Symptomatic Relief of Action Tremor With Cala Trio Using Trio+ Bands

NCT05480215 | Completed FDA Device

• 1 other identifier: ET-22
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Demonstrate safety and effectiveness of symptomatic action tremor relief in the treated hand following stimulation with the Cala Trio System using the Trio+ bands as compared to the Trio bands in adults with Essential Tremor (ET) and/or Parkinson's Disease (PD) over 2 weeks.

Conditions

Essential Tremor; Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Tremor power changes from pre-stimulation to post-stimulation

  Tremor improvement was measured by Tremor Power Improvement Ratio (TPIR) using kinematic data collected by the device. The TPIR was calculated as pre-stimulation power divided by post-stimulation power, which was computed from device-collected accelerometer data

  baseline, pre-intervention and immediately after the intervention

Secondary Outcomes (3)

• Change in TETRAS from pre-stimulation to post- stimulation within each visit

  baseline, pre-intervention and immediately after the intervention

• Change in UPDRS Part III from pre-stimulation to post- stimulation within each visit

  baseline, pre-intervention and immediately after the intervention

• Change in BF-ADL

  baseline, pre-intervention and immediately after the intervention

Study Arms (2)

Experimental: TAPS delivered by Cala device with Trio band

EXPERIMENTAL

Two 40-minute TAPS sessions daily for 14 days

Device: Cala Device

Experimental: TAPS delivered by Cala device with Trio+ band

EXPERIMENTAL

Two 40-minute TAPS sessions daily for 14 days

Device: Cala Device

Interventions

Cala Device DEVICE

transcutaneous afferent patterned stimulation (TAPS)

Experimental: TAPS delivered by Cala device with Trio band; Experimental: TAPS delivered by Cala device with Trio+ band

Eligibility Criteria

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

You may qualify if:

• Must be ≥22 years of age
• Competent and willing to provide written, informed consent to participate in the study
• Willing to comply with study protocol requirements
• For subjects with Essential Tremor:
• A diagnosis of essential tremor
• A tremor severity score of 2 or above in the dominant hand/arm as measured by one of the TETRAS upper limb postural tremor items
• No significant alcohol intake within 8 hours prior to study visits
• For subjects with Parkinson's Disease:
• Dominant hand/arm exhibiting postural tremor ≥ 2 (while in the off state) as assessed by the MDS-UPDRS postural tremor score
• Stable dose of Parkinson's disease medications, if applicable, for 30 days prior to study entry

You may not qualify if:

• Implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator
• Suspected or diagnosed epilepsy or other seizure disorder
• Any skin condition at the stimulation site that in the investigator's opinion should preclude participation in this study
• Diagnosed with peripheral neuropathy affecting the tested upper extremity
• Presence of any other neurodegenerative disease other than essential tremor or Parkinson's Disease
• Subjects unable to communicate with the investigator and staff
• Any health condition or concomitant medication that in the investigator's opinion should preclude participation in this study
• Pregnancy or anticipated pregnancy during the course of the study
• Botulinum toxin injection for hand tremor within 6 months prior to study enrollment
• Are participating or have participated in another interventional clinical trial in the last 30 days which may confound the results of this study, unless approved by the Sponsor

Sponsors & Collaborators

• Cala Health, Inc.: lead

Study Sites (1)

Cala Clinic

San Mateo, California, 94404, United States

Location

MeSH Terms

Conditions

Essential Tremor; Parkinson Disease

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Synucleinopathies; Neurodegenerative Diseases

Study Design

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

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: July 29, 2022
• Study Start: October 7, 2021
• Primary Completion: December 16, 2021
• Study Completion: December 16, 2021
• Last Updated: July 29, 2022

Record last verified: 2022-07

Locations

US (1)