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
This trial does not accept healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Encora Pulse
DeviceThe proposed therapeutic device is a wristband that delivers personalized therapeutic relief to users by adjusting parameters of mechanical vibration, tailored to each individual user's tremor. It measures and characterizes users' upper limb tremor before determining what parameters of mechanical vibration should be applied to stimulate the sensory neurons on the wrist. This study will not be conducted under IDE. It is a non-significant risk due to the non-invasive nature of mechanical vibration.
Treatment groups
80 Participants
are divided into 4 treatment groupsGroup A: AExperimental treatment 1 intervention
Group B: BExperimental treatment 1 intervention
Group C: CExperimental treatment 1 intervention
Group D: DExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Assess the design changes between the alpha and beta versions of the device
This outcome measure assesses participants' experiences through an open-ended survey. Participants will be asked to describe their perceptions, symptoms, and overall experiences with the treatment. No predefined responses are given, and answers will be analyzed qualitatively
Time frame
Data will be collected at baseline and visit one.2
To assess the usability of the beta device in an at-home setting
Characterization of any unforeseen errors during subject interaction with the packaging device and instructions for use during at-home use will be collected using the usability survey which is an open ended, qualitative survey that measures patient usage error and device related satisfaction
Time frame
Data will be collected at baseline, week 1, week 2, month 1, month 2 and month 3.Secondary outcomes
1
To establish the quantitative efficacy in upper limb tremor reduction using the BF-ADL scale
The Bain and Findley Tremor ADL Scale (BF-ADL) is a tool used to assess the impact of essential tremor on a person's ability to perform activities of daily living (ADLs), specifically those involving the upper limbs. The effectiveness of the device in reducing limb tremor will be evaluated using the BF-ADL scale. The scale rates each activity on a 1-to-4 scale: 1 indicates the activity can be done without difficulty, 2 with little effort, 3 with a lot of effort, and 4 means the activity cannot be done alone.
Time frame
Data will be collected at baseline, week 1, week 2, month 1, month 2 and month 3.2
To establish the quantitative efficacy in upper limb tremor reduction using the TETRAS scale
The effectiveness of the device in reducing limb tremor will be evaluated using the TETRAS (Tremor Research Group Essential Tremor Rating Assessment Scale) tool. Tremor severity will be measured on a scale of 0 to 4; a score of 0 indicates no tremor, while a score of 4 represents severe tremor. Scores between 0 and 4 can be assigned using increments of 0.5, allowing for a more nuanced assessment of tremor severity.
Time frame
Data will be collected at baseline, week 1, week 2, month 1, month 2 and month 3.Sponsors and contacts
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Source ClinicalTrials.gov