60 Participants NeededMy employer runs this trial

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 trial explores whether transcranial magnetic stimulation (TMS), which uses magnetic fields to stimulate brain areas, can enhance social thinking and brain function in adults with high levels of psychopathic traits. Participants will receive either the real TMS treatment—specifically continuous theta burst stimulation (cTBS) or intermittent theta burst stimulation (iTBS)—or a placebo version, and their results will be compared. Suitable candidates for this trial exhibit traits associated with psychopathy and have no major mental health conditions like schizophrenia or bipolar disorder.

As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research in understanding and potentially improving social cognition.

Do I have to stop taking my current medications for the trial?

Yes, you must not change your psychiatric medication regimen for 4 weeks before the study, or you must be medication-free.

What prior data suggests that transcranial magnetic stimulation is safe for adults with elevated psychopathic traits?

Research has shown that both continuous theta burst stimulation (cTBS) and intermittent theta burst stimulation (iTBS) are generally safe. Studies have found cTBS to be well-tolerated, with no major safety concerns, and it is considered safe for various groups, including those with mental health issues, without significant side effects.

For iTBS, research has identified it as a safe and practical treatment. It has been used in individuals with depression and personality disorders without major problems. Participants receiving iTBS have not reported serious side effects, making it a promising option for brain stimulation treatments.

Overall, both cTBS and iTBS have demonstrated a good safety record in research, with few adverse events.12345

Why are researchers excited about this trial?

Researchers are excited about using transcranial magnetic stimulation (TMS) for Antisocial Personality Disorder (ASPD) because it offers a non-invasive approach that targets brain regions involved in behavior control. Unlike current treatments like psychotherapy or medications that often take weeks or months to show effects, TMS can potentially produce quicker results by directly stimulating brain activity. Specifically, continuous theta burst stimulation (cTBS) and intermittent theta burst stimulation (iTBS) are being explored to see their effectiveness in modulating areas of the brain such as the dorsolateral prefrontal cortex (dlPFC) and the temporoparietal junction (TPJ), which are believed to play crucial roles in impulse control and empathy. This offers a novel mechanism of action that could pave the way for new treatment avenues in managing ASPD.

What evidence suggests that this trial's treatments could be effective for antisocial personality disorder?

Research has shown that transcranial magnetic stimulation (TMS) can enhance brain function. Specifically, two types of TMS, continuous theta burst stimulation (cTBS) and intermittent theta burst stimulation (iTBS), have demonstrated positive results. In this trial, participants will receive either active cTBS to the dlPFC with sham to the TPJ, active iTBS to the TPJ with sham to the dlPFC, or sham stimulation to both areas. Studies have found that cTBS is safe and effective for treating major depressive disorder, and it can also enhance cognitive skills and brain connectivity. Similarly, iTBS has improved cognitive function and reduced negative symptoms in individuals with schizophrenia. Evidence also indicates that iTBS can reduce cravings in those with substance use disorders. These findings suggest that TMS might enhance cognitive and social understanding in individuals with high levels of psychopathic traits.678910

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+

Citations

Effectiveness of accelerated intermittent theta burst ...

The results suggest that accelerated iTBS may be a safe and effective neuromodulation technique to improve the overall functional recovery of individuals ...

Theta Burst Stimulation for Depression and Autism · Info ...

Continuous theta burst stimulation (cTBS) was found to be safe and well-tolerated in patients with major depressive disorder (MDD) or bipolar depression (BD),

The Effect of Intermittent Theta Burst Stimulation (iTBS) in ...

The primary outcome of the study will be decrease of visual analogue scale (VAS) scores from baseline to the end of treatment.

(PDF) Efficacy of Using Intermittent Theta Burst Stimulation ...

Recent trials have shown preliminary evidence for the efficacy of using intermittent theta burst stimulation (iTBS) in treating negative ...

Theta-Burst Stimulation as a Treatment for... | Clinical Trial

Objective: The goal of this clinical trial is to assess the tolerability of an accelerated intermittent theta burst stimulation (iTBS), ...

Theta-Enforcing Neuroplasticity Therapy (TENT) ...

Addendum D to the proposed TENT treatment (draft): (See concept paper: Theta-Enforcing Neuroplasticity Therapy (TENT) for Malignant Narcissism and Antisocial ...

BMJ Open is committed to open peer review. As ...

brain stimulation techniques and mental disorders. The findings will help improve safety. 43 ... Safety of Theta Burst Transcranial Magnetic Stimulation: A ... data ...

(PDF) Non-Invasive Brain Stimulation for the Modulation of ...

... antisocial intention assessment. The results showed no. significant group differences in aggressive behavior measured using the VDT or ...

NCT02573246 10/20/2019 Enhancing Cognitive Restructuring ...

Objects and Significance. This study was based on the overall hypothesis that an integrating high frequency (HF). rTMS with an evidence based ...

Investigating the neural foundations of retribution and forgiveness

Theta burst stimulation of the prefrontal cortex: safety ... To sum up the behavioral data, following inhibitory stimulation of the right DLPFC, participants.