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Behavioural Intervention

Felix NeuroAI Wristband for Essential Tremor (TRANQUIL Trial)

N/A

Recruiting

Research Sponsored by Fasikl Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up continuously measured up to 1 year

Awards & highlights

TRANQUIL Trial Summary

This trial aims to see if the Felix NeuroAI Wristband is a safe and effective treatment for patients with essential tremor. Participants will be given either the Felix device or a sham device for up

Who is the study for?

This trial is for adults with essential tremor, diagnosed by a specialist. Participants must have a certain level of hand tremor severity and be on stable medication doses if they're taking anti-tremor or antidepressant drugs. They should know how to use a smartphone and Wi-Fi, and may need a caregiver's help for study activities.Check my eligibility

What is being tested?

The study tests the Felix NeuroAI Wristband against a sham (fake) device in people with essential tremor over 90 days to see if it's safe and effective. Afterward, participants can join another study to keep using Felix long-term.See study design

What are the potential side effects?

Since this summary does not provide specific side effects of the Felix NeuroAI Wristband, we can assume that potential side effects will be monitored during the trial as part of assessing its safety.

TRANQUIL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ continuously measured up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~continuously measured up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and continuously measured up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) modified Activities of Daily Living (mADL) score from baseline pre-stimulation to Day 90

Secondary outcome measures

Change in Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) modified Activities of Daily Living (mADL) score from baseline pre-stimulation to 14 days, 30 days, 60 days, 180 days, and 1 year

Clinical Global Impression of Improvement (CGI-I)

Clinical Global Impression of Severity (CGI-S)

+9 more

TRANQUIL Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Felix NeuroAI WristbandExperimental Treatment1 Intervention

Group II: Sham DevicePlacebo Group1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Fasikl Inc.Lead Sponsor

1 Previous Clinical Trials

40 Total Patients Enrolled

1 Trials studying Essential Tremor

40 Patients Enrolled for Essential Tremor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At present, how many distinct locations are simultaneously conducting this experimental investigation?

"The ongoing trial is operating from 4 distinct sites, including Kansas City, Hangzhou, and Tianjin. It is advisable to choose the site nearest to you to reduce travel commitments upon enrollment."

Answered by AI

Are there any available vacancies for participants in this clinical trial?

"Indeed, the details on clinicaltrials.gov reveal that this investigation is actively seeking volunteers. The trial was initially posted on February 27th, 2024, and most recently revised on March 7th, 2024. This research endeavor aims to enroll a total of 120 individuals distributed among four designated sites."

Answered by AI

What is the upper limit in terms of patient enrollment for this medical study?

"Indeed, as per the details on clinicaltrials.gov, this investigation is actively seeking volunteers. The trial was initially listed on February 27th, 2024 and the most recent update occurred on March 7th, 2024. A total of 120 individuals are sought across four designated sites for participation in this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Assessment of the Safety and Efficacy of the Felix NeuroAI Wristband in Essential Tremor

2024. "Assessment of the Safety and Efficacy of the Felix NeuroAI Wristband in Essential Tremor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06235190.

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