Non-Invasive Nerve Stimulation for Essential Tremor: Long-Term Safety and Effectiveness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center, single-arm, open-label study evaluating the long-term safety and effectiveness of transcutaneous afferent patterned stimulation (TAPS) for essential tremor. Eligible adults will receive TAPS over a defined follow-up period, with outcomes tracked over time to assess tremor severity, functional performance, and patient-reported impact on daily life. Safety will be monitored through adverse events and device-related complications. The trial aims to provide clinical evidence on whether long-term TAPS can improve symptoms and quality of life in ET patients. Findings may inform future use of non-invasive neuromodulation as an alternative or adjunct therapy.

Why it matters

Who can join: the full rules

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

Where it's running

• Department of Neurology and Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai 200025
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Jun Liu, MD,PhD
• Email: jly0520@hotmail.com
• Phone: 021-86-64370045

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.