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

RecruitingNAAges 18 Years - 75 YearsAllRuijin Hospital
NCT07774598 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 de

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📋 Eligibility rules (as published)
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
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What it tests

  • Transcutaneous Afferent Patterned Stimulation
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Where

1 site
Department of Neurology and Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai 200025
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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