Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Immediate Effects of External Trigeminal Nerve Stimulation on Motor Dysfunction in Parkinson's Disease

14 giugno 2026 aggiornato da: Zhengli Di

Parkinson's disease (PD), the most common movement disorder, is characterized by motor symptoms including tremor, rigidity, bradykinesia, and postural instability. These symptoms substantially impair quality of life and increase the risk of falls, disability, and accidental injury, representing a major therapeutic challenge.

External trigeminal nerve stimulation (eTNS), a non-invasive neuromodulation technique, has shown promising potential in PD and other movement disorders. A clinical study published in 2017 suggested that trigeminal nerve stimulation may contribute to the alleviation of motor symptoms in patients with PD. In 2023, the U.S. Food and Drug Administration cleared the Portable Neuromodulation Stimulator (PoNS) as an adjunctive treatment for gait impairment caused by multiple sclerosis; the lingual nerve is a branch of the mandibular division of the trigeminal nerve. In the same year, experimental evidence showed that trigeminal nerve stimulation could activate intracranial dopaminergic neurons and modulate dopamine release in mice. These findings suggest substantial potential for eTNS in modulating motor dysfunction in PD, although high-level clinical evidence remains lacking.

This randomized, within-subject study will evaluate the immediate effects of eTNS at different stimulation frequencies on motor dysfunction in patients with PD. Gait parameters will be quantitatively assessed using the IDEEA gait system, together with the MDS-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS Part III), Tinetti Gait Scale, and Hoehn and Yahr Scale.

This within-subject study comprises three 20-min stimulation conditions: 120-Hz eTNS, 40-Hz eTNS, and sham stimulation. Each patient with Parkinson's disease will complete all conditions in a single session in randomized order. Instrumented gait analysis, together with motor and gait rating scales, will be used to quantify immediate post-stimulation changes in gait and motor function relative to baseline.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

30

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
    • Shaanxi
      • Xi'an, Shaanxi, Cina, 710000
        • Xi'an Central Hospital, Department of Neurology
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  1. Patients with idiopathic Parkinson's disease diagnosed by two neurologists, according to the Chinese diagnostic criteria for Parkinson's disease formulated in 2020 by the Chinese Parkinson's Disease and Movement Disorders Society based on the MDS Clinical Diagnostic Criteria for Parkinson's disease.
  2. Hoehn and Yahr stage 1-5 in the medication ON state.
  3. Mini-Mental State Examination (MMSE) score >24.
  4. Stable antiparkinsonian medication for at least 1 month before the trial.
  5. No history of orthopedic or musculoskeletal disorders, and no other conditions that may affect balance or gait, such as ophthalmologic disorders.
  6. No history of epilepsy, intracranial tumors, or other neurological disorders; no severe psychiatric disorders, such as schizophrenia; and no long-term use of antipsychotic medications.
  7. Age between 40 and 80 years.
  8. Ability to cooperate with all assessments and eTNS treatment, and provision of written informed consent.

Exclusion Criteria:

  1. Secondary parkinsonism or atypical parkinsonian syndromes.
  2. Current use of anticholinergic medications.
  3. Contraindications to non-invasive electrical neuromodulation.
  4. Previous eTNS treatment within the past 6 months.
  5. Severe neurological, renal, cardiovascular, hepatic, or other major systemic diseases.
  6. Inability to complete clinical assessments or refusal to provide written informed consent.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 40Hz-eTNS
40-Hz eTNS: frequency,40Hz; pulse width, 250 μs; duty cycle, 30 s on/30 s off; total stimulation duration, 20 min.
Dispositivo: external Trigeminal Nerve Stimulation, eTNS
The experiment will be conducted in the MED-ON state, consistently 1-2 h after administration of antiparkinsonian medication. Baseline gait and motor function assessments will first be performed, followed by three randomized eTNS stimulation sessions. Gait will be assessed after each stimulation session, and motor function scales will be reassessed after completion of all experimental conditions.
Altri nomi:
  • Anti-parkinson's disease drugs
Comparatore attivo: 120Hz-eTNS
120-Hz eTNS: frequency,120Hz; pulse width, 250 μs; duty cycle, 30 s on/30 s off; total stimulation duration, 20 min.
Dispositivo: external Trigeminal Nerve Stimulation, eTNS
The experiment will be conducted in the MED-ON state, consistently 1-2 h after administration of antiparkinsonian medication. Baseline gait and motor function assessments will first be performed, followed by three randomized eTNS stimulation sessions. Gait will be assessed after each stimulation session, and motor function scales will be reassessed after completion of all experimental conditions.
Altri nomi:
  • Anti-parkinson's disease drugs
Comparatore fittizio: sham-eTNS
Sham eTNS used a double-ramp paradigm with the same parameters as the 120-Hz condition(frequency,120Hz; pulse width, 250 μs; total stimulation duration, 20 min.), but current was delivered only at stimulation onset (0-15 s) and midway through the session (15 s at 10 min).
Dispositivo: external Trigeminal Nerve Stimulation, eTNS
The experiment will be conducted in the MED-ON state, consistently 1-2 h after administration of antiparkinsonian medication. Baseline gait and motor function assessments will first be performed, followed by three randomized eTNS stimulation sessions. Gait will be assessed after each stimulation session, and motor function scales will be reassessed after completion of all experimental conditions.
Altri nomi:
  • Anti-parkinson's disease drugs

