An interventional study of Transcutaneous Afferent Patterned Stimulation in Essential Tremor, sponsored by Ruijin Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Ruijin Hospital · Not applicable, Interventional, and Treatment
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.
272 studies on the registry are indexed under Essential Tremor; 75 are open to participants now.
This study's planned enrollment of 50 is above the median of 25 across 189 interventional studies indexed under Essential Tremor.
Browse Essential Tremor studies →Ruijin Hospital is the lead sponsor of 679 studies on the registry; 387 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Transcutaneous Afferent Patterned Stimulation
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.
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
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.
Time frame: Baseline; 1 month; 3 months
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 months
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 months
Change in Cognitive Function (Mini-Mental State Examination [MMSE])
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.
Time frame: Baseline; 1 month; 3 months
Change in EEG Alpha Band Power
Change in electroencephalogram (EEG) alpha band power (8-12 Hz) from baseline to each post-treatment time point.
Time frame: Baseline; 1 month; 3 months
Change in Motor Evoked Potential (MEP) Amplitude
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.
Time frame: Baseline; 1 month; 3 months
Change in Functional Connectivity (fMRI)
Change in functional connectivity between predefined brain regions from baseline to post-treatment, assessed using functional magnetic resonance imaging (fMRI).
Time frame: Baseline; 3 months
Plan to share: No
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