Objective: To determine the feasibility of delivery, clinical effectiveness, healthcare resource utilization (HCRU) and costs of transcutaneous afferent patterned stimulation (TAPS) therapy for the treatment of hand tremor among adult patients with essential tremor (ET).

Background: ET is the most common movement disorder, often impairing patients’ ability to perform activities of daily living, mental health, and quality of life. TAPS therapy is delivered through a novel non-invasive wrist-worn neuromodulation device that stimulates the ventral immediate nucleus of the thalamus, a key relay point in the central tremor network, and the target of deep brain stimulation. This study aims to assess the clinical effectiveness and economic impact of TAPS in ET.

Method: This TAPS randomized clinical trial (TRCT), divided into two phases, will enroll 300 ET patients from Aetna’s commercially insured and Medicare Advantage populations. Patients will be randomized to either a standard of care (SOC) arm or intervention with TAPS therapy arm (1 to 1 ratio). Phase one lasts one month, during which, patients in the treatment arm will use TAPS therapy at home and patients in the SOC arm will receive usual care. The pre-specified primary endpoint is improvement in the tremor power detected by an accelerometer on the device over the 1st month of the study. After one month, patients in the SOC arm will cross over to the treatment arm. During the second phase, from months 2-12, all patients in the treatment arm will be asked to use TAPS therapy as needed. The secondary endpoints include patient-rated Bain & Findley activities of daily living dominant hand scores (online survey), HCRU (including prescriptions), costs (claims data), and patient preference (online exit survey). Device usage data (recorded on the TAPS device) will be used to assess the device adherence and compliance.

Results: IRB approval and informed consent were obtained for the study protocol; online engagement platform content and outreach materials were approved, and screening and recruitment have begun. Ninety-nine ET patients are already enrolled in the trial and phase one results should be available by early 2023.

Conclusion: TRCT will evaluate the feasibility of delivery, clinical effectiveness, and economic impact of TAPS for the treatment of hand tremor among adult patients with ET.

« Back to 2022 International Congress

MDS Abstracts - https://www.mdsabstracts.org/abstract/clinical-effectiveness-and-economic-impact-of-transcutaneous-afferent-patterned-stimulation-therapy-for-essential-tremor-in-a-real-world-setting-protocol-for-a-pragmatic-trial/