Recruiting

eTNSFeasibility of Noninvasive Trigeminal Nerve Stimulation During Exercise

Sponsor:

Johns Hopkins University

Code:

NCT07686302

Conditions

COPD

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Active Stimulation

Sham Stimulation

Fan therapy

Study Details

Brief summary:

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).

Conditions

COPD

Study ID

NCT07686302

Start date

Oct 28, 2026

Status verified date

Nov, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Healthy Volunteers

experimental: Participants With COPD

Interventions

Active Stimulation

Active Non-Invasive Trigeminal Nerve Stimulation

Sham Stimulation

Fan therapy

Handheld fan

Primary outcome measure

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 ]

Central Contacts and Locations

Central contacts

Luu Pham, MD

410-550-2118 luu.pham@jhmi.edu

Locations

Johns Hopkins Bayview Medical Center

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Luu Pham, MD

410-550-2118 lpham1@jhmi.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Nov 12, 2026

Last verified

Nov, 2026

Keywords

dyspnea
Control of breathing
neural stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-13. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-11-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.