Dystonic Tremor, Essential Tremor
Conditions
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.
Interventions
PROCEDUREVIM DBS
Stereotactic deep brain stimulation of ventral intermediate nucleus of thalamus
Sponsors
University of Oxford
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Scheduled for VIM DBS * Diagnosis of ET or DT
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breath-hold (urge to breath) | 3 months post-operative, ON and OFF: randomised, cross over, 5-phase design | Time from start of breath-hold to urge to breathe |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Breath-hold (break point) | 3 months post-operative, ON and OFF: randomised, cross over, 5-phase design | Time from start of breath-hold to breakpoint |
| Peak Expiratory Flow Rate | 3 months post-operative, ON and OFF: randomised, cross over, 5-phase design | Maximum PEFR of three trials |
| Dyspnoea-12 Questionnaire | Baseline and 3 months post-operative | Difference in D12 score |
| Oscillometry | Baseline and 3 months post-operative ON and OFF | Difference in airway resistance |
| Maximum inspiratory pressure | Baseline and 3 months post-operative ON and OFF | Best MIP of three trials |
Outcome results
None listed