NCT04058457

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
5mo left

Started Apr 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress93%
Apr 2021Sep 2026

First Submitted

Initial submission to the registry

July 18, 2019

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 15, 2019

Completed
1.6 years until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2026

Last Updated

March 27, 2025

Status Verified

March 1, 2024

Enrollment Period

5.3 years

First QC Date

July 18, 2019

Last Update Submit

March 26, 2025

Conditions

Parkinson Disease

Keywords

Parkinson diseasemovement disorderdyspnoeadyspneabreathlessnessrespiratory

Outcome Measures

Primary Outcomes (2)

  • Change in breathlessness

    Dyspnoea questionnaire (D12, MRC)

    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.

    ON and OFF stimulation between 1 and 6 months after surgery

Secondary Outcomes (9)

  • Change in pulmonary function

    ON and OFF stimulation between 1 and 6 months after surgery

  • Change in airways resistance

    ON and OFF stimulation between 1 and 6 months after surgery

  • Change in respiratory muscle strength

    ON and OFF stimulation between 1 and 6 months after surgery

  • Change in surface electromyography of respiratory muscles

    ON and OFF stimulation between 1 and 6 months after surgery

  • Change in hypercapnic ventilatory response

    ON and OFF stimulation between 1 and 6 months after surgery

  • +4 more secondary outcomes

Study Arms (3)

STN DBS

Patients planned to undergo deep brain stimulation of the subthalamic nucleus

Device: DBS

GPi DBS

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

Device: DBS

VIM DBS

Patients planned to undergo deep brain stimulation of the ventral intermediate nucleus of thalamus.

Device: DBS

Interventions

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.

GPi DBSSTN DBSVIM DBS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

STN (Parkinson's disease) GPi (movement disorder, control) VIM (movement disorder, control)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

John Radcliffe Hospital

Oxford, Oxfordshire, OX3 9DU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Parkinson DiseaseMovement DisordersDyspnea

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSynucleinopathiesNeurodegenerative DiseasesRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alex Green, FRCS

    University of Oxford

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alex Green, FRCS

CONTACT

01865227645alex.green@nds.ox.ac.uk

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2019

First Posted

August 15, 2019

Study Start

April 1, 2021

Primary Completion (Estimated)

July 21, 2026

Study Completion (Estimated)

September 21, 2026

Last Updated

March 27, 2025

Record last verified: 2024-03

Locations

GB(1)