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Immediate Effects of External Trigeminal Nerve Stimulation on Motor Dysfunction in Parkinson's Disease
Sponsor: Zhengli Di
Summary
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.
Key Details
Gender
All
Age Range
40 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-06-15
Completion Date
2026-07-15
Last Updated
2026-06-18
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Xi'an Central Hospital, Department of Neurology
Xi'an, Shaanxi, China