tDCS in Treatment of Craving in Sexual Addiction (CAS)

June 9, 2021 updated by: Centre Hospitalier St Anne

Transcranial Electrical Stimulation in Sexual Addiction: an Innovative Treatment for a Better Understanding of the Physiopathology of Craving

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patient with sexual addiction - active stimulation
25 patients with sexual addiction will be stimulated by active tDCS during 5 consecutive days
Device: Active Trans-cranial direct current stimulation (tDCS)
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
Sham Comparator: Patient with sexual addiction - sham stimulation (placebo)
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)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of tDCS in treatment of craving of sexual addiction
Time Frame: 3 years

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
Time Frame: 3 years
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
Time Frame: 3 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain structures involved in sexual addiction
Time Frame: 3 years

The secondary objectives are the evaluation of the brain structures involved in sexual addiction, especially craving, and the study of the modifications of the circuits involved after the application of tDCS.

A modification of the BOLD signal in fMRI in the mesolimbic reward system as well as in the dorsolateral prefrontal cortex, orbitofrontal cortex and the amygdala in response to erotic images is expected after tDCS. 50 patients with sexual addiction will be compared with 25 healthy subjects for this objective
3 years
Evaluation of Impulsivity with The Barratt Impulsiveness Scale
Time Frame: 3 years
In addition, the evaluation of impulsivity and inhibition capacities of the frontal cortex will be conducted.Changes in impulsivity scale scores and motor inhibition task scores are expected after tDCS.
3 years
Evaluation of Impulsivity with UPPS-P Impulsive Behavior Scale
Time Frame: 3 years
A decrease in scores on this scale is expected after stimulation compared to patients who received placebo stimulation.
3 years
Evaluation Evaluation of Impulsivity with Stop Signal Task
Time Frame: 3 years
A decrease in scores on this scale is expected after stimulation, compared to patients who received placebo stimulation.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier St Anne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2021

Primary Completion (Anticipated)

November 1, 2023

Study Completion (Anticipated)

October 1, 2024

Study Registration Dates

First Submitted

March 22, 2021

First Submitted That Met QC Criteria

June 9, 2021

First Posted (Actual)

June 11, 2021

Study Record Updates

Last Update Posted (Actual)

June 11, 2021

Last Update Submitted That Met QC Criteria

June 9, 2021

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D20-P039

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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