Breathlessness patterns in adults with cancer, COPD, or heart failure using brain fMRI and immersive virtual reality

Breathlessness Patterns in Patients With Cancer, COPD and Heart Failure: an fMRI Feasibility Study

This project will try to use brain fMRI combined with immersive virtual reality to identify patterns of persistent breathlessness in adults with COPD, heart failure, or cancer and in healthy volunteers.

Quick facts

• Study type: Observational
• Enrollment: 16 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Geneva (Academic / other)
• Locations: 1 site (Geneva, Canton of Geneva)
• Trial ID: NCT07319039 on ClinicalTrials.gov

What this trial studies

Researchers will use cerebral functional MRI together with immersive virtual reality stimuli to record brain activity associated with persistent dyspnea in patients and in healthy control volunteers. The observational feasibility protocol enrolls adults followed at the Geneva University Hospitals outpatient palliative clinic who meet disease-specific breathlessness criteria and healthy volunteers without cardiorespiratory or oncologic disease. During imaging sessions standardized symptom ratings and IVR triggers will be applied to explore central nervous system signaling and potential disease-specific breathlessness patterns. The primary goal is to determine whether distinct, reproducible brain activity patterns can be detected across disease groups to inform future targeted therapies.

Who should consider this trial

Good fit: Adults (≥18) followed by the Geneva University Hospitals outpatient palliative clinic with persistent breathlessness (>3 weeks), NRS breathlessness >2 and <8, and a diagnosis of NYHA III-IV heart failure, COPD with mMRC grade 3–4, or cancer with pulmonary involvement are the intended participants.

Not a fit: Patients with recent hospitalization for acute cardiac, respiratory, or neurological failure, those with contraindications to fMRI, or those whose breathlessness is outside the study's NRS range (≤2 or ≥8) are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this could help match breathlessness treatments to disease-specific brain patterns and reduce one-size-fits-all prescribing such as routine opioid use.

How similar studies have performed: Previous fMRI work has mainly studied healthy volunteers or acute breathlessness and immersive VR has been used to reduce MRI anxiety, but applying fMRI plus IVR to chronic breathlessness across cancer, COPD, and heart failure is largely novel and untested.

Eligibility criteria

Inclusion Criteria

* Age ≥ 18 years and
* Followed by the outpatient palliative care clinic of the Geneva University Hospitals, Switzerland (HUG) and
* Breathlessness at rest \> 2 and \< 8 on the NRS (numeric rating scale 0 to 10) and
* Persistent breathlessness (persistent dyspnea for \> 3 weeks despite adequate and maximal medication according to the pathology) and
* In a stable clinical condition, i.e., without an episode of acute cardiac, respiratory, and/or neurological failure leading to hospitalization in the previous 4 weeks and
* Diagnosis of either HF stage NYHA III-IV, or COPD with dyspnea on the modified MRC scale grade 3-4, or oncological disease with primary or secondary pulmonary involvement

Inclusion Criteria for Healthy Volunteers (Control Group)

* Age ≥ 18 years and
* No respiratory symptoms: dyspnea, cough, wheezing and
* No known pulmonary, cardiac, or oncological disease and
* Smoking status \< 10 pack-years and
* No contraindication to fMRI (Appendix 3) and
* Ability to lie flat (supine position) and
* No diagnosed psychiatric illness (severe depression, severe anxiety, psychosis, other) or antipsychotic treatment deemed a contraindication for fMRI based on physician judgement and
* No neurological disorders according to neurological assessment, including diagnosed dementia (frontotemporal dementia, Alzheimer's disease, etc.), brain pathology (tumor, stroke, Parkinson's disease, etc.), or epilepsy and
* No claustrophobia, acrophobia, photophobia, severe hearing loss, and/or severe visual deficit and
* No contraindication to IVR (migraines, photosensitive epilepsy, vertigo)

Exclusion Criteria

* Breathlessness at rest ≥ 8 on the NRS (numeric rating scale 0 to 10)
* Contraindication to fMRI
* Inability to lie flat (supine position)
* Diagnosed psychiatric illness (severe depression, severe anxiety, psychosis, other) or antipsychotic treatment deemed a contraindication for fMRI based on physician judgement
* Neurological disorders according to neurological assessment, including diagnosed dementia (frontotemporal dementia, Alzheimer's disease, etc.), brain pathology (tumor, stroke, Parkinson's disease, etc.), or epilepsy
* Presence of claustrophobia, acrophobia, photophobia, severe hearing loss, and/or severe visual deficit
* Contraindication to IVR (migraines, photosensitive epilepsy, vertigo)

Where this trial is running

Geneva, Canton of Geneva

• Geneva University Hospitals — Geneva, Canton of Geneva, Switzerland (Recruiting)

Study contacts

• Principal investigator: Lisa Hentsch, Dr med — University Hospital, Geneva
• Study coordinator: Lisa Hentsch, Dr med

Conditions Chronic Obstructive Pulmonary Disease; Heart Failure; Cancer; Volunteers; Persistent dyspnea; Breathlessness; Palliative Medicine; Cerebral fMRI