New combo therapy targets post-concussion depression in veterans and civilians
NCT ID NCT05682677
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new approach for treating depression in people who have had a mild traumatic brain injury (concussion). Participants will receive a personalized cognitive training program combined with either real or sham brain stimulation over 4 weeks. The goal is to see if the combination leads to greater improvement in depression symptoms. The study includes 72 military members, veterans, and civilians aged 18 to 65.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 72 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Sep 2023
- Expected to finish
-
Jun 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female 2. All racial and ethnic groups 3. Ages 18 to 65 4. Military service members receiving treatment at NMCSD or civilians receiving treatment at UCSD Health 5. History of mild TBI (as defined by the DoD/VA criteria used in conjunction with the OSU TBI-ID method) over 3 months prior to study entry 6. Meets criteria for current Major Depressive Episode within the context of Major Depressive Disorder, per MINI 7. Score of 18 or higher on the HAMD-17, indicating moderate to severe depressive symptoms 8. Stable on psychiatric medications for 6 weeks, with no changes to psychiatric medications expected during the study period 9. No contraindications to TMS (passes the TMS Adult Safety Screening questionnaire) 10. No contraindications to MRI (passes MRI safety screening questionnaire) 11. Able to commit to the treatment schedule 12. Able to complete assessment procedures in English 13. Intact decision-making capacity and ability to provide voluntary informed consent Exclusion Criteria: 1. History of moderate, severe, or penetrating TBI 2. History of other neurological condition unrelated to TBI, including but not limited to: conditions associated with increased intracranial pressure; space occupying brain lesions; cerebral aneurysm; stroke; transient ischemic attack within past two years; Parkinson's disease; Huntington's disease; dementia; multiple sclerosis; history of brain surgery; epilepsy; seizure except those therapeutically induced by electroconvulsive therapy (ECT) or a febrile seizure of infancy 3. Implanted medical devices including cardiac pacemaker, medication pump, aneurysm clip, shunt, stimulator, cochlear implant, electrodes, or any other metal object within or near the head (excluding the mouth) that cannot be safely removed 4. Active manic or psychotic illness per MINI 5. Current substance use disorder per MINI 6. Current active suicidal or homicidal ideation 7. Pregnant or intending to become pregnant within the study period; breastfeeding 8. Other sensory conditions or illnesses precluding participation in assessments or treatment 9. Current dose of lorazepam 2 mg or greater daily (or benzodiazepine equivalent) or any anticonvulsant due to the potential to limit iTBS efficacy 10. Taking medication that lowers seizure threshold 11. Previous failed treatment with rTMS, iTBS, or ECT 12. Completed \>4 sessions of cognitive rehabilitation within the last 3 years
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Concussion, brain are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
UCSD
RECRUITINGLa Jolla, California, 92093, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- The dynamic mechanism of mindfulness intervention for emotional distress (MIED) based on ecological moment measurement
- Role of self-focused attention in depression
- Project QUIT+: adapting and testing a smoking cessation intervention for transgender and gender expansive individuals
- Can a nudge toward healthy habits boost an online depression and anxiety program?
- Targeting the brain's reward system: a new test for depression treatment
- Can brain activity reveal why some people with depression lose motivation and pleasure?