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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02427672
Other study ID # 821313
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2015
Est. completion date December 2018

Study information

Verified date August 2019
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study investigates the effect of upregulating prefrontal cortex activity on antisocial and aggressive behavior and risk factors for such behavior. In the double-blind, randomized controlled trial, participants will undergo anodal transcranial direct current stimulation bilaterally to the dorsolateral prefrontal cortex or a sham stimulation. During and after stimulation, they will complete survey and laboratory measures assessing antisocial and aggressive behavior and risk factors for antisocial and aggressive behavior. Heart rate and skin conductance will also be measured.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date December 2018
Est. primary completion date December 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Above 18 years of age

- Able to understand the nature of the study and give informed consent

Exclusion Criteria:

- History of or active neurologic, cardiovascular, or psychiatric disease

- Currently consuming anti-convulsant, anti-psychotic, or sedative/hypnotic medications

- Currently consuming anti-depressants

- History of seizures

- Metallic implants on the scalp

- Participation in other transcranial magnetic stimulation (TMS) or tDCS experiments on the same day

- History of adverse reactions to tDCS

Study Design


Intervention

Device:
Transcranial direct current stimulation

Sham transcranial direct current stimulation


Locations

Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (1)

Choy O, Raine A, Hamilton RH. Stimulation of the Prefrontal Cortex Reduces Intentions to Commit Aggression: A Randomized, Double-Blind, Placebo-Controlled, Stratified, Parallel-Group Trial. J Neurosci. 2018 Jul 18;38(29):6505-6512. doi: 10.1523/JNEUROSCI. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Antisocial Behavior Inclinations at 24 Hours This will be assessed using hypothetical scenarios in which someone commits a criminal or antisocial act. The two brief scenarios describe a physical assault and a sexual assault. Participants will respond to the likelihood that they would commit the act in the scenario according to a 10-point Likert scale. Responses were measured on a scale ranging from zero (no chance at all) to ten (100 percent chance). Scores for both scenarios were summed to obtain an overall measure of intentions to commit aggression. Possible scores range from 0 to 20. A higher value indicates a greater inclination to engage in the antisocial act. Baseline (an average of 15 minutes before receiving tDCS or sham) and on average, 24 hours following stimulation or sham
Primary Number of Pins Inserted Into a Virtual Voodoo Doll at 24 Hours The number of pins (between 0 and 51) that participants decide to insert into a picture of a voodoo doll on a computer that represents either a romantic partner or close friend will be recorded on average 24 hours after receiving tDCS or sham stimulation. On average, 24 hours after the tDCS or sham session
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