Clinical trial NCT04058457: DBS and Respiration
Official title: Deep Brain Stimulation in Parkinson's Disease: Respiratory Testing
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Keywords: Parkinson disease
movement disorder
dyspnoea
dyspnea
breathlessness
respiratory
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Oxford Brookes University
First posted: 2019-08-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: STN (Parkinson's disease) GPi (movement disorder, control) VIM (movement disorder, control)

Brief summary: Patients referred to neurosurgery routinely and safely undergo deep brain stimulation (DBS) for treatment of neurological conditions, most commonly Parkinson's disease.

The investigators have observed that respiratory problems (breathlessness) sometimes occur subsequent to DBS of the subthalamic nucleus (STN). This study aims to determine whether this is indeed a consequence of STN stimulation. Secondary objectives include identification of the respiratory physiological mediators of any interoceptive neuromodulation observed, changes in daily physical activity and MRI structural connectivity analysis.

Detailed description: A continuous cohort of Parkinson disease patients planned to undergo STN-DBS will be approached to participate in this study (i.e. every patient will be offered participation in the study). Over the same time period other DBS patients (GPi and VIM) will be approached before their implantation procedure to participate as controls/comparators. Participants will all be offered the full study, but will also be free to participate in a smaller number of activities if so chosen.

Patients will be assessed both pre-operatively and post-operatively where they will complete a compound respiratory questionnaire and tests of respiratory interoception and function. Post-operatively, these tests will be carried out with stimulation ON and OFF, the order of which will be randomised between patients.

Data on daily activity will be collected during pre- and post-operative windows, using a wearable pedometer/heart-rate monitor.

Positive findings of respiratory neuromodulation will be correlated between patients with structural connectivity (e.g. STN-insula.) from pre-operative MRI scans.

Eligibility criteria: Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or female, aged 18 years or above.
* Planned for required DBS surgery
* Fluent in the English language
* For experimental group: diagnosed with Parkinson's disease

Exclusion Criteria:

* Female who is pregnant
* Subject is currently participating in a clinical investigation that includes an active treatment arm which may affect the respiratory system.
* Acute respiratory problem at time of experimental session: e.g. rhinosinusitis, pharyngitis, asthma exacerbation

Primary outcomes:
measure: Change in breathlessness
timeFrame: Pre-operatively and post-operatively (6-months)
measure: Change in breathlessness
timeFrame: ON and OFF stimulation between 1 and 6 months after surgery
Secondary outcomes:
measure: Change in pulmonary function
timeFrame: ON and OFF stimulation between 1 and 6 months after surgery
measure: Change in airways resistance
timeFrame: ON and OFF stimulation between 1 and 6 months after surgery
measure: Change in respiratory muscle strength
timeFrame: ON and OFF stimulation between 1 and 6 months after surgery
measure: Change in surface electromyography of respiratory muscles
timeFrame: ON and OFF stimulation between 1 and 6 months after surgery
measure: Change in hypercapnic ventilatory response
timeFrame: ON and OFF stimulation between 1 and 6 months after surgery
measure: Change in breath-hold
timeFrame: ON and OFF stimulation between 1 and 6 months after surgery
measure: Change in daily activity
timeFrame: Pre-operatively (10 days) and post-operatively (10 days, within 6 months of surgery once recovered from surgery and programmed)
measure: Change in daily activity
timeFrame: Pre-operatively (10 days) and post-operatively (10 days within 6 months of surgery once recovered from surgery and programmed)
measure: MRI structural connectivity
timeFrame: Pre-operative scan with post-operative analysis through study completion at an average of 1 year
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
state: Oxfordshire
Study officials:
affiliation: University of Oxford
name: Alex Green, FRCS
role: PRINCIPAL_INVESTIGATOR
References: