Functional Link Between Hippocampal and Vestibular Systems: a Pilot Study in Epilepsy Surgery (HIPPOCAMPE)
Primary Purpose
Epilepsy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
vestibular test before and after hippocampal surgery
Sponsored by
About this trial
This is an interventional diagnostic trial for Epilepsy focused on measuring hippocampal, vestibular test
Eligibility 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
Sites / Locations
- Hôpital BEAUJON
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
hippocampal surgery
Arm Description
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)
Outcomes
Primary Outcome Measures
caloric test
-Caloric test (testing lateral semicircular function at low frequency). Results: Canal paresis in % and SPV in °/S
Secondary Outcome Measures
vestibular test
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
Full Information
NCT ID
NCT01285921
First Posted
January 27, 2011
Last Updated
November 3, 2017
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT01285921
Brief Title
Functional Link Between Hippocampal and Vestibular Systems: a Pilot Study in Epilepsy Surgery
Acronym
HIPPOCAMPE
Official Title
Functional Link Between Hippocampal and Vestibular Systems: a Pilot Study in Epilepsy Surgery Principal Investigator: Elizabeth VITTE
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
hippocampal, vestibular test
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hippocampal surgery
Arm Type
Experimental
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
vestibular test before and after hippocampal surgery
Intervention Description
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
Primary Outcome Measure Information:
Title
caloric test
Description
-Caloric test (testing lateral semicircular function at low frequency). Results: Canal paresis in % and SPV in °/S
Time Frame
6 months after surgery
Secondary Outcome Measure Information:
Title
vestibular test
Description
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
Time Frame
6 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Vitte, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital BEAUJON
City
Clichy
ZIP/Postal Code
92110
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Functional Link Between Hippocampal and Vestibular Systems: a Pilot Study in Epilepsy Surgery
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