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The goal of this clinical study is to compare Felix NeuroAI Wristband and sham device in patients with essential tremor. The main question it aims to answer is:
• Is Felix a safe and efficacious treatment for patients with essential tremor?
Participants will be treated with either Felix or Sham for a period of up to 90 days. After that, they will be eligible to participate in a long-term, open-label study and be treated with Felix.
Full description
The TRANQUIL study is a prospective, randomized, sham-controlled, double-blinded, multi-center, multi-region trial. The objective of this clinical investigation is to evaluate the safety and effectiveness of the Felix NeuroAI Wristband to aid in the relief of upper limb tremor in adults with essential tremor (ET).
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Inclusion criteria
At least 18 years of age.
Willing to provide written, informed consent to participate in the study.
A clinical diagnosis of ET by a movement disorder specialist.
For the dominant hand, a tremor severity score of 2 or higher as measured by one of the TETRAS Performance Subscale (PS) tasks (items 4, 6, 7, and 8) and a total score of 7 or higher across these items. If applicable, this must be met while the patient is on ET treatment.
Stable dosage of anti-tremor medications, if applicable, for 30 days prior to study entry.
Stable dosage of antidepressant medications, if applicable, for 90 days prior to study entry.
Familiar with operating a touch-screen smartphone and connecting to Wi-Fi internet at home.
If necessary, have a dedicated caregiver to help with study required activities, such as putting on the study device, etc.
Willing to comply with study protocol requirements including:
Exclusion criteria
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126 participants in 2 patient groups
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Central trial contact
Head of Clinical Affairs
Data sourced from clinicaltrials.gov
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