RWE Study Utilizing the Cala Trio Device in Patients With Essential Tremor
Primary Purpose
Essential Tremor
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cala Trio
Sponsored by
About this trial
This is an interventional treatment trial for Essential Tremor
Eligibility Criteria
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)
Sites / Locations
- Cala Health
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard of Care Arm
Intervention with the Cala Trio device (CTD) arm
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Change in tremor power
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.
Secondary Outcome Measures
Bain & Findley Activities of Daily Living (ADL) scale subset score
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.
Full Information
NCT ID
NCT05540626
First Posted
September 2, 2022
Last Updated
October 2, 2023
Sponsor
Cala Health, Inc.
Collaborators
CVS Health Clinical Trial Services
1. Study Identification
Unique Protocol Identification Number
NCT05540626
Brief Title
RWE Study Utilizing the Cala Trio Device in Patients With Essential Tremor
Official Title
Real World Evidence Study Utilizing the Cala Trio Device in Patients With Essential Tremor
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 8, 2021 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cala Health, Inc.
Collaborators
CVS Health Clinical Trial Services
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
This is a prospective, randomized, dual arm, pragmatic trial in a real-world setting to evaluate the effectiveness and health economics outcomes of the Cala Trio device in reducing hand tremor and improving quality of life as measured by the Bain and Findley Activities of Daily Living (ADL) score relevant to the stimulated upper limb. Healthcare resources utilization and total all-cause healthcare will also be evaluated. The study will recruit approximately 300 patients: 150 in the intervention arm (Cala Trio device)and 150 patients in the standard of care (SOC) arm. Subjects will be randomized to either the intervention arm or the standard of care arm (1:1).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. 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. After the first month, the subjects who were randomized to the SOC arm will cross over to the intervention arm.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care Arm
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention with the Cala Trio device (CTD) arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Cala Trio
Intervention Description
transcutaneous afferent patterned stimulation (TAPS)
Primary Outcome Measure Information:
Title
Change in tremor power
Description
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.
Time Frame
Month 1
Secondary Outcome Measure Information:
Title
Bain & Findley Activities of Daily Living (ADL) scale subset score
Description
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.
Time Frame
Month 1, 3, 6, 9 and 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Cala Health
City
San Mateo
State/Province
California
ZIP/Postal Code
94404
Country
United States
12. IPD Sharing Statement
Learn more about this trial
RWE Study Utilizing the Cala Trio Device in Patients With Essential Tremor
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