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Functional Link Between Hippocampal and Vestibular Systems: a Pilot Study in Epilepsy Surgery (HIPPOCAMPE)

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ClinicalTrials.gov Identifier: NCT01285921
Recruitment Status : Completed
First Posted : January 28, 2011
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief Summary:
Vestibular signals deeply influence hippocampal spatial representations and may contribute to the navigational deficits of humans with vestibular dysfunction. The reciprocal influence of hippocampal signals on the vestibular system are more putative. The investigators wish to investigate in this pilot study the consequences on vestibular system of the removal of the hippocampal formation to treat drug resistant temporal lobe epilepsy.

Condition or disease Intervention/treatment Phase
Epilepsy Other: vestibular test before and after hippocampal surgery Not Applicable

Detailed Description:

Functional link between hippocampal and vestibular systems: a pilot study in epilepsy surgery

Hypothesis:

The human hippocampal formation plays a crucial role in various aspects of memory processing. Work in rodents and some other species emphasized the role of the hippocampus in spatial learning and memory as well. A few human studies also point to a direct relation between hippocampal size, navigation and spatial memory. Patients with acquired chronic bilateral vestibular loss develop a significant selective atrophy of the hippocampus (Brandt et al, 2005) and activation of lateral semicircular canal by caloric stimulation induces activation of hippocampal formation in f-MRI (VITTE et al, 1996). But the investigators still do not know the effects on vestibular responses of the removal of the hippocampal formation to cure temporal lobe epilepsy. If the hippocampal formation directly influences the vestibular response, an asymmetry of the vestibular responses should be recorded postoperatively.

Principal criterion Research for an asymmetry of the vestibular responses (Caloric test, Vestibular Evoked Myogenic potentials: VEMp, Head Impulse Test: HIT, Eye Rotational Test: ERI)

Inclusion criteria

  • patients suffering of intractable mesial temporal lobe epilepsy and candidate for surgery,
  • without history of any cochlea-vestibular disorder
  • older than 18 years,
  • French residents,
  • with medicare,
  • after signed informed consent. Exclusion criteria
  • History of cochlea-vestibular disorder
  • Pregnancy

Population

  • 22 patients suffering of intractable epilepsy and candidate for surgery (10 right side and 10 left side).
  • Evaluation before and after surgery

Methodology Vestibular function will be quantified by daily practice vestibular tests

  • Research of a spontaneous nystagmus with and without fixation (VIDEONYSTAGMOSCOPY) and segmentary deviations (Fukuda test)
  • HIT (testing semicircular canal function at high frequency). Results: Gain in %
  • VEMp (testing saccular function). Results: Amplitude in μV and latency in ms
  • ERI (testing lateral semicircular function at middle frequency). Results: Nystagmus during and after the rotations in frequency and slow phase velocity (SPV) in °/s
  • Caloric test (testing lateral semicircular function at low frequency). Results: Canal paresis in % and SPV in °/S

Results Vestibular function will be quantified with daily practice vestibular tests

  • Quantification of the vestibular asymmetry
  • Ipsi or contralateral to the side of the surgery?
  • Depending on the hemispheric dominance?

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Functional Link Between Hippocampal and Vestibular Systems: a Pilot Study in Epilepsy Surgery Principal Investigator: Elizabeth VITTE
Study Start Date : February 2011
Actual Primary Completion Date : November 2016
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: hippocampal surgery

Vestibular test before and after hippocampal surgery

Principal criterion:

Research for an asymmetry of the vestibular responses (Caloric test, Vestibular Evoked Myogenic potentials: VEMp, Head Impulse Test: HIT, Eye Rotational Test: ERI). Investigator performs a blind vestibular test (single blind)

 Other: vestibular test before and after hippocampal surgery
  • Research of a spontaneous nystagmus with and without fixation(VIDEONYSTAGMOSCOPY) and segmentary deviations (Fukuda test)
  • HIT (testing semicircular canal function at high frequency).Results: Gain in %
  • VEMp (testing saccular function). Results: Amplitude in μV and latency in ms
  • ERI (testing lateral semicircular function at middle frequency). Results: Nystagmus during and after the rotations in frequency and slow phase velocity (SPV) in °/s
  • Caloric test (testing lateral semicircular function at low frequency). Results: Canal paresis in % and SPV in °/S


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. caloric test [ Time Frame: 6 months after surgery ]
    -Caloric test (testing lateral semicircular function at low frequency). Results: Canal paresis in % and SPV in °/S


Secondary Outcome Measures :
  1. vestibular test [ Time Frame: 6 months after surgery ]
    • Research of a spontaneous nystagmus with and without fixation(videonystagmoscopy) and segmentary deviations (Fukuda test)
    • HIT (testing semicircular canal function at high frequency). Results: Gain in %
    • VEMp (testing saccular function). Results: Amplitude in μV and latency in ms
    • ERI (testing lateral semicircular function at middle frequency). Results: Nystagmus during and after the rotations in frequency and slow phase velocity (SPV) in °/s


Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients suffering of intractable mesial temporal lobe epilepsy and candidate for surgery,
  • without history of any cochlea-vestibular disorder
  • older than 18 years,
  • French residents,
  • with medicare,
  • after signed informed consent

Exclusion Criteria:

  • History of cochlea-vestibular disorder
  • Pregnancy
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01285921


Locations
France
Hôpital BEAUJON
Clichy, France, 92110
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Study Director: Elizabeth Vitte, MD, PhD Assistance Publique - Hôpitaux de Paris
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01285921     History of Changes
Other Study ID Numbers: P100106
2010-A01220-39 ( Other Identifier: IDRCB )
First Posted: January 28, 2011    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
hippocampal
vestibular test

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases