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Neurostimulation Device
Felix for Essential Tremor
N/A
Waitlist Available
Led By Richard B Dewey III, MD
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 baseline to 7 days
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the Felix system, a device to reduce arm shaking, in adults with essential tremor and Parkinson's disease.
Eligible Conditions
- Essential Tremor
- Parkinson's Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 7 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 7 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinical Global Impression of Improvement (CGI-I)
Clinical Global Impression of Severity (CGI-S)
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: FelixExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Felix
2023
N/A
~40
Find a Location
Who is running the clinical trial?
Fasikl Inc.Lead Sponsor
1 Previous Clinical Trials
126 Total Patients Enrolled
1 Trials studying Essential Tremor
126 Patients Enrolled for Essential Tremor
Richard B Dewey III, MDPrincipal InvestigatorParkinson's Disease and Movement Disorders Center of Boca Raton
Rajesh Pahwa, MDPrincipal InvestigatorUniversity of Kansas Medical Center
5 Previous Clinical Trials
422 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with essential tremor (ET) by a doctor.You are currently using drugs or alcohol excessively.You have received a Botulinum Toxin injection for hand tremor within the past 4 months before joining the study.You have had a seizure within the past 6 months and your epilepsy is not currently under control.You have previously had a limb amputated or have a known nerve condition that causes symptoms in your arm or hand.You have previously had a specific type of brain surgery called thalamotomy to treat tremors.You have any swollen, infected, or inflamed areas on your skin, open wounds, or cancerous skin lesions where the treatment will be applied.
Research Study Groups:
This trial has the following groups:- Group 1: Felix
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Essential Tremor Patient Testimony for trial: Trial Name: NCT05842434 — N/A
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