Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06433583
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-05-23
Brief Title:
Pilot Study on the Acceptability of Auricular Vagus Nerve Neurostimulation in Adolescents
Sponsor:
Centre Hospitalier Régional Metz-Thionville
Organization:
Centre Hospitalier Régional Metz-Thionville
Study Overview
Official Title:
Pilot Study on the Acceptability of Auricular Vagus Nerve Neurostimulation for the Prevention of Non-suicidal Self-injury Recurrence in Adolescents
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NEUROMUTE
Brief Summary:
Non-suicidal self-injury NSSI are acts defined by the DSM-5 Diagnostic and Statistical Manual of Mental Disorders 5 as intentional and deliberate occurring outside a psychotic state and directly causing moderate injury
Their international prevalence is between 13 and 17 in adolescents and young adults and has recently increased with the COVID-19 health crisis with the prevalence of NSSI rising to 40 in adolescents Access to psychiatrists is declining Drug solutions meanwhile lack scientific proof in this indication
The autonomic nervous system and the hypothalamo-hypophyseal axis are involved in the human response to experimentally-induced pain as well as in stress regulation notably via control of cortisol secretion
Abnormally low levels of the latter hormone have been detected in persons with NSSI disorder
Transcutaneous neurostimulation of the atrial vagus nerve taVNS has been studied for some ten years The afferent branches of the vagus nerve stimulate the hypothalamic-pituitary axis leading to the production of cortisol by the adrenals
The hypothesis of this research is that stimulation of the vagus nerve by taVNS would improve the functioning of the hypothalamic-pituitary axis in patients with NSSI and thus reduce the frequency of acting out
Although taVNS is an easy-to-access technique that patients can implement at home the question of adherence to this treatment in adolescents has not yet been evaluated The aim of this pilot study is to assess whether adolescents with NSSI will adhere to taVNS treatment
Their international prevalence is between 13 and 17 in adolescents and young adults and has recently increased with the COVID-19 health crisis with the prevalence of NSSI rising to 40 in adolescents Access to psychiatrists is declining Drug solutions meanwhile lack scientific proof in this indication
The autonomic nervous system and the hypothalamo-hypophyseal axis are involved in the human response to experimentally-induced pain as well as in stress regulation notably via control of cortisol secretion
Abnormally low levels of the latter hormone have been detected in persons with NSSI disorder
Transcutaneous neurostimulation of the atrial vagus nerve taVNS has been studied for some ten years The afferent branches of the vagus nerve stimulate the hypothalamic-pituitary axis leading to the production of cortisol by the adrenals
The hypothesis of this research is that stimulation of the vagus nerve by taVNS would improve the functioning of the hypothalamic-pituitary axis in patients with NSSI and thus reduce the frequency of acting out
Although taVNS is an easy-to-access technique that patients can implement at home the question of adherence to this treatment in adolescents has not yet been evaluated The aim of this pilot study is to assess whether adolescents with NSSI will adhere to taVNS treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None