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New treatment option for Depression
Official title Combined Neuromodulation and Cognitive Training for Post-mