The Effect of Repeated Prefrontal Cortex Stimulation on Antisocial and Aggressive Behavior

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT02674516
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 2
• Actual Duration (Months): 65
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

This study investigates the relationship between prefrontal cortex activity and antisocial and aggressive behavior, and risk factors for such behavior. In the double-blind, randomized controlled trial, participants will undergo three sessions of anodal transcranial direct current stimulation of the dorsolateral prefrontal cortex or sham stimulation and complete survey and laboratory measures assessing antisocial behavior and risk factors. Heart rate and skin conductance will also be measured.

Condition or Disease	Intervention/Treatment	Phase
Antisocial Behavior; Aggression	Device: Transcranial direct current stimulation; Device: Sham transcranial direct current stimulation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: The Effect of Repeated Transcranial Direct Current Stimulation of the Prefrontal Cortex on Antisocial and Aggressive Behavior
• Actual Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Jun 1, 2020
• Actual Study Completion Date: Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Anodal stimulation Participants in the active stimulation group will undergo 3 sessions of anodal bilateral transcranial direct stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC) on three consecutive days. tDCS will be delivered by a battery-driven, constant-current stimulator connected to three saline-soaked surface sponge electrodes. Two anodal electrodes (25cm2) will be placed over the DLPFC bilaterally and one cathodal electrode (35cm2) will be placed at the back of the neck. Scalp electrodes will be positioned over the F3 and F4 according to the 10-20 EEG international system. A current of 2mA (1mA at each DLPFC site) will be applied for 20 minutes and the current will be ramped up and down at the beginning and end of the stimulation period.	Device: Transcranial direct current stimulation
Sham Comparator: Sham stimulation The sham transcranial direct current stimulation condition will involve the same placement of the electrodes, current intensity, and ramp time as the real tDCS condition, but stimulation will only last for 30 seconds.	Device: Sham transcranial direct current stimulation

Outcome Measures

Primary Outcome Measures

1. Number of Pins Inserted Into a Virtual Voodoo Doll After 48 Hours [On average, 48 hours after the first 20-minute tDCS or sham session ends]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Above 18 years of age

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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania

Investigators

• Principal Investigator: Adrian Raine, DPhil, University of Pennsylvania

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 7, 2022

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT02674516
• Other Study ID Numbers: 823967
• First Posted: Feb 4, 2016
• Last Update Posted: Jan 18, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by University of Pennsylvania: antisocial behavior; aggression; transcranial direct current stimulation; dorsolateral prefrontal cortex; associated risk factors
• Additional relevant MeSH terms: Aggression; Antisocial Personality Disorder

Study Results

Participant Flow

Arm/Group Title	Anodal Stimulation	Sham Stimulation
Arm/Group Description	Participants in the active stimulation group will undergo 3 sessions of anodal bilateral transcranial direct stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC) on three consecutive days. tDCS will be delivered by a battery-driven, constant-current stimulator connected to three saline-soaked surface sponge electrodes. Two anodal electrodes (25cm2) will be placed over the DLPFC bilaterally and one cathodal electrode (35cm2) will be placed at the back of the neck. Scalp electrodes will be positioned over the F3 and F4 according to the 10-20 EEG international system. A current of 2mA (1mA at each DLPFC site) will be applied for 20 minutes and the current will be ramped up and down at the beginning and end of the stimulation period. Transcranial direct current stimulation	The sham transcranial direct current stimulation condition will involve the same placement of the electrodes, current intensity, and ramp time as the real tDCS condition, but stimulation will only last for 30 seconds. Sham transcranial direct current stimulation
Period Title: Overall Study
STARTED	17	15
COMPLETED	13	11
NOT COMPLETED	4	4

