VIM DBS Respiratory Modulation: N-of-1 Trial

NCT ID: NCT05381688

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-09
• Study Completion Date: 2022-07-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ET VIM DBS patients

Essential tremor patients scheduled for VIM DBS

VIM DBS

Intervention Type: PROCEDURE

Stereotactic deep brain stimulation of ventral intermediate nucleus of thalamus

DT VIM DBS patients

Dystonic tremor patients scheduled for VIM DBS

VIM DBS

Intervention Type: PROCEDURE

Stereotactic deep brain stimulation of ventral intermediate nucleus of thalamus

Interventions

VIM DBS

Stereotactic deep brain stimulation of ventral intermediate nucleus of thalamus

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Scheduled for VIM DBS
• Diagnosis of ET or DT

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alex L Green, FRCS

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Other Identifiers

256285/1

Identifier Type: -

Identifier Source: org_study_id