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

ConditionsChronic Obstructive Pulmonary Disease (COPD)Heart Failure Cancer Volunteers

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorUniversity Hospital, Geneva

About this trial

Dyspnea that persists despite optimal pathophysiological treatment is defined as persistent dyspnea.

Currently all brain functional magnetic resonance imaging (fMRI) studies conducted to evaluate breathlessness have done so using healthy volunteers or have concentrated on acute breathlessness. Little is known about chronic breathlessness patterns and their modulation by different triggers. Furthermore, it is currently assumed in the palliative care literature that patients suffering from different advanced and progressive diseases such as cancer, heart failure (HF) or chronic obstructive pulmonary disease (COPD) have the same triggers, perceptions and neurological pathways and thus require the same treatments/interventions (i.e. opioids as first line symptomatic pharmacologic treatment). However, it is now known that patients belonging to different disease groups do not necessarily benefit from opioids.

Aim of the study To assess the feasibility of identifying dyspnea patterns in different life-limiting conditions and to evaluate the effect of immersive virtual reality (IVR) on dyspnea using patient-reported-outcomes (PROMs).

Study procedure:

Patients with advanced chronic diseases such as cancer, COPD or HF suffering from dyspnea will undergo a brain fMRI in combination with an IVR intervention. The fMRI data will be reviewed to identify different patterns of dyspnea and the effect of IVR on dyspnea will be assessed through PROMs. Patients will be asked about the perceived burden of the study.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Followed by the outpatient palliative care clinic of the Geneva University Hospitals, Switzerland (HUG) Patient with a diagnosis of either HF stage NYHA III-IV or COPD with dyspnea on modified MRC scale grade 3-4 or oncological disease with either primary or secondary pulmonary location

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Cerebral fMRI
Other intervention
Neuroimaging data will be collected using a 3T Siemens Prisma MRI scanner (Prisma; Siemens, Erlangen, Germany) equipped with a 64-channel head coil. Functional T2\*-weighted images will be acquired during the resting-state protocol. The sequences used will be gradient-echo planar imaging. Additionally, a single-band reference volume will be obtained prior to the functional acquisition, using the same parameters but without multiband (MB) acceleration, to assist in functional realignment and masking. A whole-brain T1-weighted multi-echo MPRAGE scan will also be performed with 1 mm isotropic resolution. three echo images were combined using the root-mean-square method.
Immersive virtual reality
Other intervention
In collaboration with HypnoVR (HypnoVR, Strasbourg, France), patients will subsequently be provided with a visual immersion in a virtual world along with a scripted hypnotic voice track. HypnoVR's solution is certified as a medical device and has been studied in various medical contexts. The program will be adapted to run on its own dedicated PC instead of a (non-MRI compatible) HMD. As described in this protocol, the PL and the patients can select from a predefined set of virtual environments and choose the preferred voice-over script.

Treatment groups

16 Participants

are divided into 1 treatment group

Group A: Participants2 interventions

Trial outcomes

Primary outcomes

Feasibility of the study

Composite outcomes: 1. Recruitment rate: proportion of eligible patients who consent to participate, calculated as the number of participants enrolled divided by the total number of eligible patients approached during the recruitment period. A recruitment rate ≥ 50% will be considered feasible. 2. Retention rate: proportion of enrolled participants who complete the planned intervention (fMRI, vital signs, and study-associated questionnaires). A retention rate ≥ 70% will be considered acceptable. If both thresholds are met (recruitment rate and retention rate), progression to a larger observational study will be considered.

Time frame

18 months after the beginning of the study

Secondary outcomes

Acceptability

The acceptability for the patients is based on the intervention's perceived burden, evaluated on a 5-point Likert scale (1 meaning no burden, 5 the maximum possible burden), recorded within 15 minutes after the intervention, with a cutoff ≤ 3, indicating that the study was moderately burdensome.

Time frame

15 minutes after the procedure

Evolution of vital parameters

Saturation in oxygen (SpO2) (%) (minimum and maximum values)

Time frame

Before, during and 15 minutes after the fMRI

Evolution of vital parameters

Transcutaneous CO2 (ptCO2) (kPa) (minimum and maximum values)

Time frame

Pre and 15 minutes after the fMRI

Evolution of vital parameters

Respiratory rate over 1 minute (RR) (number/minute) (minimum and maximum values)

Time frame

Pre and 15 minutes after the fMRI

Other outcomes

fMRI parameters

Percent signal change and latency of response in BOLD (blood-oxygen-level-dependent) signal change will be assessed in relevant brain regions, including the left precentral gyrus, left middle frontal gyrus, left insula, left amygdala, left hippocampus, medial orbitofrontal cortex, and brainstem regions.

Time frame

During the procedure

fMRI parameters

Functional connectivity of the left and right anterior insula with multiple regions (anterior cingulate cortex)

Time frame

During procedure

fMRI parameters

Activation map of the brain areas with significant activity as derived from the BOLD signal

Time frame

During procedure

fMRI parameters

Peak amplitude (maximum change in BOLD signal during the trigger) will be assessed in relevant brain regions, including the left precentral gyrus, left middle frontal gyrus, left insula, left amygdala, left hippocampus, medial orbitofrontal cortex, and brainstem regions.

Time frame

during procedure

Sponsors and contacts

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University Hospital, Geneva

Lead sponsor

Source ClinicalTrials.gov

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