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Neurostimulation Device
Felix for Essential Tremor
N/A
Waitlist Available
Led By Rajesh Pahwa, 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
Study Summary
This trial studies how a device can help reduce tremors in adults with essential tremor or 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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)
+5 moreTrial 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
120 Total Patients Enrolled
1 Trials studying Essential Tremor
120 Patients Enrolled for Essential Tremor
Rajesh Pahwa, MDPrincipal InvestigatorUniversity of Kansas Medical Center
5 Previous Clinical Trials
422 Total Patients Enrolled
Richard B Dewey III, MDPrincipal InvestigatorParkinson's Disease and Movement Disorders Center of Boca Raton
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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there any availability for participants in this experiment?
"The clinicaltrials.gov page indicates that this trial is not accepting any applicants at the moment. Originally posted on May 1st 2022 and last updated April 24th 2022, it currently lacks participants; however, there are a total of 538 other trials enrolling individuals right now."
Answered by AI
Who else is applying?
What state do they live in?
Missouri
Kansas
What site did they apply to?
University of Kansas Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2
Why did patients apply to this trial?
I have had ET in both hands my entire life. I have tried a couple medications but they did not work.
PatientReceived 2+ prior treatments
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