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NCT Number: NCT04058457

DBS and Respiration

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

John Radcliffe Hospital

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location status: Recruiting

Location contact

Alex Green, FRCS

CONTACT

[email protected]

01865234762

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DBS

Device

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 outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Alex Green, FRCS

CONTACT

[email protected]

01865227645 ext. +44

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • Oxford Brookes University

Registry information

Official study title

Deep Brain Stimulation in Parkinson's Disease: Respiratory Testing

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Aug 15, 2019
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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