Non-Invasive Neuromodulation for Essential Tremor: Long-Term Safety and Effectiveness Study
17. august 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
50
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Jun Liu, MD,PhD
- Telefonnummer: 021-86-64370045
- E-post: jly0520@hotmail.com
Studiesteder
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Shanghai, Kina
- Rekruttering
- Department of Neurology and Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai 200025
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Ta kontakt med:
- Jun Liu, MD,PhD
- Telefonnummer: 86-021-64370045
- E-post: jly0520@hotmail.com
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Tremor Severity (The Essential Tremor Rating Assessment Scale [TETRAS] Score)
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Activities of Daily Living (Blessed Functional Activities of Daily Living [BF-ADL] Score)
Tidsramme: Baseline; Day 1; 1 month; 3 months
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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])
Tidsramme: Baseline; 1 month; 3 months
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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])
Tidsramme: Baseline; 1 month; 3 months
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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])
Tidsramme: 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])
Tidsramme: Baseline; 1 month; 3 months
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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.
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Baseline; 1 month; 3 months
|
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Change in EEG Alpha Band Power
Tidsramme: Baseline; 1 month; 3 months
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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
Tidsramme: Baseline; 1 month; 3 months
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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)
Tidsramme: 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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Samarbeidspartnere og etterforskere
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Sponsor
Studierekorddatoer
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Studer hoveddatoer
Studiestart (Faktiske)
15. desember 2025
Primær fullføring (Antatt)
15. mars 2027
Studiet fullført (Antatt)
15. juni 2027
Datoer for studieregistrering
Først innsendt
22. mars 2026
Først innsendt som oppfylte QC-kriteriene
17. august 2026
Først lagt ut (Faktiske)
19. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
17. august 2026
Sist bekreftet
1. mars 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ET_TAPS
Plan for individuelle deltakerdata (IPD)
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NEI
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Nei
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