Synchronized Transcranial Magnetic Stimulation for PTSD

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Providence VA Medical Center
Study ID
NCT02981381
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • NEST-1 — DEVICE
    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.
  • SHAM — DEVICE
    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.
  • NEST-2 — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Oct 13, 2016
Status verified
May 2025
Primary completion
Oct 26, 2018
Completion
Oct 26, 2018

Study Design

Enrollment
23 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active sTMS (NEST-1)
    Subjects randomized to this group will receive 20 active synchronized Transcranial Magnetic Stimulation (sTMS) treatments (30 minutes each) over a period of 40 calendar days. Treatment windows will be 10 calendar days to complete 5 active sTMS sessions. Serial assessments will be completed every 5 sessions. Post-treatment (PT1) endpoint assessments will take place on the last day of active sTMS. Participants that elect to participate in the open-label continuation phase, will receive an additional 20 sTMS treatments (using the NEST-2 device), following the same administration structure as the sham-control series. Participants will return to complete post-treatment follow-up assessments (PT2) 1 month after their last treatment session (either PT1 or OL PT1).
  • Sham Comparator: Sham sTMS (SHAM)
    Subjects randomized to this group will receive 20 sham synchronized Transcranial Magnetic Stimulation (sTMS) treatments (30 minutes each) over a period of 40 calendar days. Treatment windows will be 10 calendar days to complete 5 sham sessions. Serial assessments will be completed every 5 sessions. Post-treatment (PT1) endpoint assessments will take place immediately after the final sham session. Participants that elect to participate in the open-label continuation phase, will receive 20 sTMS treatments (using the NEST-2 device), following the same administration structure as the sham-control series. Participants will return to complete post-treatment follow-up assessments (PT2) 1 month after their last treatment session (either PT1 or OL PT1).

Primary Outcome Measure

PCL-5 Total Score Change [ Time Frame: 1 month after final treatment (approximately 70 days total) ]

Locations (2)

FacilityCityStateZIPSite coordinators
Providence VAMCProvidenceRhode Island02906-
White River Junction VAMCWhite River JunctionVermont05009-

Find similar trials in Providence, RI

By condition
DepressionPTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
Providence VAMC· Providence, RIWhite River Junction VAMC· White River Junction, VT

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