Usability Study of Targeted Vibration Therapy for Tremor Relief

Encora

Status: Enrolling

Conditions: Essential Tremor; Parkinson's Disease

Treatments: Device: Encora Pulse

Study type: Interventional

Funder types: Industry

Identifiers

NCT07078422

20232333

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

80 participants in 4 patient groups

A

Experimental group

Description:

Oder of assessment begins with TETRAS and ends with ADLs

Treatment:

Device: Encora Pulse

B

Experimental group

Description:

Order of assessment begins with ADLs and ends with TETRAs

Treatment:

Device: Encora Pulse

C

Experimental group

Description:

Order of assessment begins with TETRAS and ends with ADLs, but both are administered backwards

Treatment:

Device: Encora Pulse

D

Experimental group

Description:

Order of assessment begins with ADLs and ends with TETRAs, but both are administered backwards

Treatment:

Device: Encora Pulse