A Pilot Study of AI-Controlled Transcutaneous Peripheral Nerve Stimulation for Essential Tremor.

Abstract

Background: Essential tremor (ET) can impact daily activities and quality of life. Transcutaneous peripheral nerve stimulation (TPNS) modulates the central tremor network and can reduce tremor. We report a pilot study with a novel TPNS device.

Methods: In this prospective, open-label study, ET patients underwent tremor evaluation and device fitting in the clinic, then used the system at home during waking hours for 7 to 10 days. Efficacy outcomes were the change from baseline to follow-up in The Essential Tremor Rating Assessment Scale (TETRAS) Performance Subscale (PS) for upper limbs, the TETRAS Activities of Daily Living (ADL) Subscale, the modified ADL (mADL) Score, and the Patient and Clinician Global Impression of Improvement questionnaires (PGI-I, CGI-I). Safety was also assessed.

Results: In the 17 patients with evaluable data, the dominant-hand PS improved from 14.1 at baseline to 11.4 at follow-up (p = 0.0002); the ADL and mADL improved from 29.9 to 20.7 and 34.8 to 24.8, respectively (both p < 0.001). Improvement was reported for 82% of patients on both the PGI-I and CGI-I. A skin reaction in one patient with adhesive allergy was the only adverse event.

Discussion: AI-controlled TPNS shows promise as a safe and effective treatment option for ET patients.

Highlights: In an uncontrolled pilot study, an AI-controlled transcutaneous peripheral nerve stimulation device was worn continuously during waking hours for 7 to 10 days by patients with essential tremor. Tremor statistically significantly decreased as measured by TETRAS subscales and Global Impression of Improvement questionnaires, and side effects were negligible.