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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01285921
First received: January 27, 2011
Last updated: May 17, 2016
Last verified: May 2016
History of Changes
  Purpose
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 Intervention
Epilepsy
 Other: vestibular test before and after hippocampal surgery

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Functional Link Between Hippocampal and Vestibular Systems: a Pilot Study in Epilepsy Surgery Principal Investigator: Elizabeth VITTE

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • caloric test [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
    -Caloric test (testing lateral semicircular function at low frequency). Results: Canal paresis in % and SPV in °/S


Secondary Outcome Measures:
  • vestibular test [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
    • 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
Enrollment: 22
Study Start Date: February 2011
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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?
  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01285921     History of Changes
Other Study ID Numbers: P100106  2010-A01220-39 
Study First Received: January 27, 2011
Last Updated: May 17, 2016
Health Authority: France: Ministry of Health
Individual Participant Data  
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

ClinicalTrials.gov processed this record on September 27, 2016