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Behavioural Intervention

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

N/A
Waitlist Available
Research Sponsored by Cala Health, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, pre-intervention and immediately after the intervention
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Dementia
  • Essential Tremor
  • Parkinson's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, pre-intervention and immediately after the intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, pre-intervention and immediately after the intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Tremor power changes from pre-stimulation to post-stimulation
Secondary study objectives
Change in BF-ADL
Change in TETRAS from pre-stimulation to post- stimulation within each visit
Change in UPDRS Part III from pre-stimulation to post- stimulation within each visit

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Experimental: TAPS delivered by Cala device with Trio+ bandExperimental Treatment1 Intervention
Two 40-minute TAPS sessions daily for 14 days
Group II: Experimental: TAPS delivered by Cala device with Trio bandExperimental Treatment1 Intervention
Two 40-minute TAPS sessions daily for 14 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cala Device
2021
N/A
~60

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Who is running the clinical trial?

Cala Health, Inc.Lead Sponsor
8 Previous Clinical Trials
838 Total Patients Enrolled
~5 spots leftby Dec 2025
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