- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05480215
Symptomatic Relief of Action Tremor With Cala Trio Using Trio+ Bands
July 27, 2022 updated by: Cala Health, Inc.
Prospective Study for Symptomatic Relief of Action Tremor With Cala Trio Using Trio+ Bands
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Mateo, California, United States, 94404
- Cala Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental: TAPS delivered by Cala device with Trio band
Two 40-minute TAPS sessions daily for 14 days
|
transcutaneous afferent patterned stimulation (TAPS)
|
Experimental: Experimental: TAPS delivered by Cala device with Trio+ band
Two 40-minute TAPS sessions daily for 14 days
|
transcutaneous afferent patterned stimulation (TAPS)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tremor power changes from pre-stimulation to post-stimulation
Time Frame: 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
|
baseline, pre-intervention and immediately after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in TETRAS from pre-stimulation to post- stimulation within each visit
Time Frame: 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
|
baseline, pre-intervention and immediately after the intervention
|
Change in UPDRS Part III from pre-stimulation to post- stimulation within each visit
Time Frame: 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
|
baseline, pre-intervention and immediately after the intervention
|
Change in BF-ADL
Time Frame: 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)
|
baseline, pre-intervention and immediately after the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 7, 2021
Primary Completion (Actual)
December 16, 2021
Study Completion (Actual)
December 16, 2021
Study Registration Dates
First Submitted
July 26, 2022
First Submitted That Met QC Criteria
July 27, 2022
First Posted (Actual)
July 29, 2022
Study Record Updates
Last Update Posted (Actual)
July 29, 2022
Last Update Submitted That Met QC Criteria
July 27, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ET-22
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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