RWE Study Utilizing the Cala Trio Device in Patients With Essential Tremor

NCT05540626 | Completed FDA Device

• 1 other identifier: Aetna RWE
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

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.

Conditions

Essential Tremor

Outcome Measures

Primary Outcomes (1)

• 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.

  1 Month

Secondary Outcomes (2)

• Bain & Findley Activities of Daily Living (BF-ADL) scale subset score

  12 Months

• Tremor power improvement ratio (TPIR)

  12 Months

Study Arms (2)

Standard of Care Arm

NO 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.

Intervention with the Cala Trio device (CTD) arm

EXPERIMENTAL

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.

Device: Cala Trio

Interventions

Cala Trio DEVICE

transcutaneous afferent patterned stimulation (TAPS)

Intervention with the Cala Trio device (CTD) arm

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥22years
• 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)

Sponsors & Collaborators

• Cala Health, Inc.: lead
• CVS Healthspire Life Sciences Solutions: collaborator

Study Sites (1)

Cala Health

San Mateo, California, 94404, United States

Location

Related Publications (1)

• Brillman S, Khemani P, Isaacson SH, Pahwa R, Deshpande R, Zraick V, Rajagopal A, Khosla D, Rosenbluth KH. Non-Invasive Transcutaneous Afferent Patterned Stimulation Therapy Offers Action Tremor Relief in Parkinson's Disease. Tremor Other Hyperkinet Mov (N Y). 2023 Aug 23;13:25. doi: 10.5334/tohm.762. eCollection 2023.

  PMID: 37637850 DERIVED

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 14, 2022
• Study Start: April 8, 2021
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: May 7, 2025

Record last verified: 2025-05

Locations

US (1)