Safety and Effectiveness of Transcutaneous Auricular Vagus Nerve Stimulation on Patients with Depersonalization-derealization Disorder: Study Protocol for a Randomized Controlled Trial

Overview

Journal Trials

Publisher Biomed Central

Specialties General Medicine
Pharmacology

Date 2024 Dec 5

PMID 39639403

Authors

Yan Zhao

Sisi Zheng

Hong Zhu

Dongqing Yin

Meng Fang

Hongxiao Jia

Affiliations

Soon will be listed here.

Abstract

Background: Depersonalization-derealization disorder (DPD) is a complex psychiatric condition marked by profound and often relentless feelings of detachment from one's self and surroundings. Transcranial electrical stimulation (taVNS) holds promise as a potential therapeutic approach for DPD. This study aims to investigate the safety and efficacy of taVNS in treating DPD.

Methods: DPD patients were recruited as research subjects and randomly allocated to the experimental and control groups, with the former receiving active-taVNS treatment and the latter receiving sham stimulation treatment for 6 weeks. The efficacy of taVNS in treating DPD was evaluated by comparing scores for DPD symptoms, depression and anxiety symptoms, cognitive function, and social function before and after treatment between the two groups. The safety of taVNS in treating DPD was assessed by comparing general safety assessment results between the two groups of DPD patients.

Discussion: This study will assess taVNS as a potential treatment for DPD, evaluating its safety, efficacy, and impact on patient outcomes and societal burden.

Trial Registration: Chinese Clinical Trial Registry, ChiCTR2300078183, Registered on 30 November, 2023, https://www.chictr.org.cn/showproj.html?proj=206119.

References

Medford N, Brierley B, Brammer M, Bullmore E, David A, Phillips M . Emotional memory in depersonalization disorder: a functional MRI study. Psychiatry Res. 2006; 148(2-3):93-102. DOI: 10.1016/j.pscychresns.2006.05.007. View

. Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998; 28(3):551-8. DOI: 10.1017/s0033291798006667. View

Michal M, Adler J, Wiltink J, Reiner I, Tschan R, Wolfling K . A case series of 223 patients with depersonalization-derealization syndrome. BMC Psychiatry. 2016; 16:203. PMC: 4924239. DOI: 10.1186/s12888-016-0908-4. View

Guralnik O, Giesbrecht T, Knutelska M, Sirroff B, Simeon D . Cognitive functioning in depersonalization disorder. J Nerv Ment Dis. 2007; 195(12):983-8. DOI: 10.1097/NMD.0b013e31815c19cd. View

Hunter E, Charlton J, David A . Depersonalisation and derealisation: assessment and management. BMJ. 2017; 356:j745. DOI: 10.1136/bmj.j745. View

Bout A, Berhili N, Benbrahim M, Aalouane R, Rammouz I . [Lamotrigine in the treatment of resistant depersonalization disorder: A case report]. Encephale. 2017; 44(1):85-87. DOI: 10.1016/j.encep.2017.04.003. View

Hunter E, Baker D, Phillips M, Sierra M, David A . Cognitive-behaviour therapy for depersonalisation disorder: an open study. Behav Res Ther. 2005; 43(9):1121-30. DOI: 10.1016/j.brat.2004.08.003. View

Simeon D, Stein D, Hollander E . Treatment of depersonalization disorder with clomipramine. Biol Psychiatry. 1998; 44(4):302-3. DOI: 10.1016/s0006-3223(98)00023-7. View

Xia P, Li N, Hau K, Liu C, Lu Y . Quality of life of Chinese urban community residents: a psychometric study of the mainland Chinese version of the WHOQOL-BREF. BMC Med Res Methodol. 2012; 12:37. PMC: 3364902. DOI: 10.1186/1471-2288-12-37. View

10.

Sierra M, Berrios G . The Cambridge Depersonalization Scale: a new instrument for the measurement of depersonalization. Psychiatry Res. 2000; 93(2):153-64. DOI: 10.1016/s0165-1781(00)00100-1. View

11.

Sookman D, SOLYOM L . Severe depersonalization treated by behavior therapy. Am J Psychiatry. 1978; 135(12):1543-5. DOI: 10.1176/ajp.135.12.1543. View

12.

Christopeit M, Simeon D, Urban N, Gowatsky J, Lisanby S, Mantovani A . Effects of repetitive transcranial magnetic stimulation (rTMS) on specific symptom clusters in depersonalization disorder (DPD). Brain Stimul. 2013; 7(1):141-3. DOI: 10.1016/j.brs.2013.07.006. View

13.

Simeon D, Knutelska M, Putnam F, Schmeidler J, Smith L . Attention and Memory in Depersonalization-Spectrum Dissociative Disorders: Impact of Selective-Divided Attentional Condition, Stimulus Emotionality, and Stress. J Trauma Dissociation. 2022; 24(1):42-62. DOI: 10.1080/15299732.2022.2079798. View

14.

Grimonprez A, Raedt R, Baeken C, Boon P, Vonck K . The antidepressant mechanism of action of vagus nerve stimulation: Evidence from preclinical studies. Neurosci Biobehav Rev. 2015; 56:26-34. DOI: 10.1016/j.neubiorev.2015.06.019. View

15.

Weber S . Use of Mixed Amphetamine Salts in a Patient with Depersonalization/Derealization Disorder. Innov Clin Neurosci. 2020; 17(1-3):45-48. PMC: 7239558. View

16.

Ballard C, MOHAN R, Handy S . Chronic depersonalisation neurosis au Shorvon--a successful intervention. Br J Psychiatry. 1992; 160:123-5. DOI: 10.1192/bjp.160.1.123. View

17.

Hamilton M . Development of a rating scale for primary depressive illness. Br J Soc Clin Psychol. 1967; 6(4):278-96. DOI: 10.1111/j.2044-8260.1967.tb00530.x. View

18.

Simeon D, Guralnik O, Hazlett E, Hollander E, Buchsbaum M . Feeling unreal: a PET study of depersonalization disorder. Am J Psychiatry. 2000; 157(11):1782-8. DOI: 10.1176/appi.ajp.157.11.1782. View

19.

Nuechterlein K, Green M, Kern R, Baade L, Barch D, Cohen J . The MATRICS Consensus Cognitive Battery, part 1: test selection, reliability, and validity. Am J Psychiatry. 2008; 165(2):203-13. DOI: 10.1176/appi.ajp.2007.07010042. View

20.

Shi C, Kang L, Yao S, Ma Y, Li T, Liang Y . The MATRICS Consensus Cognitive Battery (MCCB): Co-norming and standardization in China. Schizophr Res. 2015; 169(1-3):109-115. PMC: 4916953. DOI: 10.1016/j.schres.2015.09.003. View