Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

From Attention to Behavior: Increasing Behavioral Inhibition (tDCS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03825627
Recruitment Status : Recruiting
First Posted : January 31, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
This project will investigate if transcranial direct current stimulation can be used as treatment for Pedophilia. Treatment efficacy will be evaluated with behavioral tasks and the recording of eye-movement.

Condition or disease Intervention/treatment Phase
Pedophilia Device: Transcranial Direct Current Stimulation Not Applicable

Detailed Description:

Pedophilia is an important motivation for sexual offenses involving children, including child pornography and sexual contacts with children (henceforth, pedosexual behavior). Indeed, approximately half of individuals convicted for sexual offenses against children have a Pedophilic disorder and offenders with a Pedophilic disorder are much more likely to sexually reoffend.

A promising line of research has examined the neurocognitive basis of pedophilia. Pedophilic individuals display altered activity in the dorsolateral prefrontal cortex (dlPFC) when attending to child-related stimuli. This brain area is involved in the cognitive control of sexual arousal. Transcranial Direct Current Stimulation (tDCS) has been examined as a non-invasive method to increase activity in the dlPCF, ultimately increasing inhibitory control over impulses. Accumulating evidence also shows that individuals have an attentional bias towards sexually preferred stimuli. These attentional processes can be investigated by recording eye movements. Early automatic eye movements are particularly relevant in discriminating individuals with pedophilia from those without pedophilia.

The proposed study will examine the effects of tDCS over the dlPFC of pedophilic individuals and healthy controls, while they complete a task requiring controlled attention to virtual (computer-generated) images of children and adults. In two separate sessions, participants will be randomly assigned to an active and a placebo (sham) tDCS condition. Eye movements will be recorded during the task.

The investigators expect to observe a conflict between automatic and controlled attention when participants are presented with their sexually preferred stimuli. Specifically, the investigators expect pedophiles to show an attentional bias towards virtual child stimuli. The investigators predict that the attentional conflict will be reduced when tDCS is applied, compared to the sham condition. If the attentional bias is a key cognitive feature of sexual interest, the investigators expect to measure changes in reported or indirectly assessed sexual preferences.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: From Attention to Behavior: Increasing Behavioral Inhibition Through Transcranial Direct Current Stimulation in Pedophilia
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Active Comparator: Antisaccade Task (active tDCS)
During the antisaccade task, the investigators will show participants computer-generated images depicting clothed and sexually relevant (nude) children, young adults and adults of both genders. Images will be drawn from the Virtual People Set and the Not-Real-People Set (Pacific Psychological Assessment Corporation, 2004). Pedophilic participants are expected to show a sexual preference towards a prepubescent body scheme whereas stimuli displaying adolescence and adulthood (sexual maturity) are expected to be sexually preferred by the teleiophilic control participants. In this arm active Transcranial Direct Current Stimulation will be used to influence performance.
Device: Transcranial Direct Current Stimulation

Conductive saline-soaked rubber electrodes super-imposed on sponge plates will be placed on the scalp at F3 (active electrode, 4.4×4.4cm) and on the contralateral supraorbital area (reference electrode, 5.1×10.2cm).

Stimulation will be applied using a battery-driven constant-current regulator (Oasis Pro, Edmonton, Alberta, Canada). For each stimulation, the direct current is initially increased in a ramp-like fashion over 10 s until reaching 2 milliampere (mA) and will be similarly decreased at the end of stimulation.

In the active tDCS condition, stimulation will be maintained for 20 min; in the sham condition, it will be turned off after 15 s of stimulation, with a ramp-up/down of 10 s (i.e., 35 s total).


Sham Comparator: Antisaccade Task (sham tDCS)
During the antisaccade task, the investigators will show participants computer-generated images depicting clothed and sexually relevant (nude) children, young adults and adults of both genders. Images will be drawn from the Virtual People Set and the Not-Real-People Set (Pacific Psychological Assessment Corporation, 2004). Pedophilic participants are expected to show a sexual preference towards a prepubescent body scheme whereas stimuli displaying adolescence and adulthood (sexual maturity) are expected to be sexually preferred by the teleiophilic control participants. In this arm sham Transcranial Direct Current Stimulation will be used during the task.
Device: Transcranial Direct Current Stimulation

Conductive saline-soaked rubber electrodes super-imposed on sponge plates will be placed on the scalp at F3 (active electrode, 4.4×4.4cm) and on the contralateral supraorbital area (reference electrode, 5.1×10.2cm).

Stimulation will be applied using a battery-driven constant-current regulator (Oasis Pro, Edmonton, Alberta, Canada). For each stimulation, the direct current is initially increased in a ramp-like fashion over 10 s until reaching 2 milliampere (mA) and will be similarly decreased at the end of stimulation.

In the active tDCS condition, stimulation will be maintained for 20 min; in the sham condition, it will be turned off after 15 s of stimulation, with a ramp-up/down of 10 s (i.e., 35 s total).


Active Comparator: Approach Avoidance Task (active tDCS)
During the Approach-Avoidance Task (AAT), participants will look at a series of images depicting children and adults wearing swimsuits. The images were sampled from internet advertisements and do not constitute legally objectionable material. When sourcing the images, rigorous attention was paid to meet the criteria for fair use indicated by the American Psychological Association. There are 160 images in total. Half of the images will be used in the active and the other half in the sham condition (i.e., 20 female adults, 20 female children, 20 male adults, and 20 male children per condition). In this arm active Transcranial Direct Current Stimulation will be used to influence performance.
Device: Transcranial Direct Current Stimulation

Conductive saline-soaked rubber electrodes super-imposed on sponge plates will be placed on the scalp at F3 (active electrode, 4.4×4.4cm) and on the contralateral supraorbital area (reference electrode, 5.1×10.2cm).

Stimulation will be applied using a battery-driven constant-current regulator (Oasis Pro, Edmonton, Alberta, Canada). For each stimulation, the direct current is initially increased in a ramp-like fashion over 10 s until reaching 2 milliampere (mA) and will be similarly decreased at the end of stimulation.

In the active tDCS condition, stimulation will be maintained for 20 min; in the sham condition, it will be turned off after 15 s of stimulation, with a ramp-up/down of 10 s (i.e., 35 s total).


Sham Comparator: Approach Avoidance Task (sham tDCS)
During the Approach-Avoidance Task (AAT), participants will look at a series of images depicting children and adults wearing swimsuits. The images were sampled from internet advertisements and do not constitute legally objectionable material. When sourcing the images, rigorous attention was paid to meet the criteria for fair use indicated by the American Psychological Association. There are 160 images in total. Half of the images will be used in the active and the other half in the sham condition (i.e., 20 female adults, 20 female children, 20 male adults, and 20 male children per condition). In this arm sham Transcranial Direct Current Stimulation will be used during the task.
Device: Transcranial Direct Current Stimulation

Conductive saline-soaked rubber electrodes super-imposed on sponge plates will be placed on the scalp at F3 (active electrode, 4.4×4.4cm) and on the contralateral supraorbital area (reference electrode, 5.1×10.2cm).

Stimulation will be applied using a battery-driven constant-current regulator (Oasis Pro, Edmonton, Alberta, Canada). For each stimulation, the direct current is initially increased in a ramp-like fashion over 10 s until reaching 2 milliampere (mA) and will be similarly decreased at the end of stimulation.

In the active tDCS condition, stimulation will be maintained for 20 min; in the sham condition, it will be turned off after 15 s of stimulation, with a ramp-up/down of 10 s (i.e., 35 s total).





Primary Outcome Measures :
  1. Entry Time [ Time Frame: Through study completion, an average of 10 months. The outcome measure is not an event but a performance measure recorded for every participant in every session. ]
    In the Antisaccade task entry time will be recorded with an eye-tracker in both active and sham tDCS conditions. Time to first fixation (entry time) is defined as the time from stimulus onset to the first fixation directed to the target stimulus. This index can be treated as reaction time (RT) and will provide a measure of controlled attention. The location of the first fixation indicates which stimulus captures subject's automatic attention. The proportion of correct/incorrect fixations (%) will inform us about automatic attentional processes. Thus entry time is a single performance index measured with a unit of time, in this case Milliseconds (ms). Every participant's performance in the Antisaccade task will be measured with entry time (ms) as well as the percentage (%) of correct responses. Since the task is not difficult, the percentage values only serve to check for compliance with task instructions. The real focus of the study lies in the RT as recorded with entry time in ms.

  2. differential AAT index (∆RT) [ Time Frame: Through study completion, an average of 10 months. The outcome measure is not an event but a performance measure recorded for every participant in every session. ]
    In the Approach-Avoidance Task (AAT) the differential AAT index (∆RT) will be recorded in both active and sham tDCS condition using the response on the joystick. The proportion of correct/incorrect responses (%) will inform us about automatic attentional processes. Thus the ∆RT is a single performance index for speed tests measured with a unit of time, in this case Milliseconds (ms). It gives information on how fast participants responded using the joystick. In addition, the percentage (%) of correct responses with the joystick will be recorded. Since the task is not difficult, the percentage values only serve to check for compliance and if task instructions were understood. The real focus of the study lies in the RT as recorded with ∆RT in ms.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Patients

  • Diagnosed with pedophilia (further psychiatric illnesses possible)
  • Sufficient German language skills

Controls:

  • Not diagnosed with Pedophilia (or other psychiatric illnesses)
  • Sufficient German language skills

Exclusion Criteria:

Patients

  • Prior head injury with loss of consciousness for at least 5 min
  • Neurological diagnosis (including epilepsy) or prior medical conditions with possible central nervous system sequelae
  • Metallic implants inside the brain or any electrical medical device (e.g. pacemaker) in the body
  • Visual or hearing impairment, to the extent that it interferes with task instructions

Current medication in patients (antiandrogenic medication among the pedophilic subjects, in particular) will be recorded and acknowledged as a covariate.

Controls

  • Prior head injury with loss of consciousness for at least 5 min
  • Neurological diagnosis (including epilepsy) or prior medical conditions with possible central nervous system sequelae
  • Metallic implants inside the brain or any electrical medical device (e.g. pacemaker) in the body
  • Visual or hearing impairment, to the extent that it interferes with task instructions
  • Current or previous pedophilic sexual interest

For both groups further exclusion (prematurely) will occur if initial data shows that participants don't comply with instructions or if questionnaires hint toward a lack of sexual interest in general.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03825627


Contacts
Layout table for location contacts
Contact: Nathalie Brackmann, Dr. +41 (0)52 304 93 01 nathalie.brackmann@puk.zh.ch
Contact: Anastasios Ziogas, M.Sc. anastasios.ziogas@puk.zh.ch

Locations
Layout table for location information
Switzerland
Psychiatrische Universitätsklinik Zürich Recruiting
Zürich, Switzerland
Contact: Nathalie Brackmann, PhD         
Sponsors and Collaborators
University of Zurich
Investigators
Layout table for investigator information
Principal Investigator: Nathalie Brackmann, Dr. University Hospital of Psychiatry Zurich, Department of Forensic Psychiatry
Publications:

Layout table for additonal information
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03825627    
Other Study ID Numbers: 2018-02028
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pedophilia
Paraphilic Disorders
Mental Disorders