EpilepsyHIPPOCAMPENCT01285921
Functional Link Between Hippocampal and Vestibular Systems: a Pilot Study in Epilepsy Surgery
A study testing vestibular test before and after hippocampal surgery in people with Epilepsy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- vestibular test before and after hippocampal surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2011to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of cochlea-vestibular disorder
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Link Between Hippocampal and Vestibular Systems: a Pilot Study in Epilepsy Surgery Principal Investigator: Elizabeth VITTE
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.
Read the 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?
- Conditions
- Epilepsy
- Being tested
- vestibular test before and after hippocampal surgery
- Keywords
- hippocampal, vestibular test
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vestibular test before and after hippocampal surgeryOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: vestibular test before and after hippocampal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
caloric test
-Caloric test (testing lateral semicircular function at low frequency). Results: Canal paresis in % and SPV in °/S
Measured: 6 months after surgery
Secondary outcomes (1)
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
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionNov 2016
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Vitte, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01285921
- Sponsor's protocol ID
- P100106
- Other IDs
- 2010-A01220-39
- Acronym
- HIPPOCAMPE
- Status last verified
- Nov 2017
- First submitted
- 27 Jan 2011
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Link Between Hippocampal and Vestibular Systems: a Pilot Study in Epilepsy Surgery Principal Investigator: Elizabeth VITTE
- ClinicalTrials.gov ID
- NCT01285921
- Acronym / sponsor ID
- HIPPOCAMPE / P100106
- Conditions
- Epilepsy
- Keywords
- hippocampal, vestibular test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Nov 2016 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 28 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hippocampal surgery | Experimental | Other: vestibular test before and after hippocampal surgeryVestibular 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (2 listed)
- History of cochlea-vestibular disorder
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | hippocampal surgery |
Primary outcome
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
1 secondary outcome
vestibular test
Time frame: 6 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Vitte, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vestibular test before and after hippocampal surgery in people with Epilepsy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
caloric test (time frame: 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2017.