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

Status Withdrawn

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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Essential Tremor
• Tremor

• NCT number: NCT05381688
• Study type: Observational
• Source: University of Oxford
• Status: Withdrawn
• Start date: September 9, 2021
• Completion date: July 31, 2022