JAME, a Wearable Device to Control Tremor (NCT06847581) | Clinical Trial Compass
CompletedNot Applicable
JAME, a Wearable Device to Control Tremor
Italy14 participantsStarted 2022-03-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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 im…
What they're measuring
1
tremor recognition
Timeframe: 10 minutes
2
tremor suppression
Timeframe: 10 minutes
Trial details
NCT IDNCT06847581
SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico