tDCS in Treatment of Craving in Sexual Addiction

NCT04923451 | Unknown DMC

• 1 other identifier: D20-P039
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sexual Addiction; Hypersexualism

Keywords

Sexual Addiction; Hypersexualism; Neurostimulation; tDCS; fMRI

Outcome Measures

Primary Outcomes (3)

• Efficacy of tDCS in treatment of craving of sexual addiction

  The primary outcome is to assess the effectiveness of tDCS treatment on the reduction of the craving by comparing before and after active tDCS stimulation in response to erotic-pornographic images. Efficacy will be quantified by a sexual craving scale associated with erotico-pornographic images before and after tDCS stimulation. A significant decrease in craving and score on the scale is expected after tDCS stimulation. compared to control subjects. Images of social and neutral interactions will be used as comparison of expected changes. The scale used is the PATHOS scale: brief sexual addiction screening questionnaire.

  3 years

• Efficacy of tDCS in treatment of sexual addiction in subjective emotional response

  For the evaluation of efficacy of tDCS in emotional response, indirect measurement of craving, visual emotional responses scales (Likert) will be used during visualization of erotico-pornographic images, before and after stimulation. The "desire" will be quantified on a Likert scale from 0 to 7.

  3 years

• Efficacy of tDCS in treatment of sexual addiction in objective emotional response

  An assessment of emotional responses will also be done using heart rate measure during visualization of images in fMRI, before and after stimulation by tDCS

  3 years

Secondary Outcomes (4)

• Brain structures involved in sexual addiction

  3 years

• Evaluation of Impulsivity with The Barratt Impulsiveness Scale

  3 years

• Evaluation of Impulsivity with UPPS-P Impulsive Behavior Scale

  3 years

• Evaluation Evaluation of Impulsivity with Stop Signal Task

  3 years

Study Arms (2)

Patient with sexual addiction - active stimulation

ACTIVE COMPARATOR

25 patients with sexual addiction will be stimulated by active tDCS during 5 consecutive days

Device: Active Trans-cranial direct current stimulation (tDCS)

Patient with sexual addiction - sham stimulation (placebo)

SHAM COMPARATOR

25 patients with sexual addiction will be stimulated by sham tDCS stimulation (placebo) during 5 consecutive days

Device: Sham Trans-cranial direct current stimulation (tDCS)

Interventions

Active Trans-cranial direct current stimulation (tDCS) DEVICE

5 active sessions (1/day for 5 consecutive days) of tDCS (NeuroConn DC), active anode 8cm2 on right dorso-lateral prefrontal cortex and neutral cathode, 2 mA, during 30 min will be performed

Patient with sexual addiction - active stimulation

Sham Trans-cranial direct current stimulation (tDCS) DEVICE

5 placebo sessions (1/day for 5 consecutive days) of sham tDCS (NeuroConn DC), anode 8cm2 on right dorso-lateral prefrontal cortex and neutral cathode during 30min will be performed

Patient with sexual addiction - sham stimulation (placebo)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead

Related Publications (6)

• Garcia FD, Thibaut F. Sexual addictions. Am J Drug Alcohol Abuse. 2010 Sep;36(5):254-60. doi: 10.3109/00952990.2010.503823.

  PMID: 20666699 BACKGROUND

• 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.

  PMID: 32377953 BACKGROUND

• 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.

  PMID: 17194276 BACKGROUND

• 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.

  PMID: 21402948 BACKGROUND

• 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.

  PMID: 25013940 BACKGROUND

• 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.

  PMID: 23790248 BACKGROUND

MeSH Terms

Conditions

Compulsive Sexual Behavior Disorder

Condition Hierarchy (Ancestors)

Behavior, Addictive; Compulsive Behavior; Impulsive Behavior; Behavior; Sexual and Gender Disorders; Sexual Dysfunctions, Psychological; Mental Disorders

Central Study Contacts

Leo Malandain, MD

CONTACT

0033158411678; leo.malandain@aphp.fr

Florence Thibaut, MD-PHD

CONTACT

florence.thibaut@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Depending on the randomized group, the subject will receive one of two treatments 15 days apart (A: active anode on the right DLPFC and neutral cathode on the left shoulder; B: inactive anode on the DLPFC and inactive cathode on the left shoulder). The groups are defined as follows: The results of randomization will not be known by the evaluator.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: June 11, 2021
• Study Start: July 1, 2021
• Primary Completion: November 1, 2023
• Study Completion: October 1, 2024
• Last Updated: June 11, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share