Synchronized Transcranial Magnetic Stimulation for PTSD

NCT02981381 | Completed Results

• 2 other identifiers: 2016-0041010584-1
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

PTSD; Depression

Keywords

sTMS; NeoSync; NEST; synchronous; non-invasive neuromodulation; TMS; Transcranial Magnetic Stimulation; PTSD; EEG; Depression

Outcome Measures

Primary Outcomes (1)

• PCL-5 Total Score Change

  The PTSD checklist (PCL-5) will be used to assess PTSD symptom severity pre- and post-treatment. The change in total PCL-5 score from Baseline (Day 0) to endpoint (PT1) compared between active treatment and sham-controlled groups. If a participant does not complete PT1, last observation carried forward (LOCF) will be used. A 50% reduction in scores from Baseline scores to PT1 indicates clinical response to treatment (active sTMS vs. sham), and remission is defined by a post-treatment score below the threshold score published for the PCL-5. The PCL-5 (PTSD Checklist for DSM-5) is a 20-item self-report measure used to assess the presence and severity of posttraumatic stress disorder (PTSD) symptoms; scores go from 0 to 80, where higher scores indicate greater severity. A score greater than 33 is typically used to indicate severity sufficient for a PTSD diagnosis. Items are rated from 0 (Not at all) to 4 (extremely) bothersome.

  1 month after final treatment (approximately 70 days total)

Study Arms (2)

Active sTMS (NEST-1)

EXPERIMENTAL

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).

Device: NEST-1; Device: NEST-2

Sham sTMS (SHAM)

SHAM COMPARATOR

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).

Device: SHAM; Device: NEST-2

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.

Also known as: Active sTMS, NeoSync EEG Synchronized TMS

Active sTMS (NEST-1)

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.

Also known as: NEST-1 Sham Comparator

Sham sTMS (SHAM)

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.

Also known as: Open-label sTMS, NeoSync EEG Synchronized TMS

Active sTMS (NEST-1); Sham sTMS (SHAM)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be a Veteran;
• MRI safe;
• Meet Diagnostic and Statistical Manual, Fifth Edition (DSM 5) criterion for PTSD (acute or chronic, confirmed by the Clinician Administered PTSD Scale (CAPS) and at least moderate severity defined by a PCL-5 score \> 33); AND at least moderate depressive symptom severity (defined by QIDS-SR score \> or equal to 11) at baseline visit. Individuals with bipolar II or otherwise unspecified who are currently in a depressed episode are eligible;
• Baseline score of "moderately ill" or worse on the Clinical Global Impressions-Severity (CGI-S);
• Stable psychotropic regimen for at least 6 weeks prior to baseline and willing to maintain current dose and regimen throughout study, or no psychotropic medication at all;
• If female and of child bearing potential, must agree to use an acceptable method of birth control for the duration of the study treatment period;
• Be willing and able to comply with all study related procedures and visits;
• Be capable of independently reading and understanding all patient information materials and giving written informed consent.

You may not qualify if:

• Pregnant or lactating, or planning on becoming pregnant within the next 3 months;
• Lifetime history of loss of consciousness (\>10 minutes) due to head injury, or lifetime history of head injury with documented evidence of brain injury;
• Current (or past) significant neurological disorders (seizure disorder, primary or secondary central nervous system (CNS) tumors, stroke, cerebral aneurysm);
• Unstable medical illness, or significant absence of appropriate medical care;
• Current axis I primary psychotic disorder or Bipolar I disorder;
• Active (within the last month) moderate or severe substance (excluding nicotine/caffeine) abuse disorders. Individuals on stable (\>3 months), monitored opiate agonist therapy may be included at investigator's discretion;
• Past failed treatment with rTMS or electroconvulsive therapy (ECT); any past treatment with deep brain stimulation or vagus nerve stimulation;
• Have an active suicidal intent or plan, or in the opinion of the investigator, is likely to attempt suicide in the next 6 months;
• Presence of condition or circumstance with potential to prevent study completion;
• Inability to obtain sufficient EEG to calibrate study device.

Sponsors & Collaborators

• Providence VA Medical Center: lead
• Wave Neuroscience: collaborator

Study Sites (2)

Providence VAMC

Providence, Rhode Island, 02906, United States

Location

White River Junction VAMC

White River Junction, Vermont, 05009, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Noah S. Philip MD
• Organization: VA Providence

noah.philip@va.gov

401-273-7100

Study Officials

• Noah S Philip, MD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatrist

Study Record Dates

• First Submitted: October 24, 2016
• First Posted: December 5, 2016
• Study Start: October 13, 2016
• Primary Completion: October 26, 2018
• Study Completion: October 26, 2018
• Last Updated: June 17, 2025
• Results First Posted: June 17, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)