PedophiliatDCSNCT03825627
From Attention to Behavior: Increasing Behavioral Inhibition
A study testing Transcranial Direct Current Stimulation in people with Pedophilia, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pedophilia
- What is being tested?
- Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Anastasios Ziogas, M.Sc. contact
Switzerland1 site, 1 recruiting
- Recruiting
Psychiatrische Universitätsklinik Zürich
Zurich
Nathalie Brackmann, PhD
About this study
Official title: From Attention to Behavior: Increasing Behavioral Inhibition Through Transcranial Direct Current Stimulation in Pedophilia
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.
Read the 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.
- Conditions
- Pedophilia
- Being tested
- Transcranial Direct Current Stimulation
- Medical subject headings
- Pedophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start1 Jun 2019
- Primary completion1 Oct 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for PedophiliaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie Brackmann, Dr., Principal investigator, University Hospital of Psychiatry Zurich, Department of Forensic Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03825627
- Sponsor's protocol ID
- 2018-02028
- Other IDs
- 2018
- Acronym
- tDCS
- Status last verified
- Aug 2019
- First submitted
- 22 Jan 2019
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23296092Cacioppo 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.
PubMed 8355142Ettinger 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.
PubMed 17728263Fromberger 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.
PubMed 22548761Oberlader 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.
PubMed 27752855Phaf 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.
PubMed 24847292Poeppl 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.
PubMed 23399486Weidacker 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.
PubMed 29188755
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Attention to Behavior: Increasing Behavioral Inhibition Through Transcranial Direct Current Stimulation in Pedophilia
- ClinicalTrials.gov ID
- NCT03825627
- Acronym / sponsor ID
- tDCS / 2018-02028
- Conditions
- Pedophilia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 31 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Antisaccade Task (active tDCS) | Active comparator | Device: Transcranial Direct Current StimulationDuring 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. |
| Antisaccade Task (sham tDCS) | Sham comparator | Device: Transcranial Direct Current StimulationDuring 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. |
| Approach Avoidance Task (active tDCS) | Active comparator | Device: Transcranial Direct Current StimulationDuring 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. |
| Approach Avoidance Task (sham tDCS) | Sham comparator | Device: Transcranial Direct Current StimulationDuring 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients
- Diagnosed with pedophilia (further psychiatric illnesses possible)
- Sufficient German language skills
- Not diagnosed with Pedophilia (or other psychiatric illnesses)
- Sufficient German language skills
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current StimulationConductive 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). | Device | Antisaccade Task (active tDCS), Antisaccade Task (sham tDCS), Approach Avoidance Task (active tDCS), Approach Avoidance Task (sham tDCS) |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Background: PubMed 23296092Dombert 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.
- Background: PubMed 8355142Cacioppo 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.
- Background: PubMed 17728263Ettinger 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.
- Background: PubMed 22548761Fromberger 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.
- Background: PubMed 27752855Oberlader 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.
- Background: PubMed 24847292Phaf 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.
- Background: PubMed 23399486Poeppl 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.
- Background: PubMed 29188755Weidacker 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anastasios Ziogas, M.Sc. contact
Nathalie Brackmann, Dr. principal investigator
University Hospital of Psychiatry Zurich, Department of Forensic Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation in people with Pedophilia, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nathalie Brackmann, Dr. (+41 (0)52 304 93 01, nathalie.brackmann@puk.zh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03825627, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2019.