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 range22 Years
SexALL
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 …
What they're measuring
1
Tremor power changes from pre-stimulation to post-stimulation
Timeframe: baseline, pre-intervention and immediately after the intervention