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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRuijin Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Transcutaneous Afferent Patterned Stimulation

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators