From Attention to Behavior: Increasing Behavioral Inhibition

NCT03825627 | Unknown DMC

• 1 other identifier: 2018-02028
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Pedophilia

Outcome Measures

Primary Outcomes (2)

• Entry Time

  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.

  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.

• differential AAT index (∆RT)

  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.

  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.

Study Arms (4)

Antisaccade Task (active tDCS)

ACTIVE COMPARATOR

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

Antisaccade Task (sham tDCS)

SHAM COMPARATOR

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

Approach Avoidance Task (active tDCS)

ACTIVE COMPARATOR

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

Approach Avoidance Task (sham tDCS)

SHAM COMPARATOR

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

Interventions

Transcranial Direct Current Stimulation DEVICE

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).

Antisaccade Task (active tDCS); Antisaccade Task (sham tDCS); Approach Avoidance Task (active tDCS); Approach Avoidance Task (sham tDCS)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Psychiatrische Universitätsklinik Zürich

Zurich, Switzerland

RECRUITING

Related Publications (8)

• Dombert B, Mokros A, Bruckner E, Schlegl V, Antfolk J, Backstrom A, Zappala A, Osterheider M, Santtila P. The virtual people set: developing computer-generated stimuli for the assessment of pedophilic sexual interest. Sex Abuse. 2013 Dec;25(6):557-82. doi: 10.1177/1079063212469062. Epub 2013 Jan 7.

  PMID: 23296092 BACKGROUND

• Cacioppo JT, Priester JR, Berntson GG. Rudimentary determinants of attitudes. II: Arm flexion and extension have differential effects on attitudes. J Pers Soc Psychol. 1993 Jul;65(1):5-17. doi: 10.1037//0022-3514.65.1.5.

  PMID: 8355142 BACKGROUND

• Ettinger U, Ffytche DH, Kumari V, Kathmann N, Reuter B, Zelaya F, Williams SC. Decomposing the neural correlates of antisaccade eye movements using event-related FMRI. Cereb Cortex. 2008 May;18(5):1148-59. doi: 10.1093/cercor/bhm147. Epub 2007 Aug 28.

  PMID: 17728263 BACKGROUND

• Fromberger P, Jordan K, Steinkrauss H, von Herder J, Witzel J, Stolpmann G, Kroner-Herwig B, Muller JL. Diagnostic accuracy of eye movements in assessing pedophilia. J Sex Med. 2012 Jul;9(7):1868-82. doi: 10.1111/j.1743-6109.2012.02754.x. Epub 2012 Apr 30.

  PMID: 22548761 BACKGROUND

• Oberlader VA, Ettinger U, Banse R, Schmidt AF. Development of a Cued Pro- and Antisaccade Paradigm: An Indirect Measure to Explore Automatic Components of Sexual Interest. Arch Sex Behav. 2017 Nov;46(8):2377-2388. doi: 10.1007/s10508-016-0839-7. Epub 2016 Oct 17.

  PMID: 27752855 BACKGROUND

• Phaf RH, Mohr SE, Rotteveel M, Wicherts JM. Approach, avoidance, and affect: a meta-analysis of approach-avoidance tendencies in manual reaction time tasks. Front Psychol. 2014 May 8;5:378. doi: 10.3389/fpsyg.2014.00378. eCollection 2014.

  PMID: 24847292 BACKGROUND

• Poeppl TB, Nitschke J, Santtila P, Schecklmann M, Langguth B, Greenlee MW, Osterheider M, Mokros A. Association between brain structure and phenotypic characteristics in pedophilia. J Psychiatr Res. 2013 May;47(5):678-85. doi: 10.1016/j.jpsychires.2013.01.003. Epub 2013 Feb 9.

  PMID: 23399486 BACKGROUND

• Weidacker K, Kargel C, Massau C, Weiss S, Kneer J, Krueger THC, Schiffer B. Approach and Avoidance Tendencies Toward Picture Stimuli of (Pre-)Pubescent Children and Adults: An Investigation in Pedophilic and Nonpedophilic Samples. Sex Abuse. 2018 Oct;30(7):781-802. doi: 10.1177/1079063217697134. Epub 2017 Mar 20.

  PMID: 29188755 BACKGROUND

MeSH Terms

Conditions

Pedophilia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Paraphilic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Nathalie Brackmann, Dr.

  University Hospital of Psychiatry Zurich, Department of Forensic Psychiatry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie Brackmann, Dr.

CONTACT

+41 (0)52 304 93 01; nathalie.brackmann@puk.zh.ch

Anastasios Ziogas, M.Sc.

CONTACT

anastasios.ziogas@puk.zh.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: January 31, 2019
• Study Start: June 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: December 31, 2020
• Last Updated: August 13, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)