Clinical trial NCT04923451: tDCS in Treatment of Craving in Sexual Addiction
Official title: Transcranial Electrical Stimulation in Sexual Addiction: an Innovative Treatment for a Better Understanding of the Physiopathology of Craving
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sexual Addiction
Hypersexualism
Keywords: Sexual Addiction
Hypersexualism
Neurostimulation
tDCS
fMRI
Lead sponsor: Centre Hospitalier St Anne
Sponsor class: OTHER
First posted: 2021-06-11
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Quantitative data regarding the intensity of emotional response and craving to erotic images, motor inhibition task and impulsivity will be presented in the form of frequency, mean and standard deviation (SD) calculations and compared using a 2-factor repeated measures ANOVA taking into account the fact that the patient will be compared to himself (position 1 and 2 and placebo) and to other patients using 3 kinds of images (erotic, social and neutral) with 3 types of possible stimulations.

In order to analyze the fMRI data, the regions of the patient's body will be identified. in which the BOLD activity will be correlated to the attractiveness of the image. Foreach patient, the difference before and after stimulation will be calculated. There will be no intermediate analysis.
Primary purpose: TREATMENT

Brief summary: In patients with addiction to a substance, an increase in activity in the prefrontal cortex induced by transcranial Direct Current Stimulation -tDCS (non-invasive technique, modulating cortical activity by applying low-intensity electrical currents between two electrodes),may help reduce craving in people addicted to alcohol and tobacco. By analogy with addictive behavior with a substance, the craving observed in certain behavioral addictions would involve the same neural circuits.

The main hypothesis is to reduce the sexual craving associated with the viewing of erotic images during active brain stimulation compared to placebo stimulation. Functional MRI will allow to better understand the neural circuits involved in sexual addiction and in the expected inhibition of sexual arousal by tDCS in sexual addictions during visualization erotic images.

Detailed description: The concept of sexual addiction appeared in American literature about 20 years ago. The term sexual addiction describes an excessive, increasing, and especially uncontrolled frequency of sexual behavior, as a conventional rule, associated with a compelling and irrepressible sexual desire (craving), which persists in spite of the possible negative consequences and personal suffering of the subject. The prevalence of this condition is estimated to be approximately 3-6% in the general population in the United States, it is independent of the socio-cultural environment. The pathophysiology of sexual addictions remains very poorly understood.

Numerous studies have focused on substance addictions and their pathophysiology. The mesolimbic dopaminergic system plays a major role in addictive behavior. The prefrontal cortex and the basolateral region of the amygdala play an important role in the craving and may cause relapse in subjects. In subjects with sexual addiction, only one controlled study has been conducted on the role of antidepressant treatment in the reduction of craving. The objective of the study is not only to evaluate the efficacy of tDCS neurostimulation in this disorder but also to identify the brain structures involved in this addictive disorder.

Eligibility criteria: Inclusion Criteria:

* 18-60 year old male
* Heterosexual
* Right-handed (Manual laterality test)
* With a sexual addiction (PEACCE Tool\> 3 and Carnes ≥ 13/25) except for controls
* Having signed a written and informed consent
* Subject benefiting from social security

Exclusion Criteria:

* Subject presenting a medical pathology requiring drug treatment,
* Severe psychiatric pathology (bipolar disorder, hyperactivity or schizophrenia) or another addiction (alcohol, illicit substances or behavioral addiction)
* Subject consuming psychotropic drugs in progress or during the last month
* Subject not understanding French
* Subject under tutorship or curatorship
* Subjects with neurological disease including epilepsy or a history of head trauma
* Subjects hospitalized in enforced hospitalization
* Subject presenting a contraindication to tDCS: subject with an electrical or metal brain implant
* Subject with a contraindication to MRI

Primary outcomes:
measure: Efficacy of tDCS in treatment of craving of sexual addiction
timeFrame: 3 years
measure: Efficacy of tDCS in treatment of sexual addiction in subjective emotional response
timeFrame: 3 years
measure: Efficacy of tDCS in treatment of sexual addiction in objective emotional response
timeFrame: 3 years
Secondary outcomes:
measure: Brain structures involved in sexual addiction
timeFrame: 3 years
measure: Evaluation of Impulsivity with The Barratt Impulsiveness Scale
timeFrame: 3 years
measure: Evaluation of Impulsivity with UPPS-P Impulsive Behavior Scale
timeFrame: 3 years
measure: Evaluation Evaluation of Impulsivity with Stop Signal Task
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
References:
citation: Garcia FD, Thibaut F. Sexual addictions. Am J Drug Alcohol Abuse. 2010 Sep;36(5):254-60. doi: 10.3109/00952990.2010.503823.
citation: Malandain L, Blanc JV, Ferreri F, Thibaut F. Pharmacotherapy of Sexual Addiction. Curr Psychiatry Rep. 2020 May 7;22(6):30. doi: 10.1007/s11920-020-01153-4.
citation: Wainberg ML, Muench F, Morgenstern J, Hollander E, Irwin TW, Parsons JT, Allen A, O'Leary A. A double-blind study of citalopram versus placebo in the treatment of compulsive sexual behaviors in gay and bisexual men. J Clin Psychiatry. 2006 Dec;67(12):1968-73. doi: 10.4088/jcp.v67n1218.
citation: Volkow ND, Wang GJ, Fowler JS, Tomasi D, Telang F. Addiction: beyond dopamine reward circuitry. Proc Natl Acad Sci U S A. 2011 Sep 13;108(37):15037-42. doi: 10.1073/pnas.1010654108. Epub 2011 Mar 14.
citation: Voon V, Mole TB, Banca P, Porter L, Morris L, Mitchell S, Lapa TR, Karr J, Harrison NA, Potenza MN, Irvine M. Neural correlates of sexual cue reactivity in individuals with and without compulsive sexual behaviours. PLoS One. 2014 Jul 11;9(7):e102419. doi: 10.1371/journal.pone.0102419. eCollection 2014.
citation: Rosenberg KP, Carnes P, O'Connor S. Evaluation and treatment of sex addiction. J Sex Marital Ther. 2014;40(2):77-91. doi: 10.1080/0092623X.2012.701268. Epub 2013 Jun 21.