Transcranial Magnetic Stimulation for PTSD

Not yet recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Suicidal intent, Psychotic disorder, Bipolar, Neurological disorder, Cranial surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 2 days

What You Need to Know Before You Apply

What is the purpose of this trial?

PTSD is one of the most universal and severe psychiatric disorders whose incidence continues to rise due to the common exposure to severe trauma in the United States and worldwide. After trauma, a proportion of individuals maintains high symptoms of PTSD and depression, which can persist for years. The early weeks following trauma present a unique opportunity to deliver early interventions that can prevent chronic PTSD and depression from occurring, and the researchers propose a brain-based intervention that will reduce reactivity to threat, an early risk mechanism for chronic PTSD. This study is being done to learn more about whether brain stimulation in the weeks after a trauma can change brain activity that is linked to Post-Traumatic Stress Disorder (PTSD).

Who Is on the Research Team?

Sanne van Rooij, PhD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

Inclusion Criteria

I have been on the same dose of my psychiatric medication for at least 6 weeks.

I am between 18 and 65 years old.

Trauma exposed within the last 2 weeks

Exclusion Criteria

Having active suicidal intent or plan, or in the clinician's opinion, is likely to attempt suicide within the next six months

Lifetime diagnosis of psychotic disorder or bipolar disorder per psychiatric screener

History of cranial surgery, metallic particles in the eye or head (exclusive of mouth), implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, intra-cranial implants (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes), or implanted medical pumps

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Transcranial Magnetic Stimulation (TMS) sessions, including both active and sham components, to test its effect on brain activity linked to PTSD.

2 days

Multiple sessions over 2 days

Follow-up

Participants are monitored for changes in amygdala threat reactivity and overall brain activity post-TMS intervention.

2 days

Day 1 and Day 2 post-TMS intervention

Long-term Follow-up

Participants are monitored for long-term effects of TMS on PTSD symptoms and brain activity.

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Magnetic Stimulation (TMS)

How Is the Trial Designed?

Group I: Transcranial Magnetic Stimulation (TMS) Experimental Treatment 1 Intervention

All participants will complete two days that will contain both neuroimaging and TMS components and will take approximately 4 hours. Some TMS components will consist of active TMS, and other TMS components will consist of sham (placebo) TMS.

Group II: Control Application Placebo Group 1 Intervention

All participants will experience multiple single-blind sham control TMS sessions (30-minute sessions) and post-sham MRI scan.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+