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Pilot Study on the Acceptability of Auricular Vagus Nerve Neurostimulation in Adolescents

Study acronym: NEUROMUTE
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Site contact updatedv6
  2. Notable Trial status: Not Yet Recruiting to Recruitingv5 Show 4 more changesShow less
    • Primary completion date: Oct 18, 2026 to May 28, 2027
    • Study completion date: Mar 18, 2027 to May 28, 2027
    • Start date changed from estimate of Sep 18, 2024 to Nov 28, 2024
    • Site details revised
  3. Notable Start date: Jun 18, 2024 to Sep 18, 2024
    • Primary completion date: Jun 18, 2026 to Oct 18, 2026
    • Study completion date: Dec 18, 2026 to Mar 18, 2027
    v4
  4. Minor Primary completion date: Jun 15, 2026 to Jun 18, 2026
    • Study completion date: Dec 15, 2026 to Dec 18, 2026
    • Start date: Jun 15, 2024 to Jun 18, 2024
    v3
  5. Minor Secondary endpoints: details revised at 1 of 5 entriesv2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06433583
Lead Sponsor Centre Hospitalier Régional Metz-Thionville
Conditions
(from sponsor)
Psychiatric Disorder
Related terms Mental Disorders, Self-Injurious Behavior
Enrollment 22 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov