- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05540626
RWE Study Utilizing the Cala Trio Device in Patients With Essential Tremor
Real World Evidence Study Utilizing the Cala Trio Device in Patients With Essential Tremor
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
California
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San Mateo, California, United States, 94404
- Cala Health
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥22years
- Aetna commercial fully insured OR Medicare Advantage population (inclusion of Medicare is contingent upon additional internal approvals)
- 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, 1stor 2nddegree 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
- Willing and able to provide informed consent to participate in the study
- Willing and able to follow study protocol requirements
- Patients with PCP or neurologist provider encounter in past 18months
Exclusion Criteria:
- ICD-10 evidence of a pacemaker or defibrillator or a procedure code indicating pacemaker implantation, electrode renewal or calibration
- ICD-10 evidence of a deep brain stimulator or a procedure code indicating DBS implantation
- CPT/HCPCS evidence of thalamotomy, gamma-knife radio surgical thalamotomy
- NDC and CPT evidence of botulinum toxin the last 6 months as therapeutic injection in the upper limb
- Pregnant during the enrollment period
- Evidence of Parkinson's Disease
- Evidence of epilepsy
- Formal diagnosis of hypothyroidism and treatment
- Formal diagnosis of hyperthyroidism without evidence of treatment
- Formal diagnosis of dementia
- Evidence of Treatment with thyroid hormone supplements (2 Rx claims 28 or more days apart) or evidence of hyperthyroidism (2+ claims, 28 days or more apart)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Standard of Care Arm
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.
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|
Experimental: Intervention with the Cala Trio device (CTD) arm
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.
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transcutaneous afferent patterned stimulation (TAPS)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in tremor power
Time Frame: Month 1
|
Difference in tremor power after stimulation with Cala Trio (treated arm) and baseline tremor power without stimulation (SOC arm) over the first month of the study. Prior to and immediately after each of the first 40 stimulation sessions and every 7th session thereafter, the Cala Trio will direct the patient to perform postural hold tremor tasks to measure tremor power pre and post stimulation. The SOC arm will perform a tremor measurement only, without any stimulation sessions, for 1 month. |
Month 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bain & Findley Activities of Daily Living (ADL) scale subset score
Time Frame: Month 1, 3, 6, 9 and 12
|
Bain & Findley ADL subset score relevant to the stimulated upper limb.
The subset score is the sum of 8 rated tasks.
Each task is rated 1 to 4, where a higher score indicates more severe tremor.
Minimum subset score = 8; Maximum subset score = 32.
|
Month 1, 3, 6, 9 and 12
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Aetna RWE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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