PTSDsTMSNCT02981381
Synchronized Transcranial Magnetic Stimulation for PTSD
A study testing NEST-1 and NEST-2 in people with PTSD and Depression, run by Providence VA Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- PTSD, Depression
- What is being tested?
- NEST-1 and NEST-2
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Oct 2016to 26 Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Providence VAMC
Providence, Rhode Island, 02906
White River Junction VAMC
White River Junction, Vermont, 05009
About this study
Official title: Synchronized TMS for Posttraumatic Stress Disorder and Comorbid Depressive Symptoms
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.
Read the 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
- Being tested
- NEST-1, SHAM, NEST-2
- Keywords
- sTMS, NeoSync, NEST, synchronous, non-invasive neuromodulation, TMS, Transcranial Magnetic Stimulation, PTSD, EEG, Depression
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEST-1Device
Also called Active sTMS, NeoSync EEG Synchronized TMS
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.
SHAMDevice
Also called NEST-1 Sham Comparator
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-2Device
Also called Open-label sTMS, NeoSync EEG Synchronized TMS
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 group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Device: SHAM; Device: NEST-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month after final treatment (approximately 70 days total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study start13 Oct 2016
- Primary completion26 Oct 2018
- Study completion26 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Wave Neuroscience
- Responsible party
- Principal investigator, Noah S. Philip, MD, Providence VA Medical Center
- Investigators
- Noah S Philip, MD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02981381
- Sponsor's protocol ID
- 2016-004
- Other IDs
- 1010584-1
- Acronym
- sTMS
- Status last verified
- May 2025
- First submitted
- 24 Oct 2016
- Last updated
- 17 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synchronized TMS for Posttraumatic Stress Disorder and Comorbid Depressive Symptoms
- ClinicalTrials.gov ID
- NCT02981381
- Acronym / sponsor ID
- sTMS / 2016-004
- Conditions
- PTSD, Depression
- Keywords
- sTMS, NeoSync, NEST, synchronous, non-invasive neuromodulation, TMS, Transcranial Magnetic Stimulation, PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Providence VA Medical CenterUS federal agency
- Collaborators
- Wave Neuroscience
- Study start
- 13 Oct 2016 (actual)
- Primary completion
- 26 Oct 2018 (actual)
- Study completion
- 26 Oct 2018 (actual)
- First posted
- 5 Dec 2016 (estimated)
- Results
- Posted 17 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active sTMS (NEST-1) | Experimental | Device: NEST-1, Device: NEST-2Subjects 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 sTMS (SHAM) | Sham comparator | Device: SHAM, Device: NEST-2Subjects 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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NEST-1Also: Active sTMS, NeoSync EEG Synchronized TMSThe 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 | Active sTMS (NEST-1) |
| SHAMAlso: NEST-1 Sham ComparatorThe 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 | Sham sTMS (SHAM) |
| NEST-2Also: Open-label sTMS, NeoSync EEG Synchronized TMSThe 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. | Device | Active sTMS (NEST-1), Sham sTMS (SHAM) |
Primary outcome
PCL-5 Total Score Change
Time frame: 1 month after final treatment (approximately 70 days total)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noah S Philip, MD principal investigator
Study Principal Investigator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEST-1 and NEST-2 in people with PTSD and Depression, run by Providence VA Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PCL-5 Total Score Change (time frame: 1 month after final treatment (approximately 70 days total)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.