Last reviewed · How we verify
NCT05540626
RWE Study Utilizing the Cala Trio Device in Patients With Essential Tremor
NA trial testing Cala Trio in Essential Tremor in 276 participants. Completed in 1 March 2024.
1 March 2024
Quick facts
| Lead sponsor | Cala Health, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 276 |
| Start date | 8 April 2021 |
| Primary completion | 1 March 2024 |
| Estimated completion | 1 March 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Cala Trio
Conditions studied
- Essential Tremor — all drugs for Essential Tremor →
Sponsor
Cala Health, Inc. — full company profile →
Who can join
22 and older, any sex, with Essential Tremor. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The study objective is to evaluate hand tremor relief in the treated hand following stimulation with the Cala Trio Device in adults with essential tremor, and healthcare resource utilization and total healthcare costs over a 12-month period.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Comparative Effectiveness of Transcutaneous Afferent Patterned Stimulation Therapy for Essential Tremor: A Randomized Pragmatic Clinical Trial.
Dai D, Fernandes J, Kim H, Coetzer H. · · 2023 · cited 12× · PMID 37869579 · DOI 10.5334/tohm.798 -
Non-Invasive Transcutaneous Afferent Patterned Stimulation Therapy Offers Action Tremor Relief in Parkinson's Disease.
Brillman S, Khemani P, Isaacson SH, Pahwa R, et al · · 2023 · cited 3× · PMID 37637850 · DOI 10.5334/tohm.762 -
Poster Abstracts - Academy of Managed Care Pharmacy 2023
· 2023
Verify or expand the search:
- PubMed search for NCT05540626
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Essential Tremor
Currently open trials in the same condition.
- NCT07417280 — LIFUS For Neurological Disorders · NA · recruiting
- NCT07172295 — Modulate Tremor Severity With Low-intensity Focused Ultrasound Stimulation Targeting the Deep Nucleus of Patients With R · NA · recruiting
- NCT07016425 — Temporal Interference for Essential Tremor · NA · recruiting
- NCT07049003 — Deep Brain Stimulation of the Deep Cerebellar Nuclei for Refractory Tremor · Phase 1 · recruiting
- NCT06428526 — Impact of Sensory Electrical Stimulation on Sensation and Tremor · NA · active not recruiting
Other Cala Health, Inc. trials
Trials by the same sponsor.
- NCT05662059 — Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) Study in Ulcerative Colitis · NA · unknown
- NCT05480215 — Symptomatic Relief of Action Tremor With Cala Trio Using Trio+ Bands · NA · completed
- NCT05012579 — Transcutaneous Afferent Patterned Stimulation (TAPS) for Reduction of Parkinson's Disease (PD) Related Action Tremor · NA · completed
- NCT03597100 — Prospective Study for Symptomatic Relief of ET With Cala Therapy · NA · completed
- NCT03152136 — A Pilot Study of the Cala ONE Device for Essential Tremor · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05540626 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cala Health, Inc.
- Last refreshed: 7 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05540626.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing