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NCT06081309

EEG Personalized Transcranial Magnetic Stimulation (eTMS) for Post-Traumatic Stress Disorder

Completed NA Results posted Last updated 19 March 2025
What this trial tests

NA trial testing EEG-based personalized TMS in Stress Disorders, Post-Traumatic in 30 participants. Completed in 16 May 2024.

Timeline
20 November 2023
Primary endpoint
16 May 2024
16 May 2024

Quick facts

Lead sponsorWave Neuroscience
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment30
Start date20 November 2023
Primary completion16 May 2024
Estimated completion16 May 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Wave Neuroscience

Who can join

Adults 22 to 65, any sex, with Stress Disorders, Post-Traumatic. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number, Severity, Relatedness, Type, Subsequent Treatment/Intervention Required, and Resolution Status of Adverse Events (AEs) During the Study. Primary · Baseline and Final Measure, between 10-21 Days

Number - Number of adverse events reported. Note that each participant may have had more than one adverse event (AE). Severity - Number of adverse events that were mild, moderate, or severe. Relatedness - Number of adverse events that were not related, suspected, or definitely related to treatment. Type - Number of adverse events that were or were not Serious Adverse Events (SAEs). Subsequent treatment/intervention required - Number of adverse events that did or did not require subsequent treatment/intervention. Number of participants reporting at least one AE

Adverse Event Intensity - Mild
GroupValue95% CI
Open-Label Active EEG-based Personalized TMS Treatment26
Adverse Event Intensity - Moderate
GroupValue95% CI
Open-Label Active EEG-based Personalized TMS Treatment3
Adverse Event Intensity - Severe
GroupValue95% CI
Open-Label Active EEG-based Personalized TMS Treatment2
Adverse Event Relationship to Treatment - Not Related
GroupValue95% CI
Open-Label Active EEG-based Personalized TMS Treatment17
Adverse Event Relationship to Treatment - Suspected
GroupValue95% CI
Open-Label Active EEG-based Personalized TMS Treatment5
Adverse Event Relationship to Treatment - Definitely Related
GroupValue95% CI
Open-Label Active EEG-based Personalized TMS Treatment9
Serious Adverse Event
GroupValue95% CI
Open-Label Active EEG-based Personalized TMS Treatment0
Not a Serious Adverse Event
GroupValue95% CI
Open-Label Active EEG-based Personalized TMS Treatment31
Improvement in PTSD Symptoms as Measured by Drop in Score on the PTSD Checklist for DSM-5 (PCL-5) Secondary · Baseline and Final Measure, between 10-21 Days

The Post Traumatic Stress Disorder (PTSD) Checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th Ed. (DSM-5), commonly referred to as PCL-5, is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. It is used to monitor symptom change during and after treatment. Each item is scored from 0 to 5 as the participant's estimate of the severity of the symptom (0 = Not at all, 1=A little bit, 2 = Moderately, 3 = Quite a bit, 4 = Extremely). The final score range is between 0-80. A lower score is considered better than a higher score.

Baseline Measure
GroupValue95% CI
Open-Label Active EEG-based Personalized TMS Treatment52.2± 8.9
Final Measure
GroupValue95% CI
Open-Label Active EEG-based Personalized TMS Treatment22.9± 14.0
Change between Baseline and Final Measure
GroupValue95% CI
Open-Label Active EEG-based Personalized TMS Treatment29.3± 13.1
Number of Participants With at Least One Adverse Event Secondary · Baseline and Final Measure, between 10-21 Days

The number of participants who experienced at least one Adverse Event in the study

GroupValue95% CI
Open-Label Active EEG-based Personalized TMS Treatment14

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline and Final Measure, between 10-21 Days. In addition, any adverse events that occurred after the Final Measure until Study completion were included.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Open-Label Active EEG-based Personalized TMS Treatment
Serious: 0/30 (0%)
Deaths: 0/30
Other adverse events (10 terms — click to expand)

ReactionSystemOpen-Label Active EEG-base…
HeadacheGeneral disorders
Mild HeadacheGeneral disorders
Sinus HeadacheGeneral disorders
NauseaGastrointestinal disorders
IrritabilityGeneral disorders
Mild Head ColdGeneral disorders
BruiseGeneral disorders
Short-term SadnessNervous system disorders
Local Site PainSkin and subcutaneous tissue disorders
ConjunctivitisEye disorders

Data from ClinicalTrials.gov NCT06081309 adverse events section.

Sponsor's own description

This is an open-label safety pilot study of the Electroencephalogram (EEG) Transcranial Magnetic Stimulation (eTMS) treatment for Post-Traumatic Stress Disorder (PTSD). The recruitment goal is 30 participants who are United States Military veterans or first responders (e.g., firefighters, police, paramedics, etc.). The Study includes an EEG recording in order to determine the optimal treatment parameters for the eTMS system, followed by 10 in-office visits that take place over 21 total days. Two eTMS treatment sessions are administered during each office visit.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of EEG-based personalized TMS

Trials testing the same drug.

Other recruiting trials for Stress Disorders, Post-Traumatic

Currently open trials in the same condition.

Other Wave Neuroscience trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06081309.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing