Feasibility of Noninvasive Trigeminal Nerve Stimulation During Exercise

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07686302

Enrollment

Registered

2026-07-07

Start date

2026-10-01

Completion date

2027-09-30

Last updated

2026-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Keywords

dyspnea, Control of breathing, neural stimulation

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).

Interventions

PROCEDUREActive Stimulation

Active Non-Invasive Trigeminal Nerve Stimulation

PROCEDURESham Stimulation

Sham Stimulation

PROCEDUREFan therapy

Handheld fan

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Proportion of participants with a >4 bpm decrease in heart rate	1 day	Trigeminal autonomic engagement. Proportion of participants with a \>4 bpm decrease in heart rate during active eTNS compared to sham stimulation.
Proportion of enrolled participants who complete all randomized stimulation conditions	1 day	Protocol completion rate measured by proportion of enrolled participants who complete all randomized stimulation conditions.

Secondary

Measure	Time frame	Description
Minute Ventilation	1 day	Minute Ventilation
Dyspnea severity as assessed by the Borg CR10 scale	1 day	Borg CR10 score before and during stimulation. Scale range 0-10 higher score worse severity

Contacts

CONTACTLuu Pham, MD

luu.pham@jhmi.edu410-550-2118

PRINCIPAL_INVESTIGATORLuu Pham, MD

Johns Hopkins University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 8, 2026