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DBS and Respiration

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University of Oxford

Status

Enrolling

Conditions

Parkinson Disease

Treatments

Device: DBS

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

60 participants in 3 patient groups

STN DBS
Description:
Patients planned to undergo deep brain stimulation of the subthalamic nucleus
Treatment:
Device: DBS
GPi DBS
Description:
Patients planned to undergo deep brain stimulation of the globus pallidus interna
Treatment:
Device: DBS
VIM DBS
Description:
Patients planned to undergo deep brain stimulation of the ventral intermediate nucleus of thalamus.
Treatment:
Device: DBS

Trial contacts and locations

1

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Central trial contact

Alex Green, FRCS

Data sourced from clinicaltrials.gov

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