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Covid prevented us from performing the study and the funding ran out
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ET VIM DBS patients | Essential tremor patients scheduled for VIM DBS |
| |
| DT VIM DBS patients | Dystonic tremor patients scheduled for VIM DBS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIM DBS | Procedure | Stereotactic deep brain stimulation of ventral intermediate nucleus of thalamus |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Breath-hold (break point) | Time from start of breath-hold to breakpoint | 3 months post-operative, ON and OFF: randomised, cross over, 5-phase design |
| Peak Expiratory Flow Rate | Maximum PEFR of three trials |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Alex L Green, FRCS | University of Oxford | Principal Investigator |
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| ID | Term |
|---|---|
| D020329 | Essential Tremor |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 3 months post-operative, ON and OFF: randomised, cross over, 5-phase design |
| Dyspnoea-12 Questionnaire | Difference in D12 score | Baseline and 3 months post-operative |
| Oscillometry | Difference in airway resistance | Baseline and 3 months post-operative ON and OFF |
| Maximum inspiratory pressure | Best MIP of three trials | Baseline and 3 months post-operative ON and OFF |