Amnesia Clinical Trial
Official title:
Transient Global Amnesia (TGA) Exploratory Study of the Default Mode Network in Resting State Functional MRI (fMRI) During the Acute Phase
The transient global amnesia, in which the memory disorder is massive, transient and pure,
offers a unique model for exploring episodic memory. Topographic MRI can reveal a focal and
selective lesion located on the CA1 region of the hippocampus better visible between 48h and
72h after onset of the episode.
There is therefore a real dissociation between structural lesions witch are minimal or
non-existent and the massive memory disorder. This suggests that functional impairment goes
far beyond the structural damage in this condition. To our knowledge, no study has been
performed to identify this functional impairment using resting state fMRI.
Thus, investigators wish to study the neural networks involved in memory impairment during
the acute phase of transient global amnesia using resting state imaging. This technique
appears to be modern and adapted to these patients population. Investigators hypothesize
that despite limited structural lesions, a large functional network is impaired compared to
that observed in a group of healthy subjects. investigators believe that the alteration of
the functional network will explain the depth of memory impairment observed.
The main aim of this study will be to identify functional impairment in the patient group
vs. control group during the acute phase of transient global amnesia (TGA) using resting
state imaging.
Patients potentially eligible will be informed during their arrival to the emergency unit.
If the patient is eligible and would like to participate, information will be given. For the
patients willing to participate, inclusion and exclusion criteria will be verified. Two
imaging exams (topographic MRI and resting state fMRI) and neuropsychological assessment
will be performed during three visits.
Background:
The transient global amnesia is a transient, massive and pure memory disorder. Its
pathophysiology is poorly known, but the disease process involves the Papez circuitry, and
more specifically the medial part of the temporal lobes (hippocampi). It involves 3-8 per
100,000 people per year. The age of patients affected is between 50 and 70 years. Structural
MRI can confirm the diagnosis by revealing a focal and selective lesion located on the CA1
region of the hippocampus better observed between 48h and 72h after onset of the episode.
Main purpose:
The main aim of this study is to identify neuronal functional impairment in a group of
patients vs. a group of healthy subjects during the acute phase of transient global amnesia
(TGA) using resting state fMRI imaging.
Secondary purpose:
- Show correlations between functional activity observed in resting state fMRI at the
acute phase and cognitive performance in the patient group.
- Describe the evolution of functional impairment in resting state fMRI between the acute
phase (visit 1) and post-acute phases (visit 2 and 3) in the patient group compared to
the control group subjects.
Study design:
Monocentric, pilot, prospective, controlled study including consecutive patients admitted to
the emergency department of the CHU of Toulouse for transient global amnesia. investigators
will compare two independent groups: patients and controls We expect three months between
the signing of consent and the end of the study. The total duration of the study will not
exceed 27 months.
Arm number or label and arm type: This study is exploratory. investigators will compare two
independent groups: patients and controls
Interventions:
After signing the informed consent each patient TGA will receive a neuropsychological
assessment, a topographic MRI and an evaluation in resting state fMRI during three
successive visits:
- During the acute phase within 24 hours
- In 72 hours
- In 3 months
Number of subjects:
It's difficult to estimate the number of subjects required to show a difference in resting
state between the two groups during the acute phase of TGA. No study of that type in the
literature is available to estimate the sample size to be recruited. In this pilot study we
will recruit 22 subjects in each group.
Expected benefits:
The transient global amnesia is a model for exploring memory because this disorder is
massive, pure and temporary. Better understand the Neural Network substrates underlying this
alteration could help to better understand memory disorders in other diseases (Korsakoff
syndrome, thalamic stroke, dissociative amnesia, Alzheimer's disease). Such discovery could
lead to clinical trials of functional brain stimulation as recently developed in other
neurological disorders in which functional impairment has been shown. (TMS, TDCS)
Statistical analysis:
The SPM8 software will be used to generate activation map using fMRI images. The obtained
maps will be compared between groups using t test imbedded in the same software. Correlation
maps between cognitive performance and activation will be also calculated. Intra group
comparison across time will then be assessed.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT00476528 -
Early Rehabilitation of Patients With Posttraumatic Amnesia
|
N/A | |
Completed |
NCT00400790 -
Organ Protection for Coronary Artery Bypass Graft (CABG): Propofol Versus Desflurane
|
N/A | |
Terminated |
NCT02796287 -
Longitudinal Monitoring of Cerebral Connectivity 3T MRI in Patients With a Transcient Global Amnesia
|
N/A | |
Completed |
NCT02515890 -
Memory Modulation by Pain During Anesthesia
|
Phase 1 | |
Completed |
NCT04842045 -
Pilot RECAP Study in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT02050152 -
Nitrous Oxide Induction Induces Amnesia in Pediatric Patients
|
N/A | |
Completed |
NCT05045170 -
Sedation and Memory Consolidation
|
N/A | |
Recruiting |
NCT04389437 -
OCT-Angiography and Adaptive Optics in Patients With Memory Impairment
|
N/A | |
Recruiting |
NCT06044740 -
Sevoflurane's Effect on Neurocognition Study
|
Phase 1 | |
Completed |
NCT01919775 -
Amnesia After Surgery for Anterior Communicating Aneurysm: High Resolution Magnetic Resonance (MR) Imaging Findings
|
N/A | |
Completed |
NCT00001362 -
Magnetic Resonance Imaging for the Study of Patients With Neurological Disorders
|
N/A |