NCT02981381

Synchronized Transcranial Magnetic Stimulation for PTSD

Synchronized TMS for Posttraumatic Stress Disorder and Comorbid Depressive Symptoms

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Providence VA Medical Center · Federal
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• PTSD
• Depression

Interventions

Type	Name	Description
DEVICE	NEST-1	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.
DEVICE	SHAM	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.
DEVICE	NEST-2	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.

Timeline

• Start date: 2016-10-13
• Primary completion: 2018-10-26
• Completion: 2018-10-26
• First posted: 2016-12-05
• Last updated: 2025-06-17
• Results posted: 2025-06-17

Locations

2 sites across 1 country: United States