Home Use Study of Targeted Mechanical Stimulation for Tremor Relief

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEncora, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Encora Pulse

Treatment groups

80 Participants
are divided into 4 treatment groups

Sponsors and collaborators