MedDataX Logo

PET Study of the Nicotinic System in Epilepsy

NCT ID: NCT03268369

Last Updated: 2017-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2015-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Mutations in neuronal nicotinic acetylcholine receptors (nAChRs) have been identified in the autosomal dominant nocturnal frontal lobe epilepsy (ADNFLE). Despite the demonstration of a gain of function of the mutated receptors, the precise mechanisms leading to this nocturnal epilepsy are still unknown. In 2006 the investigators studied the nAChR cerebral distribution in a group of patients with ADNFLE carrying a nAChR mutation, by a PET-scan using \[18F\]-F-A-85380, a ligand with a high affinity and specificity for alpha4beta2 nicotinic receptors. The study showed a different pattern of brain distribution of the radiotracer in the ADNFLE patients when compared to a group of control subjects, with a significant increase of nicotinic receptor density in the patients in mesencephalon and cerebellum (Picard et al., Brain 2006). Based on the known biochemical and cellular circuits in the brainstem, these results suggest that the nAChR density increase in mesencephalon is involved in the pathophysiology of ADNFLE through the role of brainstem ascending cholinergic systems in arousal. The follow-up step consists of extending this examination to other forms of epilepsy, in order to verify the specificity of the hyperfixation pattern for ADNFLE, and search for a potential involvement of nicotinic receptors in other forms of epilepsy. The investigators aim to study 5 groups of subjects: control subjects (Group 1, 20 subjects); patients with a non lesional partial epilepsy and a predominance of diurnal seizures (Group 2, 12 subjects); patients with an idiopathic generalized epilepsy (Group 3, 12 subjects); patients with nocturnal frontal lobe epilepsy (Group 4, 3 subjects) and epileptic patients with vagal nerve stimulation (Group 5, 1 subject). For each patient, a cerebral MRI, \[18F\]- fluorodeoxyglucose (FDG) PET/CT and \[18F\]-F-A-85380 PET/CT examinations are planned. The investigators will perform data analyses on volume of distribution (Vt) parametric images which will be based on the ratio of brain tissue to unchanged F-A-85380 plasma at equilibrium. Statistical parametric mapping (SPM2) will be used to further study the parametric PET images. This study is primarily dedicated to demonstrate that the pattern of hyperfixation that was obtained in ADNFLE patients is specific for this disorder and does not constitute a common pattern to various forms of epilepsy. The investigators will also search for a possible involvement of the nAChRs in other forms of epilepsy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Epilepsy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

Group Type ACTIVE_COMPARATOR

MRI of the brain

Intervention Type RADIATION

to eliminate a structural intra-cerebral lesion

PET scan [18F]F-A-85380

Intervention Type RADIATION

exam performed after iv injection of 200 MBq \[18F\]F-A-85380

PET scan [18F]FDG

Intervention Type RADIATION

exam performed after iv injection of 200 MBq \[18F\]FDG

Non lesional diurnal partial epilepsy

Group Type EXPERIMENTAL

MRI of the brain

Intervention Type RADIATION

to eliminate a structural intra-cerebral lesion

PET scan [18F]F-A-85380

Intervention Type RADIATION

exam performed after iv injection of 200 MBq \[18F\]F-A-85380

PET scan [18F]FDG

Intervention Type RADIATION

exam performed after iv injection of 200 MBq \[18F\]FDG

Idiopathic generalized epilepsy

Group Type EXPERIMENTAL

MRI of the brain

Intervention Type RADIATION

to eliminate a structural intra-cerebral lesion

PET scan [18F]F-A-85380

Intervention Type RADIATION

exam performed after iv injection of 200 MBq \[18F\]F-A-85380

PET scan [18F]FDG

Intervention Type RADIATION

exam performed after iv injection of 200 MBq \[18F\]FDG

Nocturnal frontal lobe epilepsy

Group Type EXPERIMENTAL

MRI of the brain

Intervention Type RADIATION

to eliminate a structural intra-cerebral lesion

PET scan [18F]F-A-85380

Intervention Type RADIATION

exam performed after iv injection of 200 MBq \[18F\]F-A-85380

PET scan [18F]FDG

Intervention Type RADIATION

exam performed after iv injection of 200 MBq \[18F\]FDG

Epileptic patients with Vagus Nerve Stimulation (VNS)

Group Type EXPERIMENTAL

PET scan [18F]F-A-85380

Intervention Type RADIATION

exam performed after iv injection of 200 MBq \[18F\]F-A-85380

PET scan [18F]FDG

Intervention Type RADIATION

exam performed after iv injection of 200 MBq \[18F\]FDG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MRI of the brain

to eliminate a structural intra-cerebral lesion

Intervention Type RADIATION

PET scan [18F]F-A-85380

exam performed after iv injection of 200 MBq \[18F\]F-A-85380

Intervention Type RADIATION

PET scan [18F]FDG

exam performed after iv injection of 200 MBq \[18F\]FDG

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* males
* 18-60 years old
* non-smokers

Exclusion Criteria

* smoking during the past twelve months
* contraindications to MRI
* brain lesions on MRI (including hippocampal atrophy)
* neurological disorder (other than epilepsy) or psychiatric disorder
* neoplasia or coronary disease
* blood test showing : creatinine clearance \< 50 ml/min, or platelet \< 100 G/l, or leucocytes \< 3.8 G/l, or ALT or AST \> 2 x upper standard, or gamma-GT \> 3 x upper standard, or albumin \< 35 g/l or \> 48 g/l .
* patients only : nuclear imaging during the past twelve months
* healthy volunteers only : ionising radiation exam during the past five years
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fabienne PICARD

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Fabienne PICARD

Doctor, University Hospital, Geneva

Responsibility Role SPONSOR_INVESTIGATOR

References

Explore related publications, articles, or registry entries linked to this study.

Picard F, Bruel D, Servent D, Saba W, Fruchart-Gaillard C, Schollhorn-Peyronneau MA, Roumenov D, Brodtkorb E, Zuberi S, Gambardella A, Steinborn B, Hufnagel A, Valette H, Bottlaender M. Alteration of the in vivo nicotinic receptor density in ADNFLE patients: a PET study. Brain. 2006 Aug;129(Pt 8):2047-60. doi: 10.1093/brain/awl156. Epub 2006 Jun 30.

Reference Type BACKGROUND
PMID: 16815873 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

10-041

Identifier Type: -

Identifier Source: org_study_id