Transcranial Magnetic Stimulation for Antisocial Personality Disorder

DE
Overseen ByDrew E Winters, PhD.
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Colorado, Denver
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This clinical trial will examine whether transcranial magnetic stimulation (TMS), a noninvasive form of brain stimulation, can influence social cognition, cognitive processing, and brain function in adults with elevated psychopathic traits. The study will also evaluate the safety and feasibility of delivering TMS in this population.

Participants will be randomly assigned to receive either active TMS or sham (placebo-like) TMS. The study will compare outcomes between participants receiving active versus sham TMS and will evaluate changes from before to after TMS exposure.

Participants will:

* Complete a baseline magnetic resonance imaging (MRI) brain scan.

* Receive three single-session TMS interventions.

* Complete a post-intervention MRI brain scan.

* Complete assessments of social cognition.

* Complete assessments of cognitive processing.

The primary objectives are to determine whether TMS can influence social cognition, cognitive processing, and functional brain organization and connectivity in adults with elevated psychopathic traits.

Are You a Good Fit for This Trial?

This trial is for adults with high levels of psychopathic traits or antisocial personality disorder. Participants should be able to safely undergo MRI scans and TMS, and must not have conditions that would make these procedures unsafe.

Inclusion Criteria

Adequate English proficiency to complete study procedures and assessments
I am between 18 and 60 years old.
Elevated psychopathy as defined by the self-report psychopathy scale
See 6 more

Exclusion Criteria

Clinically significant abnormality identified on baseline MRI
Contraindication to MRI or inability to undergo MRI scanning
Diagnosis of dementia
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete a baseline MRI brain scan and assessments of social cognition and cognitive processing

1 week
1 visit (in-person)

Treatment

Participants receive three single-session TMS interventions, either active or sham

1 week
3 visits (in-person)

Post-intervention Assessment

Participants complete a post-intervention MRI brain scan and assessments of social cognition and cognitive processing

1 week
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • continuous theta burst stimulation (cTBS)
  • Intermittent theta burst stimulation (iTBS)

Trial Overview

The study tests whether transcranial magnetic stimulation (TMS)—using two types called cTBS and iTBS—can affect thinking skills, social understanding, and brain function compared to a sham (inactive) treatment. Participants are randomly assigned to one of the groups.

How Is the Trial Designed?

3

Treatment groups

Active Control

Placebo Group

Group I: active dlPFC sham TPJActive Control1 Intervention
Group II: active TPJ sham dlPFCActive Control1 Intervention
Group III: shamPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+