Rapid Treatment of PTSD With Accelerated Non-Invasive Brain Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to determine left dl-PFC accel-TMS efficacy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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) -
研究组 & 干预措施
Arm 5
Extension phase, all participants will receive active left dl-PFC accel-TMS.
干预措施: Cool B70 Treatment Coil - Active Only (Device)
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
干预措施: Cool B70 AP Coil - Active (dl-PFC) (Device)
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
干预措施: Cool D-B80 AP Coil - Active (dm-PFC) (Device)
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
干预措施: Cool B70 AP Coil- Sham (dl-PFC) (Device)
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
干预措施: Cool D-B80 AP Coil - Sham (dm-PFC) (Device)
结局指标
主要结局
Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to determine left dl-PFC accel-TMS efficacy
时间窗: Assessment of symptoms during the preceding week.
CAPS-V is a 30-item clinical interview used to diagnose PTSD as well as monitor PTSD symptoms. Questions address the traumatic event(s), symptom duration, subjective distress, impact on functioning, dissociation, and symptom improvement since last evaluation. During the Acute Phase, CAPS-V will be used to determine the rapid efficacy of left dl-PFC accel-TMS compared to sham accel-TMS at approximately one-week post-treatment.
Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to determine dm-PFC accel-TMS efficacy
时间窗: Assessment of symptoms during the preceding week.
A 30-item clinical interview used to diagnose PTSD as well as monitor PTSD symptoms. Questions address the traumatic event(s), symptom duration, subjective distress, impact on functioning, dissociation, and symptom improvement since last evaluation. During the Acute Phase, CAPS-V will be used to determine the rapid efficacy of dm-PFC accel-TMS compared to sham accel-TMS at approximately one-week post-treatment
Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to determine superior symptom reduction
时间窗: Assessment of symptoms during the preceding week.
A 30-item clinical interview used to diagnose PTSD as well as monitor PTSD symptoms. Questions address the traumatic event(s), symptom duration, subjective distress, impact on functioning, dissociation, and symptom improvement since last evaluation. During the Extension Phase, CAPS-V will be used to determine whether an additional week of left dl-PFC accel-TMS provides superior reduction of PTSD symptoms compared to one week of left dl-PFC accel-TMS.
次要结局
- Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to characterize durability of accel-TMS effects(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(Assessment of symptoms during the preceding week.)
- Clinician-Administered PTSD Scale for DSM-V (CAPS-V) to determine added benefit during Extension(Assessment of symptoms during the preceding week.)
研究者
F. Andrew Kozel
Principal Investigator
Florida State University