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New treatment option for Essential Tremor
Official title Home Use Study of Targeted Mechanical Stimulation for Tremor Relief
ClinicalTrials.gov ID: NCT07078422
What this study is testing
- What it's testing
- Subjects will receive prototype devices to be used for participation. The study comprises three phases: 1.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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 people, a diagnosis of essential tremor defined as definite or probable ET based on TRIG criteria
- For PD people, a diagnosis of Parkinson's disease by a Movement Disorder Specialist
- For ET people, 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 people, 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...
- 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 people, 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
The study team makes the final eligibility decision.
Where it's taking place
- Cambridge, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cambridge, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.