VIM DBS Respiratory Modulation: N-of-1 Trial

Brief Title

VIM DBS Respiratory Modulation: N-of-1 Trial

Official Title

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

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.

Study Type

Observational

Primary Outcome

Breath-hold (urge to breath)

Secondary Outcome

 Breath-hold (break point)

Condition

Essential Tremor

Intervention

VIM DBS

Study Arms / Comparison Groups

 ET VIM DBS patients

Description:  Essential tremor patients scheduled for VIM DBS

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

Start Date

September 9, 2021

Completion Date

July 31, 2022

Primary Completion Date

July 31, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Scheduled for VIM DBS

          -  Diagnosis of ET or DT

        Exclusion Criteria:

          -  None

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Alex L Green, FRCS, ,

Administrative Informations

NCT ID

NCT05381688

Organization ID

256285/1

Responsible Party

Sponsor

Study Sponsor

University of Oxford

Study Sponsor

Alex L Green, FRCS, Principal Investigator, University of Oxford

Verification Date

May 2022