RWE Study Utilizing the Cala Trio Device in Patients With Essential Tremor
Completed · Not applicable
Conditions studied: Essential Tremor
In brief
The study objective is to evaluate hand tremor relief in the treated hand following stimulation with the Cala Trio Device in adults with essential tremor, and healthcare resource utilization and total healthcare costs over a 12-month period.
Key facts
- Study ID
- NCT05540626
- Run by
- Cala Health, Inc.
- People needed
- 276
- Starts
- 2021-04-08
- Expected to finish
- 2024-03-01
- Last updated by the study team
- 2025-05-07
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Cala Health — San Mateo, California, United States
Full record on ClinicalTrials.gov
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