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

NCT01285921 | Completed

• 2 other identifiers: P1001062010-A01220-39
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Keywords

hippocampal; vestibular test

Outcome Measures

Primary Outcomes (1)

• caloric test

  -Caloric test (testing lateral semicircular function at low frequency). Results: Canal paresis in % and SPV in °/S

  6 months after surgery

Secondary Outcomes (1)

• vestibular test

  6 months after surgery

Study Arms (1)

hippocampal surgery

EXPERIMENTAL

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

Interventions

vestibular test before and after hippocampal surgery OTHER

* 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

hippocampal surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History of cochlea-vestibular disorder
• Pregnancy

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital BEAUJON

Clichy, 92110, France

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Elizabeth Vitte, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2011
• First Posted: January 28, 2011
• Study Start: February 1, 2011
• Primary Completion: November 1, 2016
• Study Completion: October 1, 2017
• Last Updated: November 7, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)