Spatial Orientation, Navigation, and Neuropsychologic Function in Patients With Vestibular Implant
Vestibular Implant Tested in Patients With Peripheral Vestibular Damage: Effects on Spatial Orientation, Navigation, and Neuropsychologic Function
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
Typ studie
Typ studie
Zápis (Odhadovaný)
Zápis
Fáze
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
Studijní kontakt
- Jméno: Richard F Lewis, MD
- Telefonní číslo: 617-573- 3501
- E-mail: richard_lewis@meei.harvard.edu
Studijní záloha kontaktů
- Jméno: Faisal Karmali, PhD
- Telefonní číslo: (410) 218-7614
- E-mail: Faisal_Karmali@meei.harvard.edu
Studijní místa
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Geneva, Švýcarsko, 1211 Geneva 4
- Nábor
- Universite de Geneve
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Kontakt:
- Angelica Perez-Fornos, PhD, DAS
- Telefonní číslo: +41223728246
- E-mail: angelica.perez@unige.ch
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Kontakt:
- Guinand Nils, MD
- Telefonní číslo: +41(79)553 39 82
- E-mail: nils.guinand@hcuge.ch
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Vrchní vyšetřovatel:
- Angelica Perez-Fornos, PhD, DAS
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Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Patients receiving vestibular implants at UNIGE:
Their inclusion criteria are defined as follows:
- Deaf, scheduled for CI surgery
- Minimum of five year history of documented absence of bilateral auditory and vestibular function, based on review of their audiograms and vestibular tests.
- Vestibular testing consistent with BVL
- No neurologic disease. note: these patients are recruited and implanted by the group at the University of Geneva Hospital (UNIGE) as part of their ongoing research. The study team are not involved in any way with the decision to surgically implant patients with cochlear or vestibular implants, nor are the researchers involved in any way with pre- or post-operative clinical care. The researchers only involvement is to perform the cognitive tests before, during, and after relatively short periods of stimulation using the vestibular implant (VI)
- Vestibular patients tested at MEE: vestibular testing consistent with unilateral or bilateral vestibular damage.
Both aspects of the study share the same exclusion criteria:
Exclusion Criteria:
- No known neurologic or otologic disease other than the vestibular and auditory deficits noted above.
- Pregnancy. Pregnant women and women up to 4 months postpartum will be excluded because of the known effects and unknown potential effects of pregnancy on sensory function.
- Body weight >250 lbs (due to motion device safety limits)
- The chronic use of vestibular suppressant medication (benzodiazepine, antihistamine, anticholinergic)
- Inability to stand or walk unassisted.
- Blindness.
- Unstable medical condition.
- Orthopedic or musculoskeletal injuries/conditions that affect gait or balance.
- Ongoing neck or spinal pain/injuries or recent history of neck or spinal surgery
- Amputation, musculoskeletal deformity, or significant leg-length discrepancy
- A history of severe head trauma.
- Any major psychiatric disorder (e.g., psychosis, schizophrenia, panic disorder), not including anxiety or depression.
- Severe heart or pulmonary conditions
- Active cancer for which chemo-/radiation therapy is being received.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Singl
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
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Aktivní komparátor: "true" stimulation
tonic + motion-modulated stimulation
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Two types of stimulation are used, tonic + motion-modulated ("true") & tonic-only ("placebo") stimulation; order is randomized.
The VI stimulation period prior to testing is 12 days.
For the experiments, the VI is connected to the head-mounted prosthetic circuit and then stimulation is activated.
The stimulation unit is the current-balanced biphasic pulse, and the pulse amplitude for each subject is determined through a tuning procedure.
Experiments start with an adaptation to tonic baseline stimulation with the head stationary (~30 min).
Motion-modulated stimulation employs 3 angular velocity sensors (one aligned with the sensitive axis of each canal), the transduced head velocity signal is high-pass filtered to simulate normal canal dynamics, and filtered head velocity is used to modulate the strength (magnitude, rate) of the electrical stimulation provided by the corresponding implanted electrode.
Stimulation strength adjusts for head rotations that change canal afference.
