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

This study is currently recruiting participants.

Verified February 2013 by Assistance Publique - Hôpitaux de Paris

Sponsor:

Information provided by (Responsible Party):

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT01285921

First received: January 27, 2011

Last updated: February 13, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

January 27, 2011

Last Updated Date

February 13, 2013

Start Date ^ICMJE

February 2011

Estimated Primary Completion Date

February 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01285921 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Functional Link Between Hippocampal and Vestibular Systems: a Pilot Study in Epilepsy Surgery Principal Investigator: Elizabeth VITTE

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

20 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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic

Condition ^ICMJE

Epilepsy

Intervention ^ICMJE

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

Other Name: vestibular test before and after hippocampal surgery

Study Arm (s)

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)

Intervention: Other: vestibular test before and after hippocampal surgery

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

April 2015

Estimated Primary Completion Date

February 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Elizabeth VITTE, MD, PhD

+33 (0)1 4087 58 54

elizabeth.vitte@bjn.aphp.fr

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01285921

Other Study ID Numbers ^ICMJE

P100106, 2010-A01220-39

Has Data Monitoring Committee

Responsible Party

Assistance Publique - Hôpitaux de Paris

Study Sponsor ^ICMJE

Assistance Publique - Hôpitaux de Paris

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Elizabeth Vitte, MD, PhD

Assistance Publique - Hôpitaux de Paris

Information Provided By

Assistance Publique - Hôpitaux de Paris

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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