Rapid Treatment of PTSD With Accelerated Non-Invasive Brain Stimulation
Purpose
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.
Conditions
- Post Traumatic Stress Disorder
- Traumatic Brain Injury
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Criteria
Inclusion:
1. Adults age 18 years to 65 years old.
2. Meets DSM-5 criteria for PTSD with a PCL-5 score > 33
3. 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.
4. 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:
1. Medical contraindication for neuromodulation (e.g., ferrous metal in head, seizure
disorder, brain tumor, stroke, aneurysm, multiple sclerosis, etc.).
2. Active substance use disorder in last 3 months or any current substance use that
puts the participant at increased risk or significant impairment.
3. Dementia or other cognitive disorder making unable to engage in treatment.
4. Any history or diagnosis of Schizophrenia, Schizoaffective Disorder, Delusional
Disorder or other psychotic illness that precludes safe participation in trial.
5. Suicidal risk that precludes safe participation defined as clinical impression that
the participant is at significant risk for suicide.
6. OCD cannot be the primary disorder but can have OCD symptoms.
7. Inability to stop taking any medication that significantly lowers the seizure
threshold (e.g., tricyclic antidepressants, clozapine, etc.)
8. Current, planned, or suspected pregnancy
9. 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.)
10. Severe Traumatic Brain Injury
11. We will exclude non-English speakers because of the need for rapid communication
during the delivery of treatments.
12. 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).
13. Prior known active TMS of dorsolateral prefrontal cortex or dorsomedial prefrontal
cortex or electroconvulsive therapy (ECT) -
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
- Masking Description
- Blinding Procedures The participants, PI, Research Staff involved in TMS treatment, and staff performing the study procedures will be blinded to the participant's dl-PFC protocol assignment throughout the study.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Arm 1: active left dl-PFC accel-TMS |
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 |
|
|
Active Comparator Arm 2:active dm-PFC accel-TMS |
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 |
|
|
Sham Comparator Arm 3 - sham accel-TMS dl-PFC |
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 |
|
|
Sham Comparator Arm 4: sham accel -TMS dm-PFC |
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 |
|
|
Active Comparator Arm 5 |
Extension phase, all participants will receive active left dl-PFC accel-TMS. |
|
Recruiting Locations
Tallahassee, Florida 32306
More Details
- NCT ID
- NCT06544408
- Status
- Recruiting
- Sponsor
- Florida State University
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.