Back to resultsSymptomatic Relief of Action Tremor With Cala Trio Using Trio+ Bands
Primary Purpose
Essential Tremor, Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cala Device
Sponsored by
About this trial
This is an interventional treatment trial for Essential Tremor
Eligibility Criteria
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
Sites / Locations
- Cala Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Experimental: TAPS delivered by Cala device with Trio band
Experimental: TAPS delivered by Cala device with Trio+ band
Arm Description
Two 40-minute TAPS sessions daily for 14 days
Two 40-minute TAPS sessions daily for 14 days
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change in TETRAS from pre-stimulation to post- stimulation within each visit
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
Change in UPDRS Part III from pre-stimulation to post- stimulation within each visit
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
Change in BF-ADL
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05480215
Brief Title
Symptomatic Relief of Action Tremor With Cala Trio Using Trio+ Bands
Official Title
Prospective Study for Symptomatic Relief of Action Tremor With Cala Trio Using Trio+ Bands
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 7, 2021 (Actual)
Primary Completion Date
December 16, 2021 (Actual)
Study Completion Date
December 16, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cala Health, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor, Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental: TAPS delivered by Cala device with Trio band
Arm Type
Experimental
Arm Description
Two 40-minute TAPS sessions daily for 14 days
Arm Title
Experimental: TAPS delivered by Cala device with Trio+ band
Arm Type
Experimental
Arm Description
Two 40-minute TAPS sessions daily for 14 days
Intervention Type
Device
Intervention Name(s)
Cala Device
Intervention Description
transcutaneous afferent patterned stimulation (TAPS)
Primary Outcome Measure Information:
Title
Tremor power changes from pre-stimulation to post-stimulation
Description
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
Time Frame
baseline, pre-intervention and immediately after the intervention
Secondary Outcome Measure Information:
Title
Change in TETRAS from pre-stimulation to post- stimulation within each visit
Description
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
Time Frame
baseline, pre-intervention and immediately after the intervention
Title
Change in UPDRS Part III from pre-stimulation to post- stimulation within each visit
Description
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
Time Frame
baseline, pre-intervention and immediately after the intervention
Title
Change in BF-ADL
Description
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)
Time Frame
baseline, pre-intervention and immediately after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Cala Clinic
City
San Mateo
State/Province
California
ZIP/Postal Code
94404
Country
United States
12. IPD Sharing Statement
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Symptomatic Relief of Action Tremor With Cala Trio Using Trio+ Bands
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