VIM DBS Respiratory Modulation: N-of-1 Trial

Withdrawn

• Conditions: Essential Tremor; Dystonic Tremor
• Interventions: Procedure: VIM DBS

• Registration Number: NCT05381688
• Lead Sponsor: University of Oxford

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-27
• Study Start: 2021-09-09
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-18
• Last Update Submitted: 2022-05-18
• Study First Posted: 2022-05-19
• Last Update Posted: 2022-05-19
• Primary Completion: 2022-07-31
• Study Completion: 2022-07-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Scheduled for VIM DBS
• Diagnosis of ET or DT

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DT VIM DBS patients	VIM DBS	Dystonic tremor patients scheduled for VIM DBS
ET VIM DBS patients	VIM DBS	Essential tremor patients scheduled for VIM DBS

Primary Outcome Measures

Name	Time	Method
Breath-hold (urge to breath)	3 months post-operative, ON and OFF: randomised, cross over, 5-phase design	Time from start of breath-hold to urge to breathe

Secondary Outcome Measures

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