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Falešný srovnávač: "placebo" stimulation
tonic-only stimulation
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Two types of stimulation are used, tonic + motion-modulated ("true") & tonic-only ("placebo") stimulation; order is randomized.
The VI stimulation period prior to testing is 12 days.
For the experiments, the VI is connected to the head-mounted prosthetic circuit and then stimulation is activated.
The stimulation unit is the current-balanced biphasic pulse, and the pulse amplitude for each subject is determined through a tuning procedure.
Experiments start with an adaptation to tonic baseline stimulation with the head stationary (~30 min).
Motion-modulated stimulation employs 3 angular velocity sensors (one aligned with the sensitive axis of each canal), the transduced head velocity signal is high-pass filtered to simulate normal canal dynamics, and filtered head velocity is used to modulate the strength (magnitude, rate) of the electrical stimulation provided by the corresponding implanted electrode.
Stimulation strength adjusts for head rotations that change canal afference.
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Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Spatial Orientation: Changes in Subjective Postural Vertical
Časové okno: pre-stim, chronic stim (1month + 12 days), and post-stim (1month)
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Spatial orientation (subjective postural vertical) results are assessed for their accuracy and precision.
Tests are repeated to look at changes for pre-stimulation (VI-OFF), following chronic stimulation (VI-ON), and post-stimulation (VI-OFF).
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pre-stim, chronic stim (1month + 12 days), and post-stim (1month)
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Spatial Orientation: Changes in Roll Tilt Perceptual Thresholds
Časové okno: pre-stim, chronic stim (1month + 12 days), and post-stim (1month)
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Spatial orientation (roll tilt perceptual thresholds) results are assessed for their accuracy and precision.
Tests are repeated to look at changes for pre-stimulation (VI-OFF), following chronic stimulation (VI-ON), and post-stimulation (VI-OFF).
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pre-stim, chronic stim (1month + 12 days), and post-stim (1month)
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Changes in Navigation
Časové okno: pre-stim, chronic stim (1month + 12 days), and post-stim (1month)
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Navigation in a virtual reality visual environment is tested using a 'complete the triangle' task and results are assessed for their accuracy and precision.
Tests are repeated to look at changes for pre-stimulation (VI-OFF), following chronic stimulation (VI-ON), and post-stimulation (VI-OFF).
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pre-stim, chronic stim (1month + 12 days), and post-stim (1month)
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Changes in Neuropsychologic Function
Časové okno: pre-stim, chronic stim (1month + 12 days), and post-stim (1month)
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Visuospatial and non-visuospatial neuropsychologic function are assessed using a standard battery of neuropsychologic tests.
Tests are repeated to look at changes for pre-stimulation (VI-OFF), following chronic stimulation (VI-ON), and post-stimulation (VI-OFF).
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pre-stim, chronic stim (1month + 12 days), and post-stim (1month)
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Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Spolupracovníci
Spolupracovníci
Publikace a užitečné odkazy
Obecné publikace
- Guinand N, van de Berg R, Cavuscens S, Stokroos RJ, Ranieri M, Pelizzone M, Kingma H, Guyot JP, Perez-Fornos A. Vestibular Implants: 8 Years of Experience with Electrical Stimulation of the Vestibular Nerve in 11 Patients with Bilateral Vestibular Loss. ORL J Otorhinolaryngol Relat Spec. 2015;77(4):227-240. doi: 10.1159/000433554. Epub 2015 Sep 15.
- Guinand N, van de Berg R, Ranieri M, Cavuscens S, DiGiovanna J, Nguyen TA, Micera S, Stokroos R, Kingma H, Guyot JP, Perez Fornos A. Vestibular implants: Hope for improving the quality of life of patients with bilateral vestibular loss. Annu Int Conf IEEE Eng Med Biol Soc. 2015;2015:7192-5. doi: 10.1109/EMBC.2015.7320051.
