Essential TremorNCT05381688
VIM DBS Respiratory Modulation: N-of-1 Trial
An observational study of Essential Tremor and Dystonic Tremor, run by University of Oxford.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Tremor, Dystonic Tremor
- What is being tested?
- VIM DBS
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 9 Sep 2021to 31 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Scheduled for VIM DBS
- Diagnosis of ET or DT
Who cannot join
- None
About this study
Official title: Respiratory Modulation by VIM Deep Brain Stimulation: N-of-1 Trial of Breath-holding and Peak Expiratory Flow
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
- Being tested
- VIM DBS
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIM DBSProcedure or surgery
Stereotactic deep brain stimulation of ventral intermediate nucleus of thalamus
| Study group | Role | What they receive |
|---|---|---|
| ET VIM DBS patients | Essential tremor patients scheduled for VIM DBS Receives: Procedure: VIM DBS | |
| DT VIM DBS patients | Dystonic tremor patients scheduled for VIM DBS Receives: Procedure: VIM DBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breath-hold (urge to breath)
Time from start of breath-hold to urge to breathe
Measured: 3 months post-operative, ON and OFF: randomised, cross over, 5-phase design
Secondary outcomes (5)
Breath-hold (break point)
Time from start of breath-hold to breakpoint
Measured: 3 months post-operative, ON and OFF: randomised, cross over, 5-phase design
Peak Expiratory Flow Rate
Maximum PEFR of three trials
Measured: 3 months post-operative, ON and OFF: randomised, cross over, 5-phase design
Dyspnoea-12 Questionnaire
Difference in D12 score
Measured: Baseline and 3 months post-operative
Oscillometry
Difference in airway resistance
Measured: Baseline and 3 months post-operative ON and OFF
Maximum inspiratory pressure
Best MIP of three trials
Measured: Baseline and 3 months post-operative ON and OFF
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start9 Sep 2021
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Why it stopped: Covid prevented us from performing the study and the funding ran out
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alex L Green, FRCS, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05381688
- Sponsor's protocol ID
- 256285/1
- Status last verified
- May 2022
- First submitted
- 27 Apr 2021
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Modulation by VIM Deep Brain Stimulation: N-of-1 Trial of Breath-holding and Peak Expiratory Flow
- ClinicalTrials.gov ID
- NCT05381688
- Acronym / sponsor ID
- 256285/1
- Conditions
- Essential Tremor, Dystonic Tremor
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Covid prevented us from performing the study and the funding ran out
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ET VIM DBS patients | – | Procedure: VIM DBSEssential tremor patients scheduled for VIM DBS |
| DT VIM DBS patients | – | Procedure: VIM DBSDystonic tremor patients scheduled for VIM DBS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- Scheduled for VIM DBS
- Diagnosis of ET or DT
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIM DBSStereotactic deep brain stimulation of ventral intermediate nucleus of thalamus | Procedure or surgery | DT VIM DBS patients, ET VIM DBS patients |
Primary outcome
Breath-hold (urge to breath)
Time frame: 3 months post-operative, ON and OFF: randomised, cross over, 5-phase design
Time from start of breath-hold to urge to breathe
5 secondary outcomes
Breath-hold (break point)
Time frame: 3 months post-operative, ON and OFF: randomised, cross over, 5-phase design
Peak Expiratory Flow Rate
Time frame: 3 months post-operative, ON and OFF: randomised, cross over, 5-phase design
Dyspnoea-12 Questionnaire
Time frame: Baseline and 3 months post-operative
Oscillometry
Time frame: Baseline and 3 months post-operative ON and OFF
Maximum inspiratory pressure
Time frame: Baseline and 3 months post-operative ON and OFF
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex L Green, FRCS principal investigator
University of Oxford
Questions about this trial
What is this clinical trial studying?
An observational study of Essential Tremor and Dystonic Tremor, run by University of Oxford.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breath-hold (urge to breath) (time frame: 3 months post-operative, ON and OFF: randomised, cross over, 5-phase design). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.