VIM DBS Respiratory Modulation: N-of-1 Trial

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Essential Tremor; Dystonic Tremor
• Intervention / Treatment: Procedure: VIM DBS

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Sequential cohort of patients with movement disorders (ET and DT) who are scheduled for VIM DBS at John Radcliffe Hospital. All will be contacted by a member of clinical care team for the study to be offered.

Description

Inclusion Criteria:

• Scheduled for VIM DBS
• Diagnosis of ET or DT

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ET VIM DBS patients; Essential tremor patients scheduled for VIM DBS	Procedure: VIM DBS; Stereotactic deep brain stimulation of ventral intermediate nucleus of thalamus
DT VIM DBS patients; Dystonic tremor patients scheduled for VIM DBS	Procedure: VIM DBS; Stereotactic deep brain stimulation of ventral intermediate nucleus of thalamus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Peak Expiratory Flow Rate	Maximum PEFR of three trials	3 months post-operative, ON and OFF: randomised, cross over, 5-phase design
Dyspnoea-12 Questionnaire	Difference in D12 score	Baseline and 3 months post-operative
Oscillometry	Difference in airway resistance	Baseline and 3 months post-operative ON and OFF
Maximum inspiratory pressure	Best MIP of three trials	Baseline and 3 months post-operative ON and OFF

Collaborators and Investigators

• Sponsor: University of Oxford
• Investigators: Principal Investigator: Alex L Green, FRCS, University of Oxford

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 9, 2021
• Primary Completion (ANTICIPATED): July 31, 2022
• Study Completion (ANTICIPATED): July 31, 2022

Study Registration Dates

• First Submitted: April 27, 2021
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (ACTUAL): May 19, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Movement Disorders; Dyskinesias; Tremor; Essential Tremor
• Other Study ID Numbers: 256285/1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No