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Dual-Task Cost (DTC)
Lasso di tempo: DTC will be assessed at baseline and after each randomized eTNS condition during walking tasks, using the IDEEA inertial sensor based gait analysis system.
This is a within-subject study. Instrumented gait parameters and clinical rating scales will be assessed at baseline, followed by eTNS stimulation in randomized order under the 120-Hz, 40-Hz, and sham conditions. After each eTNS condition, instrumented gait parameters will be collected during walking tasks. Clinical rating scales will be additionally assessed after the final stimulation condition.Dual-task cost will be calculated as: [(single-task gait speed - dual-task gait speed) / single-task gait speed] × 100%.DTC reflects the reduction in walking performance under dual-task conditions relative to single-task conditions. A decrease in DTC after eTNS indicates reduced dual-task interference during walking, suggesting that eTNS may reduce dual-task gait cost in patients with PD.
DTC will be assessed at baseline and after each randomized eTNS condition during walking tasks, using the IDEEA inertial sensor based gait analysis system.
Mean Gait Speed（m/s）
Lasso di tempo: Mean gait speed will be assessed at baseline and after each randomized eTNS condition during walking tasks, using the IDEEA inertial sensor-based gait analysis system.

This is a within-subject study. Instrumented gait parameters and clinical rating scales will be assessed at baseline, followed by eTNS stimulation in randomized order under the 120-Hz, 40-Hz, and sham conditions. After each eTNS condition, instrumented gait parameters will be collected during walking tasks. Clinical rating scales will be additionally assessed after the final stimulation condition.

Mean gait speed will be directly obtained from the IDEEA system, which uses inertial sensors to quantitatively monitor gait during walking tasks in patients with PD.
Mean gait speed will be assessed at baseline and after each randomized eTNS condition during walking tasks, using the IDEEA inertial sensor-based gait analysis system.
Mean Stride Length (m)
Lasso di tempo: Mean stride length will be assessed at baseline and after each randomized eTNS condition during walking tasks, using the IDEEA inertial sensor-based gait analysis system.
This is a within-subject study. Instrumented gait parameters and clinical rating scales will be assessed at baseline, followed by eTNS stimulation in randomized order under the 120-Hz, 40-Hz, and sham conditions. After each eTNS condition, instrumented gait parameters will be collected during walking tasks. Clinical rating scales will be additionally assessed after the final stimulation condition. Mean stride length will be directly obtained from the IDEEA system, which uses inertial sensors to quantitatively monitor gait during walking tasks in patients with PD.
Mean stride length will be assessed at baseline and after each randomized eTNS condition during walking tasks, using the IDEEA inertial sensor-based gait analysis system.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
stride frequency（steps/min）
Lasso di tempo: It will be assessed at baseline and after each randomized eTNS condition during walking tasks, using the IDEEA inertial sensor-based gait analysis system.
This is a within-subject study. Instrumented gait parameters and clinical rating scales will be assessed at baseline, followed by eTNS stimulation in randomized order under the 120-Hz, 40-Hz, and sham conditions. After each eTNS condition, instrumented gait parameters will be collected during walking tasks. Clinical rating scales will be additionally assessed after the final stimulation condition.Stride frequency will be recorded as directly generated by the IDEEA system.Improvement in stride frequency after eTNS suggests potential improvement in walking rhythm and gait control in patients with PD.
It will be assessed at baseline and after each randomized eTNS condition during walking tasks, using the IDEEA inertial sensor-based gait analysis system.
Double-support phase percentage（%）
Lasso di tempo: It will be assessed at baseline and after each randomized eTNS condition during walking tasks, using the IDEEA inertial sensor-based gait analysis system.

This is a within-subject study. Instrumented gait parameters and clinical rating scales will be assessed at baseline, followed by eTNS stimulation in randomized order under the 120-Hz, 40-Hz, and sham conditions. After each eTNS condition, instrumented gait parameters will be collected during walking tasks. Clinical rating scales will be additionally assessed after the final stimulation condition.Double-support phase percentage will be calculated as: (double-support time / gait cycle time) × 100%.

A higher Double-support phase percentage value generally indicates greater reliance on double-limb support to maintain stability, suggesting more cautious gait, impaired dynamic balance, and increased fall risk. A decrease in double-support phase percentage after eTNS suggests reduced dependence on double-limb support and potential improvement in gait stability and dynamic balance in patients with PD.
It will be assessed at baseline and after each randomized eTNS condition during walking tasks, using the IDEEA inertial sensor-based gait analysis system.
gait symmetry index（%）
Lasso di tempo: It will be assessed at baseline and after each randomized eTNS condition during walking tasks, using the IDEEA inertial sensor-based gait analysis system.
This is a within-subject study. Instrumented gait parameters and clinical rating scales will be assessed at baseline, followed by eTNS stimulation in randomized order under the 120-Hz, 40-Hz, and sham conditions. After each eTNS condition, instrumented gait parameters will be collected during walking tasks. Clinical rating scales will be additionally assessed after the final stimulation condition.The symmetry index will be calculated as: |left-side gait parameter - right-side gait parameter| / [0.5 × (left-side gait parameter + right-side gait parameter)] × 100%.The symmetry index reflects the degree of difference between left- and right-side gait parameters and is used to evaluate bilateral gait symmetry. A higher value indicates greater asymmetry, whereas a lower value indicates better gait symmetry. A decrease in the symmetry index after eTNS suggests improved bilateral gait symmetry in patients with PD.
It will be assessed at baseline and after each randomized eTNS condition during walking tasks, using the IDEEA inertial sensor-based gait analysis system.