Baseline Characteristics

Arm/Group Title	Anodal Stimulation	Sham Stimulation	Total
Arm/Group Description	Participants in the active stimulation group will undergo 3 sessions of anodal bilateral transcranial direct stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC) on three consecutive days. tDCS will be delivered by a battery-driven, constant-current stimulator connected to three saline-soaked surface sponge electrodes. Two anodal electrodes (25cm2) will be placed over the DLPFC bilaterally and one cathodal electrode (35cm2) will be placed at the back of the neck. Scalp electrodes will be positioned over the F3 and F4 according to the 10-20 EEG international system. A current of 2mA (1mA at each DLPFC site) will be applied for 20 minutes and the current will be ramped up and down at the beginning and end of the stimulation period. Transcranial direct current stimulation	The sham transcranial direct current stimulation condition will involve the same placement of the electrodes, current intensity, and ramp time as the real tDCS condition, but stimulation will only last for 30 seconds. Sham transcranial direct current stimulation	Total of all reporting groups
Overall Participants	13	11	24
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.15 (10.77)	33.27 (14.10)	32.13 (12.17)
Sex: Female, Male (Count of Participants)
Female	7 53.8%	5 45.5%	12 50%
Male	6 46.2%	6 54.5%	12 50%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	3 23.1%	4 36.4%	7 29.2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	3 23.1%	3 27.3%	6 25%
White	6 46.2%	4 36.4%	10 41.7%
More than one race	1 7.7%	0 0%	1 4.2%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	13 100%	11 100%	24 100%

Outcome Measures

1. Primary Outcome

Title	Number of Pins Inserted Into a Virtual Voodoo Doll After 48 Hours
Description	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.
Time Frame	On average, 48 hours after the first 20-minute tDCS or sham session ends

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anodal Stimulation	Sham Stimulation
Arm/Group Description	Participants in the active stimulation group will undergo 3 sessions of anodal bilateral transcranial direct stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC) on three consecutive days. tDCS will be delivered by a battery-driven, constant-current stimulator connected to three saline-soaked surface sponge electrodes. Two anodal electrodes (25cm2) will be placed over the DLPFC bilaterally and one cathodal electrode (35cm2) will be placed at the back of the neck. Scalp electrodes will be positioned over the F3 and F4 according to the 10-20 EEG international system. A current of 2mA (1mA at each DLPFC site) will be applied for 20 minutes and the current will be ramped up and down at the beginning and end of the stimulation period. Transcranial direct current stimulation	The sham transcranial direct current stimulation condition will involve the same placement of the electrodes, current intensity, and ramp time as the real tDCS condition, but stimulation will only last for 30 seconds. Sham transcranial direct current stimulation
Measure Participants	13	11
Mean (Standard Deviation) [pins]	3.77 (8.88)	.64 (1.50)

Adverse Events

Time Frame	48 hours after the end of the first stimulation session
Arm/Group Title	Anodal Stimulation		Sham Stimulation
Arm/Group Description	Participants in the active stimulation group will undergo 3 sessions of anodal bilateral transcranial direct stimulation (tDCS) of the dorsolateral prefrontal cortex (DLPFC) on three consecutive days. tDCS will be delivered by a battery-driven, constant-current stimulator connected to three saline-soaked surface sponge electrodes. Two anodal electrodes (25cm2) will be placed over the DLPFC bilaterally and one cathodal electrode (35cm2) will be placed at the back of the neck. Scalp electrodes will be positioned over the F3 and F4 according to the 10-20 EEG international system. A current of 2mA (1mA at each DLPFC site) will be applied for 20 minutes and the current will be ramped up and down at the beginning and end of the stimulation period. Transcranial direct current stimulation		The sham transcranial direct current stimulation condition will involve the same placement of the electrodes, current intensity, and ramp time as the real tDCS condition, but stimulation will only last for 30 seconds. Sham transcranial direct current stimulation
All Cause Mortality
	Anodal Stimulation		Sham Stimulation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/11 (0%)
Serious Adverse Events
	Anodal Stimulation		Sham Stimulation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/11 (0%)
Other (Not Including Serious) Adverse Events
	Anodal Stimulation		Sham Stimulation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/13 (92.3%)		8/11 (72.7%)
General disorders
Lightheadedness	3/13 (23.1%)	3	1/11 (9.1%)	1
Iron taste	2/13 (15.4%)	2	1/11 (9.1%)	1
Fatigue	3/13 (23.1%)	3	1/11 (9.1%)	1
Skin and subcutaneous tissue disorders
Itchiness	12/13 (92.3%)	12	4/11 (36.4%)	4
Pain	6/13 (46.2%)	6	3/11 (27.3%)	3
Burning	9/13 (69.2%)	9	4/11 (36.4%)	4
Mild warmth	5/13 (38.5%)	5	1/11 (9.1%)	1
Pinching	6/13 (46.2%)	6	3/11 (27.3%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.