Parkinson DiseaseNCT04058457
DBS and Respiration
An observational study of Parkinson Disease, run by University of Oxford at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- DBS
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2021to 21 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: STN (Parkinson's disease) GPi (movement disorder, control) VIM (movement disorder, control)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU
Alex Green, FRCS, 01865234762, alex.green@nds.ox.ac.uk
About this study
Official title: Deep Brain Stimulation in Parkinson's Disease: Respiratory Testing
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- DBS
- Keywords
- Parkinson disease, movement disorder, dyspnoea, dyspnea, breathlessness, respiratory
- Medical subject headings
- Parkinson Disease, Movement Disorders, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| STN DBS | Patients planned to undergo deep brain stimulation of the subthalamic nucleus Receives: Device: DBS | |
| GPi DBS | Patients planned to undergo deep brain stimulation of the globus pallidus interna Receives: Device: DBS | |
| VIM DBS | Patients planned to undergo deep brain stimulation of the ventral intermediate nucleus of thalamus. Receives: Device: DBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in breathlessness
Dyspnoea questionnaire (D12, MRC)
Measured: Pre-operatively and post-operatively (6-months)
Change in breathlessness
Breathlessness ratings (modified-Borg Scale) from experimentally induced breathlessness. 0 = none, 10 maximum. Reported every 15 seconds.
Measured: ON and OFF stimulation between 1 and 6 months after surgery
Secondary outcomes (9)
Change in pulmonary function
Spirometry
Measured: ON and OFF stimulation between 1 and 6 months after surgery
Change in airways resistance
Oscillometry
Measured: ON and OFF stimulation between 1 and 6 months after surgery
Change in respiratory muscle strength
Maximum inspiratory/expiratory pressures
Measured: ON and OFF stimulation between 1 and 6 months after surgery
Change in surface electromyography of respiratory muscles
Signal analysis for evidence of tremor
Measured: ON and OFF stimulation between 1 and 6 months after surgery
Change in hypercapnic ventilatory response
Changes in ventilation from incrementally increased inhaled CO2
Measured: ON and OFF stimulation between 1 and 6 months after surgery
Change in breath-hold
Dyspnoea threshold and breakpoint
Measured: ON and OFF stimulation between 1 and 6 months after surgery
Change in daily activity
Pedometry
Measured: Pre-operatively (10 days) and post-operatively (10 days, within 6 months of surgery once recovered from surgery and programmed)
Change in daily activity
Heart rate
Measured: Pre-operatively (10 days) and post-operatively (10 days within 6 months of surgery once recovered from surgery and programmed)
MRI structural connectivity
DTI correlation with respiratory outcomes
Measured: Pre-operative scan with post-operative analysis through study completion at an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start1 Apr 2021
- Primary completion21 Jul 2026 (estimated)
- Study completion21 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford Brookes University
- Responsible party
- Sponsor
- Investigators
- Alex Green, FRCS, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058457
- Sponsor's protocol ID
- 256825
- Status last verified
- Mar 2024
- First submitted
- 18 Jul 2019
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation in Parkinson's Disease: Respiratory Testing
- ClinicalTrials.gov ID
- NCT04058457
- Acronym / sponsor ID
- 256825
- Conditions
- Parkinson Disease
- Keywords
- Parkinson disease, movement disorder, dyspnoea, dyspnea, breathlessness, respiratory
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Oxford Brookes University
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 21 Jul 2026 (estimated)
- Study completion
- 21 Sep 2026 (estimated)
- First posted
- 15 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| STN DBS | – | Device: DBSPatients planned to undergo deep brain stimulation of the subthalamic nucleus |
| GPi DBS | – | Device: DBSPatients planned to undergo deep brain stimulation of the globus pallidus interna |
| VIM DBS | – | Device: DBSPatients planned to undergo deep brain stimulation of the ventral intermediate nucleus of thalamus. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- STN (Parkinson's disease) GPi (movement disorder, control) VIM (movement disorder, control)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBSPatients 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. | Device | GPi DBS, STN DBS, VIM DBS |
Primary outcome
Change in breathlessness
Time frame: Pre-operatively and post-operatively (6-months)
Dyspnoea questionnaire (D12, MRC)
Change in breathlessness
Time frame: ON and OFF stimulation between 1 and 6 months after surgery
Breathlessness ratings (modified-Borg Scale) from experimentally induced breathlessness. 0 = none, 10 maximum. Reported every 15 seconds.
9 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex Green, FRCS principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alex Green, FRCS (01865227645 ext. +44, alex.green@nds.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in breathlessness (time frame: Pre-operatively and post-operatively (6-months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.