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Behavioural Intervention
Cala Trio Device for Essential Tremor
N/A
Waitlist Available
Research Sponsored by Cala Health, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Two ICD claims for ET, at least seven days apart, in the last three years OR one ICD claim for ET followed by at least one dispensed pharmaceutical treatment for ET
Contraindication to standard pharmacological therapy (Asthma, COPD, 1st or 2nd degree heart block) OR indicator of poor pharmacological acceptability as evidenced by drug switching behaviors OR indicator of drug resistance as evidenced by the use of third-line drug therapies including Clozapine, Mirtazapine, Gabapentin, Topiramate, Clonazepam or Alprazolam
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 1, 3, 6, 9 and 12
Awards & highlights
Study Summary
This trial will test a new device to see if it relieves hand tremor in adults with essential tremor. It will also track total healthcare costs over a 12-month period.
Who is the study for?
This trial is for adults over 22 with essential tremor who can't use standard drugs due to conditions like asthma or heart block, or haven't responded well to other treatments. They must have seen a doctor recently and be part of Aetna's insured or Medicare Advantage groups. People with Parkinson's, certain thyroid disorders, brain surgeries, epilepsy, dementia, or those pregnant can't join.Check my eligibility
What is being tested?
The Cala Trio Device is being tested in this study. It aims to provide relief from hand tremors in patients with essential tremor. The device's effectiveness and its impact on healthcare costs will be monitored over one year.See study design
What are the potential side effects?
While the specific side effects are not listed here, devices like the Cala Trio may cause discomfort at the site of application, skin irritation, or temporary increase in tremor during usage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had at least two insurance claims for essential tremor, or one claim followed by treatment.
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I cannot take standard medications due to my asthma, COPD, or heart issues, or my medications do not work well for me.
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I am covered by Aetna commercial insurance or Medicare Advantage.
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I am 22 years old or older.
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I am 22 years old or older.
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I have had at least two insurance claims for essential tremor, or one claim followed by treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 1, 3, 6, 9 and 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 1, 3, 6, 9 and 12
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 power
Secondary outcome measures
Bain & Findley Activities of Daily Living (ADL) scale subset score
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention with the Cala Trio device (CTD) armExperimental Treatment1 Intervention
Tremor power after stimulation with Cala Trio. Subjects in the intervention arm will wear the device at home for a period of 12 months, during which they will deliver 40 min stimulation sessions, which can be started and stopped on demand.
Group II: Standard of Care ArmActive Control1 Intervention
Baseline tremor power without stimulation (SOC arm) over the first month of the study. Subjects in the SOC arm will be asked to measure their tremor severity by doing daily postural holds with the Cala Trio device without actual stimulation.
Find a Location
Who is running the clinical trial?
CVS Health Clinical Trial ServicesUNKNOWN
CVS Clinical Trial ServicesUNKNOWN
Cala Health, Inc.Lead Sponsor
8 Previous Clinical Trials
558 Total Patients Enrolled
5 Trials studying Essential Tremor
458 Patients Enrolled for Essential Tremor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with dementia.I have had at least two insurance claims for essential tremor, or one claim followed by treatment.I cannot take standard medications due to my asthma, COPD, or heart issues, or my medications do not work well for me.I have been treated for thyroid issues with medication or have had hyperthyroidism.You have seen a neurologist or had treatment for PCP in the last 18 months.I cannot take standard medications due to my asthma, COPD, or heart issues, or they haven't worked for me.I am covered by Aetna commercial insurance or Medicare Advantage.I cannot take standard medications due to my asthma, COPD, or heart issues, or they haven't worked for me.I have been diagnosed with Parkinson's Disease.I have been diagnosed with hyperthyroidism and have not received any treatment.You have seen a doctor for pneumonia (PCP) or a neurologist in the last 18 months.I am 22 years old or older.I have received a botulinum toxin injection in my arm in the last 6 months.I have undergone a specific brain surgery or gamma-knife procedure.I have been diagnosed with and am being treated for hypothyroidism.You have a pacemaker or defibrillator implanted in your body.You have a medical code showing that you have had a deep brain stimulator implanted.I am 22 years old or older.I have had at least two insurance claims for essential tremor, or one claim followed by treatment.I am covered by Aetna commercial insurance or Medicare Advantage.I have been diagnosed with epilepsy.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care Arm
- Group 2: Intervention with the Cala Trio device (CTD) arm
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: NCT05540626 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible to participate in this medical research presently?
"This investigation, posted on August 4th 2021 and last reviewed November 10 2022 is no longer accepting patients. Nevertheless, there are still 51 current studies looking for volunteers right now."
Answered by AI
Who else is applying?
What state do they live in?
Texas
Connecticut
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Cala Health
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
Want to try something different. I've tried the original Cali Trio devise and haven't seen much if any improvement. I'm hoping the new devise would be more successful.
PatientReceived 1 prior treatment
My tremors are getting worse. I’m on medications that haven’t helped, if I up the dosage (per doctors recommendation) I get dizzy and/or nauseated. If I stay at the base dosage my tremors badly affect my fine motor skills.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
How long do trials take? Would I need to go to San Mateo more than once?
PatientReceived 1 prior treatment
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