VIM DBS Respiratory Modulation: N-of-1 Trial

Essential Tremor Clinical Trial

Official title:

Respiratory Modulation by VIM Deep Brain Stimulation: N-of-1 Trial of Breath-holding and Peak Expiratory Flow

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05381688
• Other study ID #: 256285/1
• Status: Withdrawn
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Essential Tremor
• Tremor

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