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tDCS in Treatment of Craving in Sexual Addiction (CAS)

C

Centre Hospitalier St Anne

Status

Not yet enrolling

Conditions

Hypersexualism
Sexual Addiction

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04923451
D20-P039

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

Male

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

50 participants in 2 patient groups

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

Trial contacts and locations

0

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Central trial contact

Florence Thibaut, MD-PHD; Leo Malandain, MD

Data sourced from clinicaltrials.gov

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