VIM DBS Respiratory Modulation: N-of-1 Trial

NCT05381688 | Withdrawn DMC

• 1 other identifier: 256285/1
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Essential Tremor; Dystonic Tremor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Breath-hold (break point)

  3 months post-operative, ON and OFF: randomised, cross over, 5-phase design

• Peak Expiratory Flow Rate

  3 months post-operative, ON and OFF: randomised, cross over, 5-phase design

• Dyspnoea-12 Questionnaire

  Baseline and 3 months post-operative

• Oscillometry

  Baseline and 3 months post-operative ON and OFF

• Maximum inspiratory pressure

  Baseline and 3 months post-operative ON and OFF

Study Arms (2)

ET VIM DBS patients

Essential tremor patients scheduled for VIM DBS

Procedure: VIM DBS

DT VIM DBS patients

Dystonic tremor patients scheduled for VIM DBS

Procedure: VIM DBS

Interventions

VIM DBS PROCEDURE

Stereotactic deep brain stimulation of ventral intermediate nucleus of thalamus

DT VIM DBS patients; ET VIM DBS patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Scheduled for VIM DBS
• Diagnosis of ET or DT

You may not qualify if:

• None

Sponsors & Collaborators

• University of Oxford: lead

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Alex L Green, FRCS

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 19, 2022
• Study Start: September 9, 2021
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: November 17, 2025

Record last verified: 2022-05