← Back to Search

Behavioural Intervention

Accelerated TMS for PTSD

N/A

Recruiting

Led By Frank A Kozel, MD

Research Sponsored by Florida State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults age 18 years to 65 years old

Be older than 18 years old

Must not have

We will exclude non-English speakers because of the need for rapid communication during the delivery of treatments

Medical contraindication for neuromodulation (e.g., ferrous metal in head, seizure disorder, brain tumor, stroke, aneurysm, multiple sclerosis, etc.)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessment of symptoms during the preceding week.

Summary

This trial will test a new treatment called accelerated TMS for PTSD that aims to quickly improve symptoms in just one week with 25 sessions over 5 days.

Who is the study for?

This trial is for individuals with PTSD or Traumatic Brain Injury who are seeking rapid treatment. Participants should be eligible based on specific criteria set by the study, which aren't detailed here.

What is being tested?

The trial tests an accelerated TMS protocol aimed at quickly reducing PTSD symptoms through 25 sessions over a week using different types of brain stimulation coils, some real and some sham (placebo).

What are the potential side effects?

Possible side effects may include discomfort at the coil placement site, headache, lightheadedness, or seizures; however, exact side effects are not provided in this summary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am fluent in English.

Select...

I do not have conditions like metal in my head or seizures that prevent neuromodulation.

Select...

I do not have dementia or cognitive issues affecting my treatment participation.

Select...

I do not have any unstable health conditions that would make TMS treatment unsafe for me.

Select...

I have had a severe brain injury.

Select...

I cannot stop taking medication that increases my risk of seizures.

Select...

I have previously received TMS or ECT targeting the front part of my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessment of symptoms during the preceding week.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessment of symptoms during the preceding week.

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessment of symptoms during the preceding week. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to determine dm-PFC accel-TMS efficacy

Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to determine left dl-PFC accel-TMS efficacy

Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to determine superior symptom reduction

Secondary study objectives

Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to characterize durability of accel-TMS effects

Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to determine added benefit during Extension

Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to determine superior outcomes between active left dl-PFC and active dm-PFC accel-TMS

Trial Design

5Treatment groups

Active Control

Placebo Group

Group I: Arm 1: active left dl-PFC accel-TMSActive Control1 Intervention

Acute Phase: Eligible participants will be randomized into one of the three treatment groups: active left dl-PFC accel-TMS vs. active dm-PFC accel-TMS vs. sham dl-PFC/dm-PFC accel TMS

Group II: Arm 2:active dm-PFC accel-TMSActive Control1 Intervention

Acute Phase: Eligible participants will be randomized into one of the three treatment groups: active left dl-PFC accel-TMS vs. active dm-PFC accel-TMS vs. sham dl-PFC/dm-PFC accel TMS

Group III: Arm 5Active Control1 Intervention

Extension phase, all participants will receive active left dl-PFC accel-TMS.

Group IV: Arm 3 - sham accel-TMS dl-PFCPlacebo Group1 Intervention

Acute Phase: Eligible participants will be randomized into one of the three treatment groups: active left dl-PFC accel-TMS vs. active dm-PFC accel-TMS vs. sham dl-PFC/dm-PFC accel TMS

Group V: Arm 4: sham accel -TMS dm-PFCPlacebo Group1 Intervention

Acute Phase: Eligible participants will be randomized into one of the three treatment groups: active left dl-PFC accel-TMS vs. active dm-PFC accel-TMS vs. sham dl-PFC/dm-PFC accel TMS

0 / 8Eligibility criteria met