Clinical Research Summary
Our goal is to give you the information needed to help you understand and manage your tremors.
We want to make sure that all people living with essential tremor can understand the research we fund and conduct. Tremor reduction of 50% is comparable to first-line pharmacotherapies: propranolol and primidone, but without their side effect profile.1,2
Some patients had tremor reduction as large as 55-90%, similar to surgical outcomes, but without the risk of permanent side effects.1,3
What is PROSPECT?
Cala Heath sponsored the largest therapeutic clinical research study ever conducted, PROSPECT, PROspective study for SymPtomatic relief of Essential tremor with Cala Therapy.
Movement Disorder Centers in the US participated
263 patients aged 23 to 89, average 70. 52% of patients were female and 48% male.
Average years duration of essential tremor symptoms
Used Cala Therapy for 3 months at home, 2 times per day
What did we learn from PROSPECT?
Of patients had a 50% reduction in tremor power*
Average duration of a meaningful, short-term tremor reduction with a single 40-minute session4
Cala Therapy is a safe treatment for patients with essential tremor
*Tremor power is a calculation of amplitude and frequency. Tremor power decreases with lower amplitude motions and lower frequency motions.1,2
Do all patients respond to Cala Therapy?
In therapy sessions conducted at-home, motion sensors on the device showed4:
Per-patient tremor power reduction demonstrated in home-use therapy sessions
improved by 50%
improved by 70%
How much relief can Cala Therapy provide?
With twice daily usage of at-home use4...
of patients improved from ‘Severe’ or ‘Moderate’ tremor at the beginning of the study to ‘Mild’ or ’Slight’ tremor as measured by physicians.
of patients improved from ‘Severe’ or ‘Moderate’ tremor at the beginning of the study to ‘Mild’ tremor as reported by patients.
With a single therapy session observed in-clinic, tremor improved significantly.
Tremor rated after the therapy session (Post) was significantly better* than tremor rated before (Pre); a lower score represents less tremor. This improvement was demonstrated at clinic visits on three separate occasions:
- at the beginning of the study
- after 1 month of at-home use
- after 3 months of at-home use
TETRAS Improvement at Clinic Visits
ADL Improvement at Clinic Visits
* p < 0.0001
How safe is Cala Therapy?
- There were no device-related serious adverse events.
- Device-related adverse events occurred in 18% of patients (primarily skin irritation, sore/lesions, discomfort or burns that resolved without medical intervention)
- All resolved either without intervention, with decreasing stimulation level, with topical ointment, or discontinuing therapy until resolved
1 Zesiewicz T a, Elble R, Louis ED, et al. Practice parameter: therapies for essential tremor: report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2005;64:2008–2020. 10.1212/01.WNL.0000163769.28552.CD.
2 Hedera P, Cibulčík F, Davis TL. Pharmacotherapy of Essential Tremor. J Cent Nerv Syst Dis. SAGE Publications; 2013;5:JCNSD.S6561.
3 Sinai A, Nassar M, Eran A, et al. Magnetic resonance-guided focused ultrasound thalamotomy for essential tremor: a 5-year single-center experience. J Neurosurg. Epub 2019 Jul 5.:1–8. 10.3171/2019.3.JNS19466.
4 Isaacson, et al. Study Design, Baseline Demographics, and Interim Results from the Prospective Study for Symptomatic Relief of Essential Tremor with Cala Therapy (PROSPECT) Trial, International Congress of Parkinson’s Disease and Movement Disorders 2019 Late-Breaking Abstracts.