Vestibular SchwannomaKINE HITNCT06660082
Early Rehabilitation Using Head Impulse Test for Acute Vestibular Deficit
A study testing Experimental treatment: Head movements in people with Vestibular Schwannoma and Unilateral Vestibular Deficit, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The vestibulo-ocular reflex (VOR) induces a compensatory movement in the eye when the head is rotated, to maintain stable vision when we move. It originates in the peripheral vestibular system, which detects head movements. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Vestibular Schwannoma, Unilateral Vestibular Deficit
- What is being tested?
- Experimental treatment: Head movements
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 13 May 2025to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with unilateral vestibular schwannoma and programmed surgery
- vestibulo-ocular reflex gain :
- on pathological side > 0.50
- on healthy side > 0.80
- all information's concerning the study given more than 15 days before surgery and consent collected the day before surgery
Who cannot join
- Radiotherapy treatment prior to surgery.
- Resumption of surgery
- Presence of bilateral vestibular schwannomas
- Normal or Corrected to normal distance visual acuity < 5/10
- Presence of other aetiologies that may explain the ataxic syndrome and/or oscillopsias
- Oculomotor paralysis, ocular instability in primary position
Show all 14Show fewer
- Use of medications that compromise eye movement (psychotropic drugs)
- Cervical spinal pathology with instability (contraindication for vHIT)
- Cochlear implantation
- Non-stabilized medical condition
- Pregnant women. This exclusion criterion will be investigated by questioning the patient.
- Patient under guardianship
- Patient not affiliated to a social security scheme
- Patient participating any other interventional study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
HERMANN RH Ruben, MD contact
France1 site, 1 recruiting
- Recruiting
Pierre Wertheimer Hospital - Neurological Hospital
Bron, 69677
LAGADEC VINCENT, 00336.43.53.77.13, Vincent.lagadec@chu-lyon.fr
About this study
The vestibulo-ocular reflex (VOR) induces a compensatory movement in the eye when the head is rotated, to maintain stable vision when we move. It originates in the peripheral vestibular system, which detects head movements. It is particularly effective for rapid head movements, as tested in the Head Impulse Test (HIT). In acute unilateral vestibular deficit (AUVD), the VOR deficit is compensated for by a substitution saccade, more commonly known as catch up saccade, that contribute to refocus the gaze and maintain vision during head rotations.
Recent technological advances have made it possible to make high-quality recordings during HIT (video Head Impulse Test, vHIT), leading to the identification of substitution saccades of variable latency. Our team has shown that saccades of shorter latency lead to better visual function (Hermann et al., 2017) and that the cerebellum is involved in the development of these saccades (Hermann et al., 2023), suggesting a learning effect rather than the de novo appearance of particular saccades.
Read more
The main hypothesis of this study is that the mechanisms underlying short-latency substitution saccades, which seems to guarantee good functional recovery, depend on learning occurring from the first days after an acute unilateral vestibular deficit. We also hypothesise that early physiotherapeutic rehabilitation of the VOR under Head Impulse Test conditions would promote this learning process and the development of early catch-up saccades.
One of the causes of AVD is the resection of cochleovestibular schwannomas. This procedure involves a neurotomy, i.e. complete vestibular deafferentation, which is precisely known due to the scheduled nature of the surgery. The exact moment of onset of vestibular damage is therefore known, unlike other vestibular pathologies. Hospitalisation is necessary in the immediate aftermath of surgery, with the presence of physiotherapists on the wards. In addition, there is no spontaneous recovery of the vestibular deficit. These patients therefore represent the ideal acute unilateral vestibular deficit model for testing our hypothesis. Two studies using vHIT in the aftermath of vestibular schwannoma resection surgery (Pogson et al. 2022; Mantokoudis et al. 2014) also allow us to confirm the safety and feasibility of our protocol in this patient population.
