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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05381688
Other study ID # 256285/1
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date September 9, 2021
Est. completion date July 31, 2022

Study information

Verified date May 2022
Source University of Oxford
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Research from our group has demonstrated modulation of PEFR in patients with STN and PAG stimulation. However, the effect of VIM (motor thalamus) stimulation remains to be investigated. Our group has also been involved in research that indicates that VIM stimulation may reduce perception of breathlessness. However, methodological factors limit the conclusions that can be drawn from this prior work. N-of-1 trials, organised as a randomised multiphase crossover design, are uniquely well suited for DBS research where stimulation can be switched ON and OFF, and with simple tests that can be done quickly, multiple times. PEFR and breath-holding are simple tests that we will test in this way. Other respiratory tests will be carried out along side, as optional, in a single phase design. We aim to offer this study to a continuous cohort of patients scheduled to undergo VIM (ET/DT) DBS at our institution. We will establish a pre-operative baseline of respiratory function, and then perform the n-of-1 trial post-operatively, soon after the patient returns to hospital to receive their DBS programming.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date July 31, 2022
Est. primary completion date July 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Scheduled for VIM DBS - Diagnosis of ET or DT Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
VIM DBS
Stereotactic deep brain stimulation of ventral intermediate nucleus of thalamus

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Oxford

Outcome

Type Measure Description Time frame Safety issue
Primary Breath-hold (urge to breath) Time from start of breath-hold to urge to breathe 3 months post-operative, ON and OFF: randomised, cross over, 5-phase design
Secondary Breath-hold (break point) Time from start of breath-hold to breakpoint 3 months post-operative, ON and OFF: randomised, cross over, 5-phase design
Secondary Peak Expiratory Flow Rate Maximum PEFR of three trials 3 months post-operative, ON and OFF: randomised, cross over, 5-phase design
Secondary Dyspnoea-12 Questionnaire Difference in D12 score Baseline and 3 months post-operative
Secondary Oscillometry Difference in airway resistance Baseline and 3 months post-operative ON and OFF
Secondary Maximum inspiratory pressure Best MIP of three trials Baseline and 3 months post-operative ON and OFF
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