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NCT Number: NCT07774598

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

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.

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Key information

Conditions

Essential Tremor Central Nervous System Diseases Movement Disorders Nervous System Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Shanghai, China

Location status: Recruiting

Location contact

Jun Liu, MD,PhD

CONTACT

[email protected]

86-021-64370045

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

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

    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.

  2. Incidence of Adverse Events

    Time frame: 3 months

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

Secondary outcomes

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

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

    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.

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

    Time frame: Baseline; 1 month; 3 months

    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.

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

    Time frame: Baseline; 1 month; 3 months

    Change in depression severity from baseline to each post-treatment time point, assessed using the Hamilton Depression Rating Scale (HAMD). The HAMD score ranges from 0 to 52, with higher scores indicating more severe depression.

  4. Change in Cognitive Function (Montreal Cognitive Assessment [MoCA])

    Time frame: Baseline; 1 month; 3 months

    Change in cognitive function from baseline to each post-treatment time point, assessed using the Montreal Cognitive Assessment (MoCA). The MoCA score ranges from 0 to 30, with higher scores indicating better cognitive function.

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

    Time frame: Baseline; 1 month; 3 months

    Change in cognitive function from baseline to each post-treatment time point, assessed using the Mini-Mental State Examination (MMSE). The MMSE score ranges from 0 to 30, with higher scores indicating better cognitive function.

  6. Change in EEG Alpha Band Power

    Time frame: Baseline; 1 month; 3 months

    Change in electroencephalogram (EEG) alpha band power (8-12 Hz) from baseline to each post-treatment time point.

  7. Change in Motor Evoked Potential (MEP) Amplitude

    Time frame: Baseline; 1 month; 3 months

    Change in motor evoked potential (MEP) amplitude from baseline to each post-treatment time point, measured using transcranial magnetic stimulation. MEP amplitude is measured in millivolts (mV), with higher values indicating greater corticospinal excitability.

  8. Change in Functional Connectivity (fMRI)

    Time frame: Baseline; 3 months

    Change in functional connectivity between predefined brain regions from baseline to post-treatment, assessed using functional magnetic resonance imaging (fMRI).

Study contacts

Contact information is provided by the study sponsor or research team.

Jun Liu, MD,PhD

CONTACT

[email protected]

021-86-64370045

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

A Prospective, Single-Center, Single-Arm, Open-Label Clinical Study Evaluating the Long-Term Safety and Efficacy of Transcutaneous Afferent Patterned Stimulation (TAPS) in Patients With Essential Tremor

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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