eClinical Technology and Industy News

Cala TAPS Therapy for Essential Tremor Patients Improves Outcomes in a New Randomized Controlled Trial

Excerpt from the Press Release:

SAN MATEO, Calif.–(BUSINESS WIRE)–Cala, the bioelectronic medicine leader setting a new standard of care for chronic disease, today announced meeting the primary endpoint on an interim analysis of a prospective, randomized, controlled study. This study, “RWE Study Utilizing the Cala Trio Device in Patients With Essential Tremor” (clinicaltrials.gov NCT05540626), demonstrated that adding TAPS therapy to the patient’s care plan improved outcomes.

The study met its primary endpoint, demonstrating patients adding TAPS therapy had significantly reduced (i.e. improved) tremor power than patients not adding TAPS therapy to their care plan (p<.0001) in the first 261 patients who have completed the randomized portion of the study. 84% of patients experienced tremor reduction and 43% of patients experienced greater than 2-fold tremor improvement (i.e. 50% tremor reduction) after a single month of therapy (p=0.0047). Patients adding TAPS therapy also had significantly greater improvement in Bain & Findley Activities of Daily Living (ADL). Additionally, patients using TAPS therapy experienced significantly improved tremor power before and after TAPS (p<0.0001) and significantly reduced baseline tremor only with 1 month of repeated use (p=0.0018).

These findings were presented at the Academy of Managed Care Pharmacy (AMCP) on March 23, 2023, which recognized the abstract with a Bronze ribbon award for its relevance, originality, quality and clarity.

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