DBS and Respiration
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DBS.
- Who it may be relevant to
- Registry conditions: Parkinson Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Deep Brain Stimulation in Parkinson's Disease: Respiratory Testing
Overview
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.
Interventions
- Device DBS
Patients are tested pre-operatively and the post-operatively with their implanted neurostimulators ON and OFF. DBS implantation itself is part of routine care, and not part of the study.
Primary outcome measures
- Change in breathlessness [Time frame: Pre-operatively and post-operatively (6-months)]
- Change in breathlessness [Time frame: ON and OFF stimulation between 1 and 6 months after surgery]
Secondary outcome measures (9)
- Change in pulmonary function [Time frame: ON and OFF stimulation between 1 and 6 months after surgery]
- Change in airways resistance [Time frame: ON and OFF stimulation between 1 and 6 months after surgery]
- Change in respiratory muscle strength [Time frame: ON and OFF stimulation between 1 and 6 months after surgery]
- Change in surface electromyography of respiratory muscles [Time frame: ON and OFF stimulation between 1 and 6 months after surgery]
- Change in hypercapnic ventilatory response [Time frame: ON and OFF stimulation between 1 and 6 months after surgery]
- Change in breath-hold [Time frame: ON and OFF stimulation between 1 and 6 months after surgery]
- Change in daily activity [Time frame: Pre-operatively (10 days) and post-operatively (10 days, within 6 months of surgery once recovered from surgery and programmed)]
- Change in daily activity [Time frame: Pre-operatively (10 days) and post-operatively (10 days within 6 months of surgery once recovered from surgery and programmed)]
- MRI structural connectivity [Time frame: Pre-operative scan with post-operative analysis through study completion at an average of 1 year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
United Kingdom · 1 center
- John Radcliffe Hospital — Oxford
Identifiers
NCT: NCT04058457 · 256825