- Being tested
- Experimental treatment: Head movements, Sham treatment: only eye movements
- Keywords
- Vestibular rehabilitation, Vestibular schwannoma, Vestibulo-ocular Reflex (VOR), video Head Impulse Test (vHIT)
- Medical subject headings
- Neuroma, Acoustic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental treatment: Head movementsProcedure or surgery
Also called Head movements
These are gaze stabilisation exercises under vHIT control, between post-operative days 1 to 6.
The patient sits facing a wall 2 metres away. The investigator places the vHIT device on the participant's head and ensures that it fits properly.
This is followed by an initial calibration phase (the patient must follow a laser dot with his eyes).
Then comes stimulation phase: the investigator, standing behind the patient, places his hands on the sides of the patient's lower jaw, which he is asked to clench. The investigator asks the subject to stare at a visual target on the wall in front of the patient. The investigator then performs a series of low-amplitude, high-speed head movements in the plane of the lateral canals and on the side of the vestibular deficit.
The patient is encouraged to resume fixation of the visual target as quickly as possible.
For each treatment session, patients should perform a minimum of 10 impulses and a maximum of 30 impulses on the deafferented side. Each
Sham treatment: only eye movementsProcedure or surgery
These are visually guided saccade exercises under vHIT device control but without head movements (saccade module), between post-operative days 1 to 6.
For this sham treatment, the modalities are identical to the experimental treatment session, up to the calibration phase described above.
For the stimulation phase, the investigator, standing behind the patient, places his hands on the sides of the patient's lower jaw, which he is asked to clench. The investigator asks the subject to stare at a visual target on the wall in front of the patient. The target then jumps horizontally to trigger visually guided saccades or slides horizontally to trigger an eye-tracking movement. The investigator stabilises the patient's head to prevent any head movement. The patient is encouraged to resume or maintain fixation of the visual target as quickly as possible.
A minimum of 5 horizontal saccade sequences and 5 horizontal eye-tracking sequences will be performed. Each training session lasts approxi
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Participants included in this group will undergo experimental treatment as described below.
Head movements Receives: Procedure: Experimental treatment: Head movements |
| Control Group | Sham comparator | Participants included in this group will undergo sham-treatment as described below.
Eye movements without head movements Receives: Procedure: Sham treatment: only eye movements |
What is being measured
The primary outcome is the main question the study is designed to answer.
First Substitution Saccade Latency after treatment
Mean latencies (in milliseconds) of the first substitution saccade assessed by vHIT examination, in both groups.
Eye movements are recorded during the vHIT examination, carried out by one of the expert practitioners (physiotherapist or doctor) investigating the study. Data from the vHIT are extracted, enabling offline analysis of oculomotor parameters, including the latency of the first substitution saccade in milliseconds. These analyses are carried out off-line by the principal investigator, who was trained and experienced in this type of analysis, using software that allowed standardised and automated analysis, blinded to the group.
Measured: Day 7
Secondary outcomes (6)
First Substitution Saccade Latency during the First Week
Mean latencies (in milliseconds) of the first substitution saccade assessed by vHIT examination, in the experimental group.
This secondary outcome measure is analysed using the same method described for Main Outcome
Measured: Everyday from post-surgery Day 1 to Day 6
First Saccade Latency after treatment (follow-up)
Mean latencies (in milliseconds) of the first substitution saccade assessed by vHIT examination, for both groups
This secondary outcome measure is analysed using the same method described for Main Outcome
Measured: At post-surgery Day 45 and 3rd month
First saccades amplitude after treatment
Mean amplitudes (degrees) of the first substitution saccade assessed by vHIT examination, in both groups.
Eye movements are recorded during the vHIT examination, carried out by one of the expert practitioners (physiotherapist or doctor) investigating the study. Data from the vHIT are extracted, enabling offline analysis of oculomotor parameters, including the amplitude of the first substitution saccade in milliseconds. These analyses are carried out off-line by the principal investigator, who was trained and experienced in this type of analysis, using software that allowed standardised and automated analysis, blinded to the group.
Measured: Post surgery Day 7, Day 45 and 3rd month
First saccades amplitude during first week
Mean amplitudes (degrees) of the first substitution saccade assessed by vHIT examination, in the experimental group
This secondary outcome measure is analysed using the same method described for Main Outcome.
Measured: Everyday from post-surgery Day 1 to Day 6
Balance and gait assessment
Score of the modified Dynamic Gait index (m-DGI), in both groups.
Measured: At Day -1 (pre-surgery), and post-surgery Day 7, Day 45 and 3rd Month
Quality of Life Assessment
Score of the self administered Dizziness handicap Inventory (DHI), in both groups.
Measured: At Day -1 (pre-surgery), and post-surgery Day 7, Day 45 and 3rd Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start13 May 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular SchwannomaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Exploratory, single-centre, randomised, sham-controlled, single-blind, superiority study, with comparison of two groups.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660082
- Sponsor's protocol ID
- 69HCL24_0718
- Other IDs
- 2024-A02268-39
- Acronym
- KINE HIT
- Status last verified
- May 2025
- First submitted
- 24 Oct 2024
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Rehabilitation Using Head Impulse Test for Acute Vestibular Deficit
- ClinicalTrials.gov ID
- NCT06660082
- Acronym / sponsor ID
- KINE HIT / 69HCL24_0718
- Keywords
- Vestibular rehabilitation, Vestibular schwannoma, Vestibulo-ocular Reflex (VOR), video Head Impulse Test (vHIT)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 13 May 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 26 Oct 2024 (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.
The vestibulo-ocular reflex (VOR) induces a compensatory movement in the eye when the head is rotated, to maintain stable vision when we move. It originates in the peripheral vestibular system, which detects head movements. It is particularly effective for rapid head movements, as tested in the Head Impulse Test (HIT). In acute unilateral vestibular deficit (AUVD), the VOR deficit is compensated for by a substitution saccade, more commonly known as catch up saccade, that contribute to refocus the gaze and maintain vision during head rotations.
Recent technological advances have made it possible to make high-quality recordings during HIT (video Head Impulse Test, vHIT), leading to the identification of substitution saccades of variable latency. Our team has shown that saccades of shorter latency lead to better visual function (Hermann et al., 2017) and that the cerebellum is involved in the development of these saccades (Hermann et al., 2023), suggesting a learning effect rather than the de novo appearance of particular saccades.
The main hypothesis of this study is that the mechanisms underlying short-latency substitution saccades, which seems to guarantee good functional recovery, depend on learning occurring from the first days after an acute unilateral vestibular deficit. We also hypothesise that early physiotherapeutic rehabilitation of the VOR under Head Impulse Test conditions would promote this learning process and the development of early catch-up saccades.
One of the causes of AVD is the resection of cochleovestibular schwannomas. This procedure involves a neurotomy, i.e. complete vestibular deafferentation, which is precisely known due to the scheduled nature of the surgery. The exact moment of onset of vestibular damage is therefore known, unlike other vestibular pathologies. Hospitalisation is necessary in the immediate aftermath of surgery, with the presence of physiotherapists on the wards. In addition, there is no spontaneous recovery of the vestibular deficit. These patients therefore represent the ideal acute unilateral vestibular deficit model for testing our hypothesis. Two studies using vHIT in the aftermath of vestibular schwannoma resection surgery (Pogson et al. 2022; Mantokoudis et al. 2014) also allow us to confirm the safety and feasibility of our protocol in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Exploratory, single-centre, randomised, sham-controlled, single-blind, superiority study, with comparison of two groups.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Procedure: Experimental treatment: Head movementsParticipants included in this group will undergo experimental treatment as described below. Head movements |
| Control Group | Sham comparator | Procedure: Sham treatment: only eye movementsParticipants included in this group will undergo sham-treatment as described below. Eye movements without head movements |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients with unilateral vestibular schwannoma and programmed surgery
- vestibulo-ocular reflex gain :
- all information's concerning the study given more than 15 days before surgery and consent collected the day before surgery
Key exclusion criteria (14 listed)
- Radiotherapy treatment prior to surgery.
- Resumption of surgery
- Presence of bilateral vestibular schwannomas
- Normal or Corrected to normal distance visual acuity < 5/10
- Presence of other aetiologies that may explain the ataxic syndrome and/or oscillopsias
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 |
|---|---|---|
| Experimental treatment: Head movementsAlso: Head movementsThese are gaze stabilisation exercises under vHIT control, between post-operative days 1 to 6. The patient sits facing a wall 2 metres away. The investigator places the vHIT device on the participant's head and ensures that it fits properly. This is followed by an initial calibration phase (the patient must follow a laser dot with his eyes). Then comes stimulation phase: the investigator, standing behind the patient, places his hands on the sides of the patient's lower jaw, which he is asked to clench. The investigator asks the subject to stare at a visual target on the wall in front of the patient. The investigator then performs a series of low-amplitude, high-speed head movements in the plane of the lateral canals and on the side of the vestibular deficit. The patient is encouraged to resume fixation of the visual target as quickly as possible. For each treatment session, patients should perform a minimum of 10 impulses and a maximum of 30 impulses on the deafferented side. Each | Procedure or surgery | Experimental Group |
| Sham treatment: only eye movementsThese are visually guided saccade exercises under vHIT device control but without head movements (saccade module), between post-operative days 1 to 6. For this sham treatment, the modalities are identical to the experimental treatment session, up to the calibration phase described above. For the stimulation phase, the investigator, standing behind the patient, places his hands on the sides of the patient's lower jaw, which he is asked to clench. The investigator asks the subject to stare at a visual target on the wall in front of the patient. The target then jumps horizontally to trigger visually guided saccades or slides horizontally to trigger an eye-tracking movement. The investigator stabilises the patient's head to prevent any head movement. The patient is encouraged to resume or maintain fixation of the visual target as quickly as possible. A minimum of 5 horizontal saccade sequences and 5 horizontal eye-tracking sequences will be performed. Each training session lasts approxi | Procedure or surgery | Control Group |
Primary outcome
First Substitution Saccade Latency after treatment
Time frame: Day 7
Mean latencies (in milliseconds) of the first substitution saccade assessed by vHIT examination, in both groups. Eye movements are recorded during the vHIT examination, carried out by one of the expert practitioners (physiotherapist or doctor) investigating the study. Data from the vHIT are extracted, enabling offline analysis of oculomotor parameters, including the latency of the first substitution saccade in milliseconds. These analyses are carried out off-line by the principal investigator, who was trained and experienced in this type of analysis, using software that allowed standardised and automated analysis, blinded to the group.
6 secondary outcomes
First Substitution Saccade Latency during the First Week
Time frame: Everyday from post-surgery Day 1 to Day 6
First Saccade Latency after treatment (follow-up)
Time frame: At post-surgery Day 45 and 3rd month
First saccades amplitude after treatment
Time frame: Post surgery Day 7, Day 45 and 3rd month
First saccades amplitude during first week
Time frame: Everyday from post-surgery Day 1 to Day 6
Balance and gait assessment
Time frame: At Day -1 (pre-surgery), and post-surgery Day 7, Day 45 and 3rd Month
Quality of Life Assessment
Time frame: At Day -1 (pre-surgery), and post-surgery Day 7, Day 45 and 3rd Month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: No
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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.
HERMANN RH Ruben, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental treatment: Head movements in people with Vestibular Schwannoma and Unilateral Vestibular Deficit, run by Hospices Civils de Lyon at 1 site in France.
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 5 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LAGADEC VL VINCENT (0033643537713, Vincent.lagadec@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First Substitution Saccade Latency after treatment (time frame: Day 7). 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 16 May 2025.