principal investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847581
- Sponsor's protocol ID
- JAME2020
- Status last verified
- Mar 2024
- First submitted
- 7 Mar 2024
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- JAME: Hand Tremor Recognition and Control Based on Accelerometers and Non-invasive Electrical Stimulation. A Pilot Feasibility Study on PD and ET Patients.
- ClinicalTrials.gov ID
- NCT06847581
- Acronym / sponsor ID
- JAME2020
- Conditions
- Parkinson Disease, Essential Tremor
- Keywords
- parkinson's disease, essential tremor, transcutaneous electrical nerve stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 26 Feb 2025 (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 study is a pilot feasibility study aimed at verifying that (1) tremor can be recognized using an accelerometer placed on the hand area and a data mining algorithm properly trained and (2) TENS applied in the hand area is able to acutely suppress hand tremor respect to the baseline.
Detailed description
The study includes 2 different groups: 9 patients with Parkinson's disease with resting tremor alone at the start of their disease (group1), and 5 patients with Essential Tremor (group2). For both groups, the study protocol includes an initial screening visit, in which, after enrollment, the patient's baseline is defined. The experimental session combines both tremor recording and a TENS stimulation treatment.
During the experimental session, the patient wears two devices able to record the upper limb's motion. These devices are commercially available wearable IMU sensors equipped with a triaxial accelerometer, a triaxial gyroscope and triaxial magnetometer. One device is located on the hand, the other on the wrist of the same upper limb, the dominant one. Patients are asked to perform the tasks of the WHIGET scale at baseline and during two different types of electrical stimulation (in a randomly assigned order).
For the recording part, the primary endpoint is the accuracy of the detection system measured as the number of correct detections of tremor episodes on the total tremor episodes recorded by the system (5 seconds windows). For the stimulation part, the primary endpoint is the reduction of upper limb tremor during the stimulation session compared to baseline.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open label pilot study
| Arm | Type | Receives |
|---|---|---|
| Parkinson'Disease | Experimental | Device: JAMEPatients with Parkinson's disease with resting tremor alone at the start of their disease |
| Essential Tremor | Experimental | Device: JAMEPatients with Essential Tremor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject signed the approved Informed Consent;
- Subject is willing and able to complete the study procedures;
- Subject is ≥ 18 years of age;
- Subject has a certain diagnosis of:
- Subject has a normal cognitive function (MMSE ≥ 24 or MoCA >26).
Key exclusion criteria (10 listed)
- Atypical parkinsonian syndromes - progressive supranuclear palsy, multiple system atrophy, corticobasal degeneration, dementia with Lewy bodies, vascular Parkinsonism, and other rare causes;
- Other pre-existing and active major neurological disease;
- Pre-existing and active (e.g., on chronic medication) major psychiatric disease, such as major depression, schizophrenia, bipolar disease;
- Advanced liver, kidney, cardiac, or pulmonary disease, cancer;
- A terminal medical diagnosis consistent with survival < 1 year;
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 |
|---|---|---|
| JAMEJAME is a wearable device able to monitor movements of the upper limbs and, through an ad-hoc algorithm based on machine learning, can recognize tremor and suppress it through TENS | Device | Essential Tremor, Parkinson'Disease |
Primary outcome
tremor recognition
Time frame: 10 minutes
For the recording part, the primary endpoint is the accuracy of the detection system measured as the number of correct detections of tremor episodes on the total tremor episodes recorded by the system (5 seconds windows);
tremor suppression
Time frame: 10 minutes
the primary endpoint is the reduction of upper limb tremor during the stimulation session compared to baseline, measured with the WHIGET scale
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 Feb 2025.
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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.
Linda Borellini, MD principal investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JAME in people with Parkinson Disease and Essential Tremor, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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 10 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 Feb 2025. 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 Italy. 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?
tremor recognition (time frame: 10 minutes). 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 Feb 2025.