Home Use Study of Targeted Mechanical Stimulation for Tremor Relief
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Visits mentioned: 2 visits
- Time periods mentioned: 12 weeks
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Alpha phase: Two remote study visits and an in-home period to gather device usability data on the alpha system."
- "Beta Phase B2 will be conducted using the beta devices for 12 weeks."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
Subjects will receive prototype devices to be used for participation. The study comprises three phases: 1. Alpha phase: Two remote study visits and an in-home period to gather device usability data on the alpha system. The at home period for this phase will be 2 weeks. This phase will be used to confirm that the device and labeling are suitable for in-home use. 2. Beta Phase B1: Beta Phase B1 will be conducted using the beta devices for two in-person or remote, 60 to 90-minute, visits. This phase will be used to assess design changes between alpha and beta versions. 3. Beta Phase B2: Seven remote visits and in-home usage to gather usability and efficacy data on the beta system in-home. Beta Phase B2 will be conducted using the beta devices for 12 weeks. This phase will be used to assess design changes between alpha and beta versions.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
Inclusion Criteria - Alpha and Beta Phase B1 * Age 18 years or older, able to comply with all study procedures and capable of providing informed consent. * Mentally competent to understand and able to perform written, informed consent to participate in the study * A diagnosis of either ET or PD as determined by clinical history * Moderate to severe upper limb tremor Exclusion Criteria - Alpha and Beta Phase B1 * Pregnant women * Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site * History of psoriasis, eczema or atopic dermatitis at the stimulation site * History of peripheral neuropathy in the upper limbs, including carpal tunnel syndrome and diabetic neuropathy * Participant unable to communicate with sponsor/investigator and staff * Any other medical conditions or physical or mental impairments that in the sponsor/investigator's opinion would render the subject unsuitable as a candidate for the study. Inclusion Criteria - Beta Phase B2 * Age 18 years or older, able to comply with all study procedures and capable of providing informed consent * Mentally competent to understand and able to perform written, informed consent to participate in the study * For ET subjects, a diagnosis of essential tremor defined as definite or probable ET based on TRIG criteria * For PD subjects, a diagnosis of Parkinson's disease by a Movement Disorder Specialist * For ET subjects, at least one hand exhibiting tremor \> 2 as assessed by the Essential Tremor Rating Assessment Scale (TETRAS) finger to nose task, duck wing task, OR Archimedes Spiral completed during the Screening visit * For PD subjects, a score \> 2 on at least one of MDS-UPDRS items 3.15, 3.16 or 3.17 At the Screening Visit, a score of \> 3 on one of the following subject-assessed items of the Bain \& Findley Activities of Daily Living Scale (BF-ADL): Use a spoon to drink soup, Hold a cup of tea, Do up buttons, Do up a zipper, Write a letter * Stable medications for at least 30 days prior to enrollment and the ability to maintain tremor medications throughout the duration of study participation * For PD subjects, able to participate in visits in a practically defined OFF state (withdrawal from all tremor medication for 12 hours prior to study visits) * A wrist circumference of 6.0 - 8.1 inches Exclusion Criteria - Beta Phase B2 * Pregnant women * Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site * History of psoriasis, eczema or atopic dermatitis at the stimulation site * History of peripheral neuropathy in the upper limbs, including carpal tunnel syndrome and -diabetic neuropathy * Participant unable to communicate with sponsor/investigator and staff * Any other medical conditions or physical or mental impairments that in the sponsor/investigator's opinion would render the subject unsuitable as a candidate for the study
Study sites (1)
MA
- Encora Therapeutics · Cambridge, MA 02142Allison Davanzo · Study contact · 855-937-5302 · alli@encoratherapeutics.comMore trials in Cambridge