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NCT06235190 · ClinicalTrials.gov registry record · NA
Assessment of the Safety and Efficacy of the Felix NeuroAI Wristband in Essential Tremor
A NA study of Essential Tremor, sponsored by Fasikl.
- Active
- Registry status
- NA
- Development phase
- 126
- Enrollment target
- 12
- Study locations
NCT06235190: Active NA study of Essential Tremor, sponsored by Fasikl.
NCT06235190 is a NA study of Essential Tremor that is active but no longer recruiting, run by Fasikl. The registered enrollment target is 126 participants, below the 400-participant average among 41 other Essential Tremor trials with a reported enrollment target (68% lower). The trial reports 12 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06235190, a NA study of Essential Tremor, is active but no longer recruiting, sponsored by Fasikl.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 126 participants
- Enrollment target
- 12
- Study locations
Study Summary
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.
Primary Outcome
TETRAS mADL score is a composite sum of items 2 to 11 of the TETRAS ADL subscale and items 6 (bilateral) and 7 (dominant hand) of the TETRAS performance subscale (PS). Each item is scored from 0 to 4, indicating increasing severity of tremor. TETRAS mADL score is calculated as the sum of all 13 items and ranges from 0 to 52.
Conditions Studied
Interventions
- DEVICE Sham Device
- DEVICE Felix NeuroAI Wristband
Study Locations (12)
New York
- Parkinson's Research Centers of America - Long Island - Commack
- Columbia University Irving Medical Center - New York
Zhejiang
- The First Affiliated Hospital, Zhejiang University School of Medicine - Hangzhou
- Sir Run Run Shaw Hospital - Hangzhou
Other
- Xuanwu Hospital Capital Medical University - Beijing
- Tianjin Medical University General Hospital - Tianjin
Arizona
- Barrow Neurological Institute - Phoenix
California
- Parkinson's Research Centers of America - Palo Alto - Palo Alto
Florida
- Parkinson's Disease and Movement Disorders Center of Boca Raton - Boca Raton
Kansas
- The University Of Kansas Medical Center - Kansas City
Ohio
- University of Cincinnati - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2024-02-27 |
| Est. Completion | 2025-11 |
| Phase | NA |
What the registry record for NCT06235190 still lists
NCT06235190 is an interventional study that assigns participants to a tested intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap, below the 400-participant average among 41 other Essential Tremor trials with a reported enrollment target (68% lower).
The record links to 1 condition, with Essential Tremor appearing as the primary indexed condition, and to 2 interventions - of which Sham Device is the first listed.
NCT06235190 lists 12 locations in 9 states (New York, Zhejiang, Other).
Frequently Asked Questions
What is clinical trial NCT06235190 about?
NCT06235190 is a clinical study titled "Assessment of the Safety and Efficacy of the Felix NeuroAI Wristband in Essential Tremor". 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 fo...
What is the current status of trial NCT06235190?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 126 participants. The study started on 2024-02-27. Estimated completion is 2025-11.
What conditions does trial NCT06235190 study?
This clinical trial studies the following conditions: Essential Tremor.
What interventions are being tested in trial NCT06235190?
The interventions under investigation include: Sham Device (DEVICE), Felix NeuroAI Wristband (DEVICE).
Who is sponsoring clinical trial NCT06235190?
This trial is sponsored by Fasikl, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06235190 being conducted?
This trial has 12 study locations across Arizona, California, Florida, Kansas, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06235190's enrollment target sits among peer trials
126 14th of 41 higher than 28 of 41 other Essential Tremor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Essential Tremor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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