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

Ruijin Hospital50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Essential Tremor

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in Tremor Severity (The Essential Tremor Rating Assessment Scale [TETRAS] Score)

Change in tremor severity from baseline to each post-treatment time point, assessed using the The Essential Tremor Rating Assessment Scale (TETRAS). The TETRAS score ranges from 0 to 64, with higher scores indicating more severe tremor.

Time frame: Baseline; Day 1; 1 month; 3 months

Incidence of Adverse Events

Incidence, type, and severity of adverse events occurring after treatment initiation. Adverse events will be graded according to standard criteria (e.g., CTCAE)

Time frame: 3 months

Secondary Outcomes

Change in Activities of Daily Living (Blessed Functional Activities of Daily Living [BF-ADL] Score)

Change in activities of daily living from baseline to each post-treatment time point, assessed using the Blessed Functional Activities of Daily Living Scale (BF-ADL). The BF-ADL score ranges from 0 to 17, with higher scores indicating greater functional impairment.

Time frame: Baseline; Day 1; 1 month; 3 months

Change in Anxiety Severity (Hamilton Anxiety Rating Scale [HAMA])

Change in anxiety severity from baseline to each post-treatment time point, assessed using the Hamilton Anxiety Rating Scale (HAMA). The HAMA score ranges from 0 to 56, with higher scores indicating more severe anxiety.