Synchronized Transcranial Magnetic Stimulation for PTSD
Condition: PTSD; Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators propose a small, two-site, sham-controlled pilot study of synchronized
      Transcranial Magnetic Stimulation (sTMS) in patients with comorbid post-traumatic stress
      disorder (PTSD) and depression. It is hypothesized that sTMS will be effective for PTSD and
      mood symptoms.
    

Detailed description: 
      Posttraumatic stress disorder (PTSD) is a highly prevalent psychiatric disorder associated
      with high degrees of comorbidity (e.g., major depressive disorder), poor quality of life, and
      significant social and occupational dysfunction. Currently available evidence-based
      pharmacological and psychological treatments for PTSD have only modest efficacy, and thus
      further research is necessary to develop treatment approaches in order to ameliorate the
      current disparity between disorder impact and prevalence, and effective therapies.

      The use of non-invasive neuromodulation techniques, such as repetitive transcranial magnetic
      stimulation (rTMS), in an outpatient setting, has shown to be effective in reducing symptoms
      in various mental disorders, including PTSD and major depressive disorder (MDD). Research
      examining the use of rTMS for PTSD still remain limited, the majority of findings pertain to
      rTMS in MDD cohorts, which excluded individuals with PTSD. Given the high rate of PTSD with
      MDD comorbidity, additional studies examining this comorbid population are necessary.

      Furthermore, rTMS treatment parameters and duration are rather time consuming for patients,
      requiring that patient travel to an outpatient facility daily, for 6 to 8 weeks, for 30 to 40
      minutes each day. This can be an inconvenience and poses an additional burden for individuals
      that already struggle with societal integration and social/occupational dysfunction. Thus,
      further exploration and development of non-invasive brain stimulatory devices with the same
      (or better) effectiveness as rTMS, that can be adapted to be utilized in an at home setting,
      would revolutionize the treatment of PTSD.

      The synchronized transcranial magnetic stimulation (sTMS, NeoSync Inc.) device provides the
      possibility of the fore mentioned therapeutic development. The sTMS device employs 3
      transversely rotating, to deliver low energy, sinusoidal magnetic fields synchronized to an
      individuals' intrinsic alpha frequency (IAF). Preliminary data has shown that sTMS can
      effectively reduce depressive symptoms in MDD. Additionally, the investigators' preliminary
      examination of IAF in participants with comorbid PTSD and depressive symptoms, has
      illuminated the feasibility of this modality as a treatment approach for PTSD comorbid with
      MDD.

      This study is a prospective, sham-controlled, trial of sTMS delivered to patients who are
      symptomatic despite ongoing pharmacotherapy for PTSD and mood symptoms. Eligible subjects
      will be randomized using to receive 4 weeks (5 daily sessions per week) of either sham or
      active sTMS treatment. Clinical and self-report assessments will be completed at baseline,
      sham/control series endpoint, and 1 month after the final treatment session. An optional
      open-label continuation phase will be offered to all study participants who complete the
      sham-control phase of this study, and additional endpoint assessments will be administered.
    

Intervention name(s): NEST-1; SHAM; NEST-2
Intervention type(s): Device; Device; Device
Intervention description(s): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of PTSD. The device includes an EEG recording module that is used to record individualized alpha frequency (IAF) on randomized personal passport modules (PPM) pre-assigned to be NEST-1 compatible.; The SHAM NeoSync EEG Synchronized TMS (NEST) is a device, identical to the active NEST-1 device, that is configured to simulate the delivery of active treatment without actively delivering sTMS therapy. The device includes an EEG recording module that is used to record individualized alpha frequency (IAF) on randomized personal passport modules (PPM) pre-assigned to be SHAM compatible.; The open-label NeoSync EEG Synchronized TMS (NEST) that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of PTSD. The device is distinct in both color and sound both SHAM and NEST-1 devices. PPMs corresponding with both SHAM and NEST-1 devices are compatible with the NEST-2 device.
Other intervention name(s): Active sTMS; NeoSync EEG Synchronized TMS; NEST-1 Sham Comparator; Open-label sTMS; NeoSync EEG Synchronized TMS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: sTMS; NeoSync; NEST; synchronous; non-invasive neuromodulation; TMS; Transcranial Magnetic Stimulation; PTSD; EEG; Depression