Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06609044
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
Long-term Impact of NMDAR Encephalitis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Social and Psychological Long-term Impact of NMDA Receptor Encephalitis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAPIENCE2
Brief Summary:
NMDA receptor antibody encephalitis is a rare autoimmune neurological disease of the central nervous system with an estimated incidence of 15 people per million per year Patients with anti-NMDAR encephalitis experience an acute phase of the disease characterized by psychosis memory loss seizures autonomic nervous system instability or coma Since the discovery of this disease 14 years ago by Prof Dalmau the clinical presentation of the acute phase has been well characterized while the psychosocial impact of the disease remains largely unexplored
Currently there are few cohort studies of patients that have identified persistent cognitive impairment as a factor impacting remission after the acute phase Given the scarcity of information concerning the post-acute phase it is therefore essential to determine the long-term social and psychological outcomes and their daily effects on the social and functional life of this severe disease This is especially important as the patients are young with a median age of 21 years and may face lasting limitations potentially detrimental to their success in professional educational or social environments
Currently there are few cohort studies of patients that have identified persistent cognitive impairment as a factor impacting remission after the acute phase Given the scarcity of information concerning the post-acute phase it is therefore essential to determine the long-term social and psychological outcomes and their daily effects on the social and functional life of this severe disease This is especially important as the patients are young with a median age of 21 years and may face lasting limitations potentially detrimental to their success in professional educational or social environments
Detailed Description:
This study will help improve the management of patients with anti-NMDAR encephalitis
By providing the first assessment of long-term cognitive psychological and social consequences
By characterizing the patients journey through the disease
By developing a standardized neuropsychological assessment which will improve the assessment of the patient in the post-acute phase As well as improving patient care in the long term through the drafting of specific medical recommendations
By providing the first assessment of long-term cognitive psychological and social consequences
By characterizing the patients journey through the disease
By developing a standardized neuropsychological assessment which will improve the assessment of the patient in the post-acute phase As well as improving patient care in the long term through the drafting of specific medical recommendations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None