Non-Invasive Neuromodulation for Essential Tremor: Long-Term Safety and Effectiveness Study

A Prospective, Single-Center, Single-Arm, Open-Label Clinical Study Evaluating the Long-Term Safety and Efficacy of Transcutaneous Afferent Patterned Stimulation (TAPS) in Patients With Essential Tremor

This is a prospective, single-center, single-arm, open-label clinical study designed to evaluate the long-term efficacy and safety of non-invasive neuromodulation using transcutaneous afferent patterned stimulation (TAPS) in patients with essential tremor (ET).

Essential tremor is a common movement disorder that can significantly impair daily functioning and quality of life. Pharmacological treatments are often limited by suboptimal efficacy or adverse effects, highlighting the need for alternative therapeutic approaches.

In this study, eligible participants with essential tremor will receive TAPS treatment over a defined follow-up period. Clinical outcomes, including tremor severity, functional performance, and patient-reported outcomes, will be assessed longitudinally to evaluate treatment effectiveness. Safety will be monitored throughout the study by recording adverse events and device-related complications.

The results of this study aim to provide clinical evidence regarding the long-term therapeutic potential and safety profile of TAPS as a non-invasive neuromodulation strategy for essential tremor.

Inclusion Criteria:

• Adults aged ≥18 and <75 years
• Clinical diagnosis of essential tremor (ET), characterized by postural and/or kinetic tremor, primarily affecting one or both upper limbs, with or without involvement of other body regions (e.g., head, voice, or lower limbs)
• At least one major hand task score ≥2 on the TETRAS (The Essential Tremor Rating Assessment Scale), and a score ≥3 on the Bain & Findley Activities of Daily Living (BF-ADL) scale
• Able and willing to provide written informed consent

Exclusion Criteria:

• Presence of implanted electronic medical devices (e.g., deep brain stimulator or cardiac pacemaker)
• History of thalamotomy or other neurosurgical procedures for tremor
• History of epilepsy
• Current treatment with botulinum toxin for upper limb tremor
• Skin lesions on the upper limb at the stimulation site (e.g., tumors, hemangiomas)
• Neurological disorders affecting the upper limbs
• Known allergy to device materials (e.g., silicone, cotton textiles)
• Pregnant women
• Intake of caffeine or excessive alcohol within 8 hours prior to enrollment
• Severe cardiovascular or cerebrovascular diseases, or other significant neurological disorders
• Inability to comply with study procedures or follow-up