Transcranial Direct Current Stimulation in Offenders

NCT ID: NCT03036683

Last Updated: 2022-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2022-06-01

Brief Summary

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This study investigates the effect of upregulating prefrontal cortex activity on risk-taking, and antisocial and aggressive behavior in violent offenders. In the double-blind, randomized controlled trial, using a within-subject crossover design, each participant will undergo anodal transcranial direct current stimulation of the right dorsolateral prefrontal cortex and sham stimulation. After each stimulation session, neural activity and behavioral responses to tasks assessing risk-taking and aggressive behavior will be recorded. The effect of tDCS on violent offenders will also be assessed in comparison to age and gender-matched healthy controls.

Detailed Description

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Conditions

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Aggression Risk-Taking Antisocial Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Anodal stimulation

Participants in the active stimulation group will undergo anodal transcranial direct current stimulation (tDCS). tDCS will be delivered by a battery-driven, constant-current stimulator connected to two saline-soaked surface sponge electrodes. An anodal electrode (25cm2) will be placed over the right dorsolateral prefrontal cortex and one cathodal electrode (100cm2) will be placed over the left supraorbital area at least 5cm from the anode. Scalp electrodes will be positioned according to the 10-20 EEG international system. A current of 2mA will be applied for 20 minutes and the current will be ramped up and down over 20 seconds at the beginning and end of the stimulation period.

Group Type EXPERIMENTAL

Transcranial direct current stimulation

Intervention Type DEVICE

Transcranial direct current stimulation will be administered for 20 minutes using a CE approved stimulator (NeuroConn, Ilmenau, Germany).

Sham stimulation

The sham tDCS condition will involve the same placement of the electrodes, current intensity, and ramp-up/down time as the active tDCS condition, but stimulation will only last for 30 seconds.

Group Type SHAM_COMPARATOR

Sham transcranial direct current stimulation

Intervention Type DEVICE

The same device will be used as in the active stimulation group, but stimulation will be terminated after 30 seconds.

Interventions

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Transcranial direct current stimulation

Transcranial direct current stimulation will be administered for 20 minutes using a CE approved stimulator (NeuroConn, Ilmenau, Germany).

Intervention Type DEVICE

Sham transcranial direct current stimulation

The same device will be used as in the active stimulation group, but stimulation will be terminated after 30 seconds.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Between 18 and 50 years of age
* Able to understand the nature of the study and give informed consent
* Individuals in the violent offender group must have a record of repeated violent criminal offending (at least 2 felonies).
* Individuals in the violent offender group must have been convicted solely due to crimes involving violence motivated by impulsive aggression.

Exclusion Criteria

* Presence of any contraindications for functional magnetic resonance imaging (fMRI)
* History of significant medical illness
* History of any neurological condition
* Diagnosis of schizophrenia
* History of epilepsy
* Head injury
* Mental retardation
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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RWTH Aachen University

OTHER

Sponsor Role collaborator

Olivia Choy

OTHER

Sponsor Role lead

Responsible Party

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Olivia Choy

PhD candidate

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ute Habel, PhD

Role: PRINCIPAL_INVESTIGATOR

RWTH Aachen University

Locations

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Uniklinik RWTH Aachen

Aachen, , Germany

Site Status

Countries

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Germany

References

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Klasen M, Zvyagintsev M, Schwenzer M, Mathiak KA, Sarkheil P, Weber R, Mathiak K. Quetiapine modulates functional connectivity in brain aggression networks. Neuroimage. 2013 Jul 15;75:20-26. doi: 10.1016/j.neuroimage.2013.02.053. Epub 2013 Mar 7.

Reference Type BACKGROUND
PMID: 23501053 (View on PubMed)

Other Identifiers

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EK 341/16

Identifier Type: -

Identifier Source: org_study_id

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