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Hoehn and Yahr Scale
Lasso di tempo: The scale will be administered twice: once at baseline before the experiment and once after completion of all eTNS stimulation conditions and walking tasks, namely at the end of the experiment.

This is a within-subject study. Instrumented gait parameters and clinical rating scales will be assessed at baseline, followed by eTNS stimulation in randomized order under the 120-Hz, 40-Hz, and sham conditions. After each eTNS condition, instrumented gait parameters will be collected during walking tasks. Clinical rating scales will be additionally assessed after the final stimulation condition.The Hoehn and Yahr scale ranges from 1 to 5 in this study. Higher stages indicate more advanced disease and greater motor disability.

It is a clinical staging system used to assess the overall severity of Parkinson's disease based on the distribution of motor symptoms, postural instability, walking ability, and functional disability. A higher stage indicates more severe disease. A decrease in Hoehn and Yahr scale after eTNS would suggest improvement in overall motor function and disease severity.
The scale will be administered twice: once at baseline before the experiment and once after completion of all eTNS stimulation conditions and walking tasks, namely at the end of the experiment.
Incidence of eTNS-Related Adverse Reactions [Safety and Tolerability]
Lasso di tempo: Throughout the experimental session, approximately 2.5-3 hours
Adverse reactions related to eTNS will be recorded throughout the experimental session, including local skin numbness, tingling, itching, redness at the electrode site, headache, dizziness, or any other discomfort reported by the participant or observed by the investigator. The number and percentage of participants experiencing eTNS-related adverse reactions will be reported.
Throughout the experimental session, approximately 2.5-3 hours
Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III
Lasso di tempo: The scale will be administered twice: once at baseline before the experiment and once after completion of all eTNS stimulation conditions and walking tasks, namely at the end of the experiment.

This is a within-subject study. Instrumented gait parameters and clinical rating scales will be assessed at baseline, followed by eTNS stimulation in randomized order under the 120-Hz, 40-Hz, and sham conditions. After each eTNS condition, instrumented gait parameters will be collected during walking tasks. Clinical rating scales will be additionally assessed after the final stimulation condition.

Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III(MDS-UPDRS III) is a clinician-rated motor examination scale used to assess the severity of motor signs in Parkinson's disease, including rigidity, bradykinesia, tremor, gait, posture, and postural stability. The score ranges from 0 to 132, with each item rated from 0 to 4. Higher scores indicate more severe motor impairment.A decrease in the MDS-UPDRS Part III score after eTNS indicates improvement in motor function.
The scale will be administered twice: once at baseline before the experiment and once after completion of all eTNS stimulation conditions and walking tasks, namely at the end of the experiment.
Tinetti Gait Assessment
Lasso di tempo: The scale will be administered twice: once at baseline before the experiment and once after completion of all eTNS stimulation conditions and walking tasks, namely at the end of the experiment.
This is a within-subject study. Instrumented gait parameters and clinical rating scales will be assessed at baseline, followed by eTNS stimulation in randomized order under the 120-Hz, 40-Hz, and sham conditions. After each eTNS condition, instrumented gait parameters will be collected during walking tasks. Clinical rating scales will be additionally assessed after the final stimulation condition.The Tinetti Gait Assessment score ranges from 0 to 12. Higher scores indicate better gait performance and stability.The Tinetti Gait Assessment evaluates gait performance during walking, including gait initiation, step length and height, step symmetry, step continuity, walking path, trunk stability, and walking stance. A lower score indicates poorer gait function and greater gait instability, whereas a higher score indicates better gait function. An increase in the Tinetti Gait Assessment score after eTNS suggests improvement in gait function in patients with PD.
The scale will be administered twice: once at baseline before the experiment and once after completion of all eTNS stimulation conditions and walking tasks, namely at the end of the experiment.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Zhengli Di

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 giugno 2026

Completamento primario (Stimato)

15 luglio 2026

Completamento dello studio (Stimato)

15 luglio 2026

Date di iscrizione allo studio

Primo inviato

8 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

14 giugno 2026

Primo Inserito (Effettivo)

18 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • LSS-K-2026-012-01

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data will not be shared because the informed consent documents and ethics approval do not specifically include permission for public or external sharing of individual-level participant data. Aggregate study results may be shared through publications or presentations.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Malattia di Parkinson (MdP)

Prove cliniche su external Trigeminal Nerve Stimulation, eTNS

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Guatemala

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi