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Clinical Trials/NCT06660082
NCT06660082
Recruiting
Not Applicable

Early Rehabilitation Using Head Impulse Test for Acute Vestibular Deficit

Hospices Civils de Lyon1 site in 1 country26 target enrollmentMay 13, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Hospices Civils de Lyon
Enrollment
26
Locations
1
Primary Endpoint
First Substitution Saccade Latency after treatment
Status
Recruiting
Last Updated
11 months ago

Overview

Brief 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. 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.

Registry
clinicaltrials.gov
Start Date
May 13, 2025
End Date
May 2027
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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
  • Use of medications that compromise eye movement (psychotropic drugs)
  • Cervical spinal pathology with instability (contraindication for vHIT)
  • Cochlear implantation
  • Non-stabilized medical condition

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • First Substitution Saccade Latency during the First Week(Everyday from post-surgery Day 1 to Day 6)
  • First Saccade Latency after treatment (follow-up)(At post-surgery Day 45 and 3rd month)
  • First saccades amplitude after treatment(Post surgery Day 7, Day 45 and 3rd month)
  • First saccades amplitude during first week(Everyday from post-surgery Day 1 to Day 6)
  • Balance and gait assessment(At Day -1 (pre-surgery), and post-surgery Day 7, Day 45 and 3rd Month)
  • Quality of Life Assessment(At Day -1 (pre-surgery), and post-surgery Day 7, Day 45 and 3rd Month)

Study Sites (1)

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