Non-Invasive Neuromodulation for Essential Tremor: Long-Term Safety and Effectiveness Study
ConditionEssential Tremor
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRuijin Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Transcutaneous Afferent Patterned Stimulation
DeviceA 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: TAPS TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 months2
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 monthsSecondary outcomes
1
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 months2
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.
Time frame
Baseline; 1 month; 3 months3
Change in Depression Severity (Hamilton Depression Rating Scale [HAMD])
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.
Time frame
Baseline; 1 month; 3 months4
Change in Cognitive Function (Montreal Cognitive Assessment [MoCA])
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.
Time frame
Baseline; 1 month; 3 monthsSponsors and contacts
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Source ClinicalTrials.gov