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VIM DBS Respiratory Modulation: N-of-1 Trial

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University of Oxford

Status

Withdrawn

Conditions

Dystonic Tremor
Essential Tremor

Treatments

Procedure: VIM DBS

Study type

Observational

Funder types

Other

Identifiers

NCT05381688
256285/1

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Scheduled for VIM DBS
  • Diagnosis of ET or DT

Exclusion criteria

  • None

Trial design

0 participants in 2 patient groups

ET VIM DBS patients
Description:
Essential tremor patients scheduled for VIM DBS
Treatment:
Procedure: VIM DBS
DT VIM DBS patients
Description:
Dystonic tremor patients scheduled for VIM DBS
Treatment:
Procedure: VIM DBS

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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