- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01285921
Functional Link Between Hippocampal and Vestibular Systems: a Pilot Study in Epilepsy Surgery (HIPPOCAMPE)
Functional Link Between Hippocampal and Vestibular Systems: a Pilot Study in Epilepsy Surgery Principal Investigator: Elizabeth VITTE
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Clichy, France, 92110
- Hopital Beaujon
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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) |
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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caloric test
Time Frame: 6 months after surgery
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-Caloric test (testing lateral semicircular function at low frequency).
Results: Canal paresis in % and SPV in °/S
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6 months after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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vestibular test
Time Frame: 6 months after surgery
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6 months after surgery
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Collaborators and Investigators
Investigators
- Study Director: Elizabeth Vitte, MD, PhD, Assistance Publique - Hôpitaux de Paris
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P100106
- 2010-A01220-39 (Other Identifier: IDRCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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