Home Use Study of Targeted Mechanical Stimulation for Tre... | NCT07078422

NCT07078422

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Oder of assessment begins with TETRAS and ends with ADLs	Device: Encora Pulse
B	Experimental	Order of assessment begins with ADLs and ends with TETRAs	Device: Encora Pulse
C	Experimental	Order of assessment begins with TETRAS and ends with ADLs, but both are administered backwards	Device: Encora Pulse
D	Experimental	Order of assessment begins with ADLs and ends with TETRAs, but both are administered backwards	Device: Encora Pulse

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Encora Pulse	Device	The 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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	Data will be collected at baseline and visit one.
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	Data will be collected at baseline, week 1, week 2, month 1, month 2 and month 3.

Secondary Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

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

ID	Term
D009069	Movement Disorders
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases