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Functional Link Between Hippocampal and Vestibular Systems: a Pilot Study in Epilepsy Surgery (HIPPOCAMPE)
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Purpose
| Condition | Intervention |
|---|---|
| Epilepsy | Other: vestibular test before and after hippocampal surgery |
| Study Type: | Interventional |
| Study Design: | 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 |
- 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
- 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
| Enrollment: | 22 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | October 2017 |
| Primary Completion Date: | November 2016 (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
|
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) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01285921
| France | |
| Hôpital BEAUJON | |
| Clichy, France, 92110 | |
| 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 ( Other Identifier: IDRCB ) |
| Study First Received: | January 27, 2011 |
| Last Updated: | April 13, 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 |
ClinicalTrials.gov processed this record on September 21, 2017