Early Rehabilitation Using Head Impulse Test for Acute Vestibular Deficit

NCT06660082 | Recruiting

• 2 other identifiers: 69HCL24_07182024-A02268-39
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Vestibular Schwannoma; Unilateral Vestibular Deficit

Keywords

Vestibular rehabilitation; Vestibular schwannoma; Vestibulo-ocular Reflex (VOR); video Head Impulse Test (vHIT)

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 7

Secondary Outcomes (6)

• 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

Study Arms (2)

Experimental Group

EXPERIMENTAL

Participants included in this group will undergo experimental treatment as described below. Head movements

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

Procedure: Sham treatment: only eye movements

Interventions

Experimental treatment: Head movements PROCEDURE

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

Also known as: Head movements

Experimental Group

Sham treatment: only eye movements PROCEDURE

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

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Patient under guardianship
• Patient not affiliated to a social security scheme
• Patient participating any other interventional study

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Pierre Wertheimer Hospital - Neurological Hospital

Bron, 69677, France

RECRUITING

MeSH Terms

Conditions

Neuroma, Acoustic

Interventions

Head Movements

Condition Hierarchy (Ancestors)

Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Cranial Nerve Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Peripheral Nervous System Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

LAGADEC VL VINCENT

CONTACT

0033643537713; Vincent.lagadec@chu-lyon.fr

HERMANN RH Ruben, MD

CONTACT

ruben.hermann@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will not be aware of the experimental or sham status of the arm they'll be allocated to. Investigator realising offline analysis will not know the arm of allocation of the subject they are analysing.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Exploratory, single-centre, randomised, sham-controlled, single-blind, superiority study, with comparison of two groups.

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 26, 2024
• Study Start: May 13, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)