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

Sponsor
Cala Health, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT05480215
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
2.3
Actual Duration (Months)
8.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Cala Device
 N/A

Detailed Description

20 patients with (13 with ET and 7 with PD) with at least mild postural tremor were enrolled in a prospective, single-center, two-arm, crossover study that took place over the course of four weeks. TAPS devices were shipped to patients to run the study remotely. In the first arm of the study, subjects received TAPS treatment using the original. Cala Trio band for two weeks. Followed by a wash-out period (> 24 hours), subjects entered the second arm and received TAPS using the Trio+ band for an additional two weeks. Unsupervised motion assessments were captured at home, and at the beginning and end of the four weeks by telemedicine.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective Study for Symptomatic Relief of Action Tremor With Cala Trio Using Trio+ Bands
Actual Study Start Date :
Oct 7, 2021
Actual Primary Completion Date :
Dec 16, 2021
Actual Study Completion Date :
Dec 16, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental: TAPS delivered by Cala device with Trio band

Two 40-minute TAPS sessions daily for 14 days

Device: Cala Device
transcutaneous afferent patterned stimulation (TAPS)
Experimental: Experimental: TAPS delivered by Cala device with Trio+ band

Two 40-minute TAPS sessions daily for 14 days

Device: Cala Device
transcutaneous afferent patterned stimulation (TAPS)

Outcome Measures

Primary Outcome Measures

  1. Tremor power changes from pre-stimulation to post-stimulation [baseline, pre-intervention and immediately after the intervention]

    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

Secondary Outcome Measures

  1. Change in TETRAS from pre-stimulation to post- stimulation within each visit [baseline, pre-intervention and immediately after the intervention]

    For subjects with Essential Tremor only: Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) subset score, relevant to the stimulated upper limb, change from pre-stimulation to post- stimulation within each visit

  2. Change in UPDRS Part III from pre-stimulation to post- stimulation within each visit [baseline, pre-intervention and immediately after the intervention]

    For subjects with Parkinson's Disease only: Modified Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS) subset score, change from pre- stimulation to post-stimulation within each visit

  3. Change in BF-ADL [baseline, pre-intervention and immediately after the intervention]

    Change in the Bain & Findley activities of daily living (BF-ADL) score from pre- to post-stimulation at each of the two study visits associated with the Trio and Trio+ bands (four study visits total)

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cala Clinic San Mateo California United States 94404

Sponsors and Collaborators

  • Cala Health, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cala Health, Inc.
ClinicalTrials.gov Identifier:
NCT05480215
Other Study ID Numbers:
  • ET-22
First Posted:
Jul 29, 2022
Last Update Posted:
Jul 29, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Parkinson Disease
Tremor
Essential Tremor

Study Results

No Results Posted as of Jul 29, 2022