新しいPTSD治療薬がFDAのブレークスルー指定につながる(Research from Georgia Tech and Emory University Leads to FDA Breakthrough Designation for New PTSD Treatment)

2022-03-03 ジョージア工科大学

<関連情報>

• https://research.gatech.edu/research-georgia-tech-and-emory-university-leads-fda-breakthrough-designation-new-ptsd-treatment
• https://www.sciencedirect.com/science/article/pii/S2666915321001165#bbib0078

心的外傷後ストレス障害(PTSD)患者における経皮的頸部迷走神経刺激法。PTSD症状およびストレスに対するインターロイキン-6反応に対する効果に関するパイロットスタディ Transcutaneous Cervical Vagal Nerve Stimulation in Patients with Posttraumatic Stress Disorder (PTSD): A Pilot Study of Effects on PTSD Symptoms and Interleukin-6 Response to Stress

J. DouglasBremner^abcMatthew T.Wittbrodt^aNil Z.Gurel^dMdMobashir H.Shandhi^dAsim H.Gazi^dYunshenJiao^eOleksiy M.Levantsevych^eMinxuanHuang^eJoyBeckwith^aIsaiasHerring^aNancyMurrah^eEmily G.Driggers^aeYi-AnKo^fMhmtJamil L.Alkhalaf^eMajdSoudan^eLucyShallenberger^eAllison N.Hankus^eJonathon A.Nye^b…Omer T.Inan^dk

https://doi.org/10.1016/j.jadr.2021.100190Get rights and content

Journal of Affective Disorders Reports, Volume 6, December 2021, Pages 100274

Abstract:

Background
Posttraumatic stress disorder (PTSD) is a highly disabling condition associated with alterations in multiple neurobiological systems, including increases in inflammatory and sympathetic function, responsible for maintenance of symptoms. Treatment options including medications and psychotherapies have limitations. We previously showed that transcutaneous Vagus Nerve Stimulation (tcVNS) blocks inflammatory (interleukin (IL)-6) responses to stress in PTSD. The purpose of this study was to assess the effects of tcVNS on PTSD symptoms and inflammatory responses to stress.

Methods
Twenty patients with PTSD were randomized to double blind active tcVNS (N=9) or sham (N=11) stimulation in conjunction with exposure to personalized traumatic scripts immediately followed by active or sham tcVNS and measurement of IL-6 and other biomarkers of inflammation. Patients then self administered active or sham tcVNS twice daily for three months. PTSD symptoms were measured with the PTSD Checklist (PCL) and the Clinician Administered PTSD Scale (CAPS), clinical improvement with the Clinical Global Index (CGI) and anxiety with the Hamilton Anxiety Scale (Ham-A) at baseline and one-month intervals followed by a repeat of measurement of biomarkers with traumatic scripts. After three months patients self treated with twice daily open label active tcVNS for another three months followed by assessment with the CGI.

Results
Traumatic scripts increased IL-6 in PTSD patients, an effect that was blocked by tcVNS (p<.05). Active tcVNS treatment for three months resulted in a 31% greater reduction in PTSD symptoms compared to sham treatment as measured by the PCL (p=0.013) as well as hyperarousal symptoms and somatic anxiety measured with the Ham-A p<0.05). IL-6 increased from baseline in sham but not tcVNS. Open label tcVNS resulted in improvements measured with the CGI compared to the sham treatment period p<0.05).

Conclusions
These preliminary results suggest that tcVNS reduces inflammatory responses to stress, which may in part underlie beneficial effects on PTSD symptoms.