- Nguyen TAK, Cavuscens S, Ranieri M, Schwarz K, Guinand N, van de Berg R, van den Boogert T, Lucieer F, van Hoof M, Guyot JP, Kingma H, Micera S, Perez Fornos A. Characterization of Cochlear, Vestibular and Cochlear-Vestibular Electrically Evoked Compound Action Potentials in Patients with a Vestibulo-Cochlear Implant. Front Neurosci. 2017 Nov 21;11:645. doi: 10.3389/fnins.2017.00645. eCollection 2017.
- Perez Fornos A, Cavuscens S, Ranieri M, van de Berg R, Stokroos R, Kingma H, Guyot JP, Guinand N. The vestibular implant: A probe in orbit around the human balance system. J Vestib Res. 2017;27(1):51-61. doi: 10.3233/VES-170604.
- Starkov D, Guinand N, Lucieer F, Ranieri M, Cavuscens S, Pleshkov M, Guyot JP, Kingma H, Ramat S, Perez-Fornos A, van de Berg R. Restoring the High-Frequency Dynamic Visual Acuity with a Vestibular Implant Prototype in Humans. Audiol Neurootol. 2020;25(1-2):91-95. doi: 10.1159/000503677. Epub 2019 Oct 29.
- Brandt T, Schautzer F, Hamilton DA, Bruning R, Markowitsch HJ, Kalla R, Darlington C, Smith P, Strupp M. Vestibular loss causes hippocampal atrophy and impaired spatial memory in humans. Brain. 2005 Nov;128(Pt 11):2732-41. doi: 10.1093/brain/awh617. Epub 2005 Sep 1.
- Fridman GY, Della Santina CC. Progress toward development of a multichannel vestibular prosthesis for treatment of bilateral vestibular deficiency. Anat Rec (Hoboken). 2012 Nov;295(11):2010-29. doi: 10.1002/ar.22581. Epub 2012 Oct 8.
- Dai C, Fridman GY, Davidovics NS, Chiang B, Ahn JH, Della Santina CC. Restoration of 3D vestibular sensation in rhesus monkeys using a multichannel vestibular prosthesis. Hear Res. 2011 Nov;281(1-2):74-83. doi: 10.1016/j.heares.2011.08.008. Epub 2011 Aug 26.
- Chow MR, Ayiotis AI, Schoo DP, Gimmon Y, Lane KE, Morris BJ, Rahman MA, Valentin NS, Boutros PJ, Bowditch SP, Ward BK, Sun DQ, Trevino Guajardo C, Schubert MC, Carey JP, Della Santina CC. Posture, Gait, Quality of Life, and Hearing with a Vestibular Implant. N Engl J Med. 2021 Feb 11;384(6):521-532. doi: 10.1056/NEJMoa2020457.
- Hitier M, Besnard S, Smith PF. Vestibular pathways involved in cognition. Front Integr Neurosci. 2014 Jul 23;8:59. doi: 10.3389/fnint.2014.00059. eCollection 2014.
- Mast FW, Preuss N, Hartmann M, Grabherr L. Spatial cognition, body representation and affective processes: the role of vestibular information beyond ocular reflexes and control of posture. Front Integr Neurosci. 2014 May 27;8:44. doi: 10.3389/fnint.2014.00044. eCollection 2014.
- Boutros PJ, Schoo DP, Rahman M, Valentin NS, Chow MR, Ayiotis AI, Morris BJ, Hofner A, Rascon AM, Marx A, Deas R, Fridman GY, Davidovics NS, Ward BK, Trevino C, Bowditch SP, Roberts DC, Lane KE, Gimmon Y, Schubert MC, Carey JP, Jaeger A, Della Santina CC. Continuous vestibular implant stimulation partially restores eye-stabilizing reflexes. JCI Insight. 2019 Nov 14;4(22):e128397. doi: 10.1172/jci.insight.128397.
- Chari DA, Ahmad M, King S, Boutabla A, Fattahi C, Panic AS, Karmali F, Lewis RF. Vestibular damage affects the precision and accuracy of navigation in a virtual visual environment. Brain Commun. 2023 Dec 8;5(6):fcad345. doi: 10.1093/braincomms/fcad345. eCollection 2023.
- Peruch P, Borel L, Magnan J, Lacour M. Direction and distance deficits in path integration after unilateral vestibular loss depend on task complexity. Brain Res Cogn Brain Res. 2005 Dec;25(3):862-72. doi: 10.1016/j.cogbrainres.2005.09.012. Epub 2005 Oct 26.
- Bisdorff AR, Anastasopoulos D, Bronstein AM, Gresty MA. Subjective postural vertical in peripheral and central vestibular disorders. Acta Otolaryngol Suppl. 1995;520 Pt 1:68-71. doi: 10.3109/00016489509125193.
- Lewis RF. Vestibular implants studied in animal models: clinical and scientific implications. J Neurophysiol. 2016 Dec 1;116(6):2777-2788. doi: 10.1152/jn.00601.2016. Epub 2016 Oct 19.
- King S, Dahlem K, Karmali F, Stankovic KM, Welling DB, Lewis RF. Imbalance and dizziness caused by unilateral vestibular schwannomas correlate with vestibulo-ocular reflex precision and bias. J Neurophysiol. 2022 Feb 1;127(2):596-606. doi: 10.1152/jn.00725.2020. Epub 2022 Jan 26.
- Grabherr L, Cuffel C, Guyot JP, Mast FW. Mental transformation abilities in patients with unilateral and bilateral vestibular loss. Exp Brain Res. 2011 Mar;209(2):205-14. doi: 10.1007/s00221-011-2535-0. Epub 2011 Feb 2.
- Chari DA, Madhani A, Sharon JD, Lewis RF. Evidence for cognitive impairment in patients with vestibular disorders. J Neurol. 2022 Nov;269(11):5831-5842. doi: 10.1007/s00415-022-11289-3. Epub 2022 Aug 5.
- Peruch P, Borel L, Gaunet F, Thinus-Blanc G, Magnan J, Lacour M. Spatial performance of unilateral vestibular defective patients in nonvisual versus visual navigation. J Vestib Res. 1999;9(1):37-47.
- Smith PF. The vestibular system and cognition. Curr Opin Neurol. 2017 Feb;30(1):84-89. doi: 10.1097/WCO.0000000000000403.
- Xie Y, Bigelow RT, Frankenthaler SF, Studenski SA, Moffat SD, Agrawal Y. Vestibular Loss in Older Adults Is Associated with Impaired Spatial Navigation: Data from the Triangle Completion Task. Front Neurol. 2017 Apr 27;8:173. doi: 10.3389/fneur.2017.00173. eCollection 2017.
- Dobbels B, Mertens G, Gilles A, Moyaert J, van de Berg R, Fransen E, Van de Heyning P, Van Rompaey V. The Virtual Morris Water Task in 64 Patients With Bilateral Vestibulopathy and the Impact of Hearing Status. Front Neurol. 2020 Aug 11;11:710. doi: 10.3389/fneur.2020.00710. eCollection 2020.
- Ahmad M, Bola L, Boutabla A, King S, Lewis RF, Chari DA. Visuospatial Cognitive Dysfunction in Patients with Vestibular Loss. Otol Neurotol. 2022 Dec 1;43(10):e1140-e1147. doi: 10.1097/MAO.0000000000003696. Epub 2022 Oct 6.
- Zheng Y, Goddard M, Darlington CL, Smith PF. Long-term deficits on a foraging task after bilateral vestibular deafferentation in rats. Hippocampus. 2009 May;19(5):480-6. doi: 10.1002/hipo.20533.
- Muir GM, Taube JS. The neural correlates of navigation: do head direction and place cells guide spatial behavior? Behav Cogn Neurosci Rev. 2002 Dec;1(4):297-317. doi: 10.1177/1534582302238339.
- Clark TK, Newman MC, Karmali F, Oman CM, Merfeld DM. Mathematical models for dynamic, multisensory spatial orientation perception. Prog Brain Res. 2019;248:65-90. doi: 10.1016/bs.pbr.2019.04.014. Epub 2019 May 24.
- Rosenberg MJ, Galvan-Garza RC, Clark TK, Sherwood DP, Young LR, Karmali F. Human manual control precision depends on vestibular sensory precision and gravitational magnitude. J Neurophysiol. 2018 Dec 1;120(6):3187-3197. doi: 10.1152/jn.00565.2018. Epub 2018 Oct 31.
- Valko Y, Lewis RF, Priesol AJ, Merfeld DM. Vestibular labyrinth contributions to human whole-body motion discrimination. J Neurosci. 2012 Sep 26;32(39):13537-42. doi: 10.1523/JNEUROSCI.2157-12.2012.
- Karmali F, Haburcakova C, Gong W, Della Santina CC, Merfeld DM, Lewis RF. An Implanted Vestibular Prosthesis Improves Spatial Orientation in Animals with Severe Vestibular Damage. J Neurosci. 2021 Apr 28;41(17):3879-3888. doi: 10.1523/JNEUROSCI.2204-20.2021. Epub 2021 Mar 17.
- Lewis RF, Haburcakova C, Gong W, Lee D, Merfeld D. Electrical stimulation of semicircular canal afferents affects the perception of head orientation. J Neurosci. 2013 May 29;33(22):9530-5. doi: 10.1523/JNEUROSCI.0112-13.2013.
- Lewis RF, Haburcakova C, Gong W, Karmali F, Merfeld DM. Spatial and temporal properties of eye movements produced by electrical stimulation of semicircular canal afferents. J Neurophysiol. 2012 Sep;108(5):1511-20. doi: 10.1152/jn.01029.2011. Epub 2012 Jun 6.
- Lewis RF, Haburcakova C, Gong W, Makary C, Merfeld DM. Vestibuloocular reflex adaptation investigated with chronic motion-modulated electrical stimulation of semicircular canal afferents. J Neurophysiol. 2010 Feb;103(2):1066-79. doi: 10.1152/jn.00241.2009. Epub 2009 Dec 16.
- Merfeld DM, Haburcakova C, Gong W, Lewis RF. Chronic vestibulo-ocular reflexes evoked by a vestibular prosthesis. IEEE Trans Biomed Eng. 2007 Jun;54(6 Pt 1):1005-15. doi: 10.1109/TBME.2007.891943.
- Nie K, Ling L, Bierer SM, Kaneko CR, Fuchs AF, Oxford T, Rubinstein JT, Phillips JO. An experimental vestibular neural prosthesis: design and preliminary results with rhesus monkeys stimulated with modulated pulses. IEEE Trans Biomed Eng. 2013 Jun;60(6):1685-92. doi: 10.1109/TBME.2013.2241433. Epub 2013 Jan 21.
- Diaz-Artiles A, Karmali F. Vestibular Precision at the Level of Perception, Eye Movements, Posture, and Neurons. Neuroscience. 2021 Aug 1;468:282-320. doi: 10.1016/j.neuroscience.2021.05.028. Epub 2021 Jun 2.
- Hanes DA, McCollum G. Cognitive-vestibular interactions: a review of patient difficulties and possible mechanisms. J Vestib Res. 2006;16(3):75-91.
- Van Hecke R, Danneels M, Deconinck FJA, Dhooge I, Leyssens L, Van Acker E, Van Waelvelde H, Wiersema JR, Maes L. A cross-sectional study on the neurocognitive outcomes in vestibular impaired school-aged children: are they at higher risk for cognitive deficits? J Neurol. 2023 Sep;270(9):4326-4341. doi: 10.1007/s00415-023-11774-3. Epub 2023 May 20.
- Gong W, Merfeld DM. Prototype neural semicircular canal prosthesis using patterned electrical stimulation. Ann Biomed Eng. 2000 May;28(5):572-81. doi: 10.1114/1.293.
- Gong W, Merfeld DM. System design and performance of a unilateral horizontal semicircular canal prosthesis. IEEE Trans Biomed Eng. 2002 Feb;49(2):175-81. doi: 10.1109/10.979358.
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- 2025P000498
- R01DC021981 (Grant/smlouva NIH USA)
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