Non-Invasive Neuromodulation for Essential Tremor: Long-Term Safety and Effectiveness Study
17 augustus 2026 bijgewerkt door: Ruijin Hospital
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
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.
Studie Overzicht
Toestand
Werving
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
50
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Jun Liu, MD,PhD
- Telefoonnummer: 021-86-64370045
- E-mail: jly0520@hotmail.com
Studie Locaties
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Shanghai, China
- Werving
- Department of Neurology and Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai 200025
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Contact:
- Jun Liu, MD,PhD
- Telefoonnummer: 86-021-64370045
- E-mail: jly0520@hotmail.com
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-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: TAPS Treatment
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Tremor Severity (The Essential Tremor Rating Assessment Scale [TETRAS] Score)
Tijdsspanne: Baseline; Day 1; 1 month; 3 months
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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.
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Baseline; Day 1; 1 month; 3 months
|
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Incidence of Adverse Events
Tijdsspanne: 3 months
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Incidence, type, and severity of adverse events occurring after treatment initiation.
Adverse events will be graded according to standard criteria (e.g., CTCAE)
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3 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Activities of Daily Living (Blessed Functional Activities of Daily Living [BF-ADL] Score)
Tijdsspanne: 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.
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Baseline; Day 1; 1 month; 3 months
|
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Change in Anxiety Severity (Hamilton Anxiety Rating Scale [HAMA])
Tijdsspanne: 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.
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Baseline; 1 month; 3 months
|
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Change in Depression Severity (Hamilton Depression Rating Scale [HAMD])
Tijdsspanne: 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.
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Baseline; 1 month; 3 months
|
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Change in Cognitive Function (Montreal Cognitive Assessment [MoCA])
Tijdsspanne: Baseline; 1 month; 3 months
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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.
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Baseline; 1 month; 3 months
|
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Change in Cognitive Function (Mini-Mental State Examination [MMSE])
Tijdsspanne: 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.
|
Baseline; 1 month; 3 months
|
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Change in EEG Alpha Band Power
Tijdsspanne: Baseline; 1 month; 3 months
|
Change in electroencephalogram (EEG) alpha band power (8-12 Hz) from baseline to each post-treatment time point.
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Baseline; 1 month; 3 months
|
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Change in Motor Evoked Potential (MEP) Amplitude
Tijdsspanne: 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.
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Baseline; 1 month; 3 months
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Change in Functional Connectivity (fMRI)
Tijdsspanne: Baseline; 3 months
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Change in functional connectivity between predefined brain regions from baseline to post-treatment, assessed using functional magnetic resonance imaging (fMRI).
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Baseline; 3 months
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
15 december 2025
Primaire voltooiing (Geschat)
15 maart 2027
Studie voltooiing (Geschat)
15 juni 2027
Studieregistratiedata
Eerst ingediend
22 maart 2026
Eerst ingediend dat voldeed aan de QC-criteria
17 augustus 2026
Eerst geplaatst (Werkelijk)
19 augustus 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
19 augustus 2026
Laatste update ingediend die voldeed aan QC-criteria
17 augustus 2026
Laatst geverifieerd
1 maart 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- ET_TAPS
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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