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

NCT07774598 | Recruiting

• 1 other identifier: ET_TAPS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Essential Tremor

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

  3 months

Secondary Outcomes (8)

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

  Baseline; Day 1; 1 month; 3 months

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

  Baseline; 1 month; 3 months

• Change in Depression Severity (Hamilton Depression Rating Scale [HAMD])

  Baseline; 1 month; 3 months

• Change in Cognitive Function (Montreal Cognitive Assessment [MoCA])

  Baseline; 1 month; 3 months

• Change in Cognitive Function (Mini-Mental State Examination [MMSE])

  Baseline; 1 month; 3 months

Study Arms (1)

TAPS Treatment

EXPERIMENTAL

Device: Transcutaneous Afferent Patterned Stimulation

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.

TAPS Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

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

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Jun Liu, MD,PhD

CONTACT

021-86-64370045; jly0520@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2026
• First Posted: August 19, 2026
• Study Start: December 15, 2025
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): June 15, 2027
• Last Updated: August 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)