JAME, a Wearable Device to Control Tremor

NCT06847581 | Completed

• 1 other identifier: JAME2020
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease; Essential Tremor

Keywords

parkinson's disease, essential tremor, transcutaneous electrical nerve stimulation

Outcome Measures

Primary Outcomes (2)

• 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);

  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

  10 minutes

Study Arms (2)

Parkinson'Disease

EXPERIMENTAL

Patients with Parkinson's disease with resting tremor alone at the start of their disease

Device: JAME

Essential Tremor

EXPERIMENTAL

Patients with Essential Tremor

Device: JAME

Interventions

JAME DEVICE

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

Essential Tremor; Parkinson'Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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;
• 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

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Linda Borellini

Milan, Italy, 20122, Italy

Location

MeSH Terms

Conditions

Parkinson Disease; Essential Tremor

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Linda Borellini, MD

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: open label pilot study

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: February 26, 2025
• Study Start: March 3, 2022
• Primary Completion: October 10, 2022
• Study Completion: October 10, 2022
• Last Updated: February 26, 2025

Record last verified: 2024-03

Locations

IT (1)