Symptomatic Relief of Action Tremor With Cala Trio Using Trio+ Bands (NCT05480215) | Clinical Trial Compass
CompletedNot Applicable
Symptomatic Relief of Action Tremor With Cala Trio Using Trio+ Bands
United States20 participantsStarted 2021-10-07
Plain-language 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.
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Tremor power changes from pre-stimulation to post-stimulation
Timeframe: baseline, pre-intervention and immediately after the intervention