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

Sponsor
Ruijin Hospital
Study ID
NCT07774598
Status
Recruiting
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Conditions

  • Essential Tremor

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcutaneous Afferent Patterned Stimulation — DEVICE
    A non-invasive, wearable neuromodulation device that delivers transcutaneous afferent patterned stimulation (TAPS) to modulate neural circuits associated with essential tremor. The device is applied according to the study protocol over the treatment period.

Study Details

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.

Key Dates

First listed
Aug 19, 2026
Start date
Dec 15, 2025
Status verified
Mar 2026
Primary completion
Mar 15, 2027
Completion
Jun 15, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TAPS Treatment

Primary Outcome Measure

Change in Tremor Severity (The Essential Tremor Rating Assessment Scale [TETRAS] Score) [ Time Frame: Baseline; Day 1; 1 month; 3 months ]

Central Contacts

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