DBS and Respiration

Parkinson Disease Clinical Trial

Official title:

Deep Brain Stimulation in Parkinson's Disease: Respiratory Testing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04058457
• Other study ID #: 256825
• Status: Recruiting
• Start date: April 1, 2021
• Est. completion date: September 21, 2024

Study information

• Verified date: November 2023
• Source: University of Oxford
• Contact: Alex Green, FRCS
• Phone: 01865227645
• Email: alex.green[@]nds.ox.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 21, 2024
• Est. primary completion date: July 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	John Radcliffe Hospital	Oxford	Oxfordshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	Oxford Brookes University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in breathlessness	Dyspnoea questionnaire (D12, MRC)	Pre-operatively and post-operatively (6-months)
Primary	Change in breathlessness	Breathlessness ratings (modified-Borg Scale) from experimentally induced breathlessness. 0 = none, 10 maximum. Reported every 15 seconds.	ON and OFF stimulation between 1 and 6 months after surgery
Secondary	Change in pulmonary function	Spirometry	ON and OFF stimulation between 1 and 6 months after surgery
Secondary	Change in airways resistance	Oscillometry	ON and OFF stimulation between 1 and 6 months after surgery
Secondary	Change in respiratory muscle strength	Maximum inspiratory/expiratory pressures	ON and OFF stimulation between 1 and 6 months after surgery
Secondary	Change in surface electromyography of respiratory muscles	Signal analysis for evidence of tremor	ON and OFF stimulation between 1 and 6 months after surgery
Secondary	Change in hypercapnic ventilatory response	Changes in ventilation from incrementally increased inhaled CO2	ON and OFF stimulation between 1 and 6 months after surgery
Secondary	Change in breath-hold	Dyspnoea threshold and breakpoint	ON and OFF stimulation between 1 and 6 months after surgery
Secondary	Change in daily activity	Pedometry	Pre-operatively (10 days) and post-operatively (10 days, within 6 months of surgery once recovered from surgery and programmed)
Secondary	Change in daily activity	Heart rate	Pre-operatively (10 days) and post-operatively (10 days within 6 months of surgery once recovered from surgery and programmed)
Secondary	MRI structural connectivity	DTI correlation with respiratory outcomes	Pre-operative scan with post-operative analysis through study completion at an average of 1 year