Parkinson's Disease (PD)NCT07656129
Immediate Effects of External Trigeminal Nerve Stimulation on Motor Dysfunction in Parkinson's Disease
A study testing external Trigeminal Nerve Stimulation, eTNS in people with Parkinson's Disease (PD), run by Zhengli Di at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson's Disease (PD)
- What is being tested?
- external Trigeminal Nerve Stimulation, eTNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2026to 15 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Hoehn and Yahr stage 1-5 in the medication ON state.
- Mini-Mental State Examination (MMSE) score >24.
- Stable antiparkinsonian medication for at least 1 month before the trial.
- No history of orthopedic or musculoskeletal disorders, and no other conditions that may affect balance or gait, such as ophthalmologic disorders.
- 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.
- Age between 40 and 80 years.
- Ability to cooperate with all assessments and eTNS treatment, and provision of written informed consent.
Who cannot join
- Secondary parkinsonism or atypical parkinsonian syndromes.
- Current use of anticholinergic medications.
- Contraindications to non-invasive electrical neuromodulation.
- Previous eTNS treatment within the past 6 months.
- Severe neurological, renal, cardiovascular, hepatic, or other major systemic diseases.
- Inability to complete clinical assessments or refusal to provide written informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xi'an Central Hospital, Department of Neurology
Xi'an, Shaanxi, 710000
Rong Li, PhD candidate, +86 15529957876, 15529957876@163.com
About this study
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.
Read more
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.
- Conditions
- Parkinson's Disease (PD)
- Being tested
- external Trigeminal Nerve Stimulation, eTNS
- Keywords
- external Trigeminal Nerve Stimulation, Parkinson's Disease, Motor dysfunction
- Medical subject headings
- Parkinson Disease, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
external Trigeminal Nerve Stimulation, eTNSDevice
Also called Anti-parkinson's disease drugs
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.
| Study group | Role | What they receive |
|---|---|---|
| 40Hz-eTNS | Active comparator | 40-Hz eTNS: frequency,40Hz; pulse width, 250 μs; duty cycle, 30 s on/30 s off; total stimulation duration, 20 min. Receives: Device: external Trigeminal Nerve Stimulation, eTNS |
| 120Hz-eTNS | Active comparator | 120-Hz eTNS: frequency,120Hz; pulse width, 250 μs; duty cycle, 30 s on/30 s off; total stimulation duration, 20 min. Receives: Device: external Trigeminal Nerve Stimulation, eTNS |
| sham-eTNS | Sham comparator | 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). Receives: Device: external Trigeminal Nerve Stimulation, eTNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dual-Task Cost (DTC)
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.
Measured: 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）
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.
Measured: 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)
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.
Measured: 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.
Secondary outcomes (3)
stride frequency（steps/min）
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.
Measured: 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（%）
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.
Measured: 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（%）
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.
Measured: It will be assessed at baseline and after each randomized eTNS condition during walking tasks, using the IDEEA inertial sensor-based gait analysis system.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start15 Jun 2026 (estimated)
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each patient will complete three conditions in a single session in randomized order
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhengli Di
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhengli Di, Xi'an Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07656129
- Sponsor's protocol ID
- LSS-K-2026-012-01
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of External Trigeminal Nerve Stimulation on Motor Dysfunction in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07656129
- Acronym / sponsor ID
- LSS-K-2026-012-01
- Conditions
- Parkinson's Disease (PD)
- Keywords
- external Trigeminal Nerve Stimulation, Parkinson's Disease, Motor dysfunction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zhengli DiUniversity, hospital or other
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Each patient will complete three conditions in a single session in randomized order
| Arm | Type | Receives |
|---|---|---|
| 40Hz-eTNS | Active comparator | Device: external Trigeminal Nerve Stimulation, eTNS40-Hz eTNS: frequency,40Hz; pulse width, 250 μs; duty cycle, 30 s on/30 s off; total stimulation duration, 20 min. |
| 120Hz-eTNS | Active comparator | Device: external Trigeminal Nerve Stimulation, eTNS120-Hz eTNS: frequency,120Hz; pulse width, 250 μs; duty cycle, 30 s on/30 s off; total stimulation duration, 20 min. |
| sham-eTNS | Sham comparator | Device: external Trigeminal Nerve Stimulation, eTNSSham 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). |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- Hoehn and Yahr stage 1-5 in the medication ON state.
- Mini-Mental State Examination (MMSE) score >24.
- Stable antiparkinsonian medication for at least 1 month before the trial.
- No history of orthopedic or musculoskeletal disorders, and no other conditions that may affect balance or gait, such as ophthalmologic disorders.
Key exclusion criteria (6 listed)
- Secondary parkinsonism or atypical parkinsonian syndromes.
- Current use of anticholinergic medications.
- Contraindications to non-invasive electrical neuromodulation.
- Previous eTNS treatment within the past 6 months.
- Severe neurological, renal, cardiovascular, hepatic, or other major systemic diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| external Trigeminal Nerve Stimulation, eTNSAlso: Anti-parkinson's disease drugsThe 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. | Device | 120Hz-eTNS, 40Hz-eTNS, sham-eTNS |
Primary outcome
Dual-Task Cost (DTC)
Time frame: 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.
Mean Gait Speed（m/s）
Time frame: 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 Stride Length (m)
Time frame: 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.
3 secondary outcomes
stride frequency（steps/min）
Time frame: 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（%）
Time frame: 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（%）
Time frame: It will be assessed at baseline and after each randomized eTNS condition during walking tasks, using the IDEEA inertial sensor-based gait analysis system.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing external Trigeminal Nerve Stimulation, eTNS in people with Parkinson's Disease (PD), run by Zhengli Di at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rong Li, PhD candidate (+86 15529957876, 15529957876@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dual-Task Cost (DTC) (time frame: DTC will be assessed at baseline and after each randomized eTNS condition during walking tasks, using the IDEEA inertial sensor based gait analysis system.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.