Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

DBS and Respiration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04058457
Recruitment Status : Recruiting
First Posted : August 15, 2019
Last Update Posted : May 19, 2022
Sponsor:
Collaborator:
Oxford Brookes University
Information provided by (Responsible Party):
University of Oxford

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.


Condition or disease Intervention/treatment
Parkinson Disease Device: DBS

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Deep Brain Stimulation in Parkinson's Disease: Respiratory Testing
Actual Study Start Date : April 1, 2021
Estimated Primary Completion Date : July 21, 2023
Estimated Study Completion Date : September 21, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
STN DBS
Patients planned to undergo deep brain stimulation of the subthalamic nucleus
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.

GPi DBS
Patients planned to undergo deep brain stimulation of the globus pallidus interna
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.

VIM DBS
Patients planned to undergo deep brain stimulation of the ventral intermediate nucleus of thalamus.
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 :
  1. Change in breathlessness [ Time Frame: Pre-operatively and post-operatively (6-months) ]
    Dyspnoea questionnaire (D12, MRC)

  2. 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.


Secondary Outcome Measures :
  1. Change in pulmonary function [ Time Frame: ON and OFF stimulation between 1 and 6 months after surgery ]
    Spirometry

  2. Change in airways resistance [ Time Frame: ON and OFF stimulation between 1 and 6 months after surgery ]
    Oscillometry

  3. Change in respiratory muscle strength [ Time Frame: ON and OFF stimulation between 1 and 6 months after surgery ]
    Maximum inspiratory/expiratory pressures

  4. Change in surface electromyography of respiratory muscles [ Time Frame: ON and OFF stimulation between 1 and 6 months after surgery ]
    Signal analysis for evidence of tremor

  5. Change in hypercapnic ventilatory response [ Time Frame: ON and OFF stimulation between 1 and 6 months after surgery ]
    Changes in ventilation from incrementally increased inhaled CO2

  6. Change in breath-hold [ Time Frame: ON and OFF stimulation between 1 and 6 months after surgery ]
    Dyspnoea threshold and breakpoint

  7. 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) ]
    Pedometry

  8. 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) ]
    Heart rate

  9. MRI structural connectivity [ Time Frame: Pre-operative scan with post-operative analysis through study completion at an average of 1 year ]
    DTI correlation with respiratory outcomes



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
STN (Parkinson's disease) GPi (movement disorder, control) VIM (movement disorder, control)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04058457


Contacts
Layout table for location contacts
Contact: Alex Green, FRCS 01865227645 ext +44 alex.green@nds.ox.ac.uk

Locations
Layout table for location information
United Kingdom
John Radcliffe Hospital Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Contact: Alex Green, FRCS    01865234762    alex.green@nds.ox.ac.uk   
Sponsors and Collaborators
University of Oxford
Oxford Brookes University
Investigators
Layout table for investigator information
Principal Investigator: Alex Green, FRCS University of Oxford
Layout table for additonal information
Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT04058457    
Other Study ID Numbers: 256825
First Posted: August 15, 2019    Key Record Dates
Last Update Posted: May 19, 2022
Last Verified: May 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Oxford:
Parkinson disease
movement disorder
dyspnoea
dyspnea
breathlessness
respiratory
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases