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Not yet recruiting NCT07686302

Feasibility of Noninvasive Trigeminal Nerve Stimulation During Exercise

No phase Interventional COPD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Active Stimulation, Sham Stimulation, Fan therapy.
Who it may be relevant to
Registry conditions: COPD. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Noninvasive Trigeminal Nerve Stimulation for Dyspnea: Mechanistic Characterization in Healthy Volunteers and Feasibility in COPD

Overview

The purpose of this study is to examine 1) effects of cutaneous electrical trigeminal nerve stimulation (eTNS) on respiratory control in healthy volunteers and 2) explore the potential of this approach to mitigate dyspnea in patients with chronic obstructive lung disease (COPD).

Interventions

  • Procedure Active Stimulation
    Active Non-Invasive Trigeminal Nerve Stimulation
  • Procedure Sham Stimulation
    Sham Stimulation
  • Procedure Fan therapy
    Handheld fan

Primary outcome measures

  • Proportion of participants with a >4 bpm decrease in heart rate [Time frame: 1 day]
  • Proportion of enrolled participants who complete all randomized stimulation conditions [Time frame: 1 day]
Secondary outcome measures (2)
  • Minute Ventilation [Time frame: 1 day]
  • Dyspnea severity as assessed by the Borg CR10 scale [Time frame: 1 day]

Eligibility criteria

Arm1 - Healthy Volunteers

Inclusion criteria

  • Adults aged 18-50 years
  • BMI 18-30 kg/m²
  • Ability to provide informed consent and complete study procedures in English

Exclusion criteria

  • Current daytime respiratory impairment such as uncontrolled asthma, uncontrolled COPD, pneumonia, or interstitial lung disease
  • Use of supplemental oxygen
  • Pregnancy or breastfeeding
  • Current use of acetazolamide, Sodium-glucose cotransporter-2 (SGLT2) inhibitors, or daily opioids
  • History of claustrophobia or panic disorder
  • Metallic implants in the craniofacial or cervical region that may interfere with electrode placement or electrical stimulation
  • Implanted cardiac or neuroelectric device (e.g., pacemaker, implantable cardioverter-defibrillator (ICD), deep brain stimulator, vagus nerve stimulator, implanted drug pump)
  • Open, broken, inflamed, infected, or healing skin lesions at or near facial electrode placement sites
  • Resting heart rate <60 Beats Per Minute
  • History of seizure disorder or epilepsy

Arm 2 -COPD

Inclusion criteria

  • Adults aged 40-75 years
  • Confirmed diagnosis of COPD by spirometry (post-bronchodilator Forced Expiratory Volume (FEV1) /Forced Vital Capacity (FVC) <0.70) or provider documentation in medical records
  • Modified Medical Research Council (mMRC) dyspnea grade ≥2
  • Stable COPD (no exacerbation requiring hospitalization, systemic corticosteroids, or antibiotic therapy within the preceding 6 weeks)
  • On stable COPD therapy for at least 4 weeks prior to enrollment
  • Ability to provide informed consent and complete questionnaires in English
  • Resting Peripheral Capillary Oxygen Saturation (SpO₂) ≥88% on room air or prescribed supplemental oxygen

Exclusion criteria

  • Unstable cardiovascular disease (e.g., unstable angina, decompensated heart failure, recent MI within 6 months, uncontrolled arrhythmia) or peripheral vascular disease
  • Patients with cardiovascular disease, including chest pain, heart failure, and aortic stenosis
  • Resting heart rate <60 BPM
  • Implanted cardiac or neuroelectric device (e.g., pacemaker, ICD, deep brain stimulator, vagus nerve stimulator, implanted drug pump)
  • Metallic implants in the craniofacial or cervical region that may interfere with electrode placement or stimulation
  • Open, broken, inflamed, infected, or healing skin lesions at or near facial electrode placement sites
  • Active trigeminal neuralgia or other cranial neuropathy
  • History of seizure disorder or epilepsy
  • Severe or uncontrolled psychiatric disorder (e.g., psychosis, severe untreated anxiety or panic disorder) that would impair the ability to participate
  • Pregnancy or breastfeeding
  • COPD exacerbation requiring hospitalization, systemic corticosteroids, or antibiotics within the preceding 3 months
  • Musculoskeletal pain, injury, or any other condition that precludes the use of a stationary bike for Cardiopulmonary Exercise Test (CPET)
  • Any condition that, in the opinion of the investigator, would compromise participant safety or data integrity

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Single blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07686302 · IRB00551380

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