Rapid Treatment of PTSD With Accelerated Non-Invasive Brain Stimulation

Overview

This study will test the clinical efficacy of an accelerated TMS (accel-TMS) protocol that rapidly addresses PTSD symptoms with 1 week (25 sessions over 5 days) of condensed treatment.

Detailed description

This study will have three phases: an acute phase (1 week of treatments), an extension phase (second week of treatments), and a long-term observational follow-up phase of 6 months.

The acute phase will be a three-arm randomized sham-controlled trial with: Arm 1 = active left dl-PFC accel-TMS; Arm 2 = active dm-PFC accel-TMS; and Arm 3 = sham accel-TMS (half with sham dl-PFC and half with sham dm-PFC coil positioning).

In the subsequent extension phase, all participants will receive active left dl-PFC accel-TMS. For the follow-up phase, clinical outcomes will be assessed at 1-month, 3-months, and 6-months. The primary outcome measure will be the CAPS-5.

A range of other secondary outcome measures will also be included.

Interventions

• Device Cool B70 AP Coil - Active (dl-PFC)
  One side of the coil is the active and the other is sham. The B70 AP coil will be positioned over the left dorsolateral prefrontal cortex (dl-PFC).
• Device Cool B70 AP Coil- Sham (dl-PFC)
  One side of the coil is the active and the other is sham. The B70 AP coil will be positioned over the left dorsolateral prefrontal cortex (dl-PFC).
• Device Cool D-B80 AP Coil - Active (dm-PFC)
  One side of the coil is the active and the other is sham. The cool D-B80 AP coil will be positioned over the midline (bilateral) dorsal medial prefrontal cortex (dmPFC) using location 25.8% distance from nasion to inion.
• Device Cool D-B80 AP Coil - Sham (dm-PFC)
  One side of the coil is the active and the other is sham. The cool D-B80 AP coil will be positioned over the midline (bilateral) dorsal medial prefrontal cortex (dmPFC) using location 25.8% distance from nasion to inion.
• Device Cool B70 Treatment Coil - Active Only
  The treatment will be the same as the left dl-PFC accel-TMS dl-PFC except that the Cool B70 Treatment coil only has an active treatment coil.

Primary outcome measures

• Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to determine left dl-PFC accel-TMS efficacy [Time frame: Assessment of symptoms during the preceding week.]
• Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to determine dm-PFC accel-TMS efficacy [Time frame: Assessment of symptoms during the preceding week.]
• Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to determine superior symptom reduction [Time frame: Assessment of symptoms during the preceding week.]

Secondary outcome measures (3)

• Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to characterize durability of accel-TMS effects [Time frame: Assessment of symptoms during the preceding week before each follow-up visit.]
• Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to determine superior outcomes between active left dl-PFC and active dm-PFC accel-TMS [Time frame: Assessment of symptoms during the preceding week.]
• Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to determine added benefit during Extension [Time frame: Assessment of symptoms during the preceding week.]

Eligibility criteria

Inclusion:

• Adults age 18 years to 65 years old.
• Meets DSM-5 criteria for PTSD with a PCL-5 score > 33
• No changes in psychotropic medication (if taking psychotropic medication) and/or changes in supportive psychotherapy for 1 month prior to initial visit; and clinically appropriate to maintain stable treatment regimen for duration of trial.
• Clinically competent to give informed written consent and ability to understand study procedures and to comply with them for the entire length of the study

Exclusion:

• Medical contraindication for neuromodulation (e.g., ferrous metal in head, seizure disorder, brain tumor, stroke, aneurysm, multiple sclerosis, etc.).
• Active substance use disorder in last 3 months or any current substance use that puts the participant at increased risk or significant impairment.
• Dementia or other cognitive disorder making unable to engage in treatment.
• Any history or diagnosis of Schizophrenia, Schizoaffective Disorder, Delusional Disorder or other psychotic illness that precludes safe participation in trial.
• Suicidal risk that precludes safe participation defined as clinical impression that the participant is at significant risk for suicide.
• OCD cannot be the primary disorder but can have OCD symptoms.
• Inability to stop taking any medication that significantly lowers the seizure threshold (e.g., tricyclic antidepressants, clozapine, etc.)
• Current, planned, or suspected pregnancy
• Unstable medical conditions or any current medical condition that could preclude being able to safely participate in TMS treatment (e.g., unstable metabolic abnormality, unstable angina, etc.)
• Severe Traumatic Brain Injury
• We will exclude non-English speakers because of the need for rapid communication during the delivery of treatments.
• Significant ongoing litigation or claims that impact research activities, as determined by the research study team. (Research may especially be impacted when mental health or pain is being evaluated for litigation or claims, such as civil and criminal cases, disability claims and worker's compensation).
• Prior known active TMS of dorsolateral prefrontal cortex or dorsomedial prefrontal cortex or electroconvulsive therapy (ECT) -

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Other

Study locations

United States · 1 center

• Florida State University — Tallahassee

Identifiers

NCT: NCT06544408 · STUDY00005179 · CDMRP-TP230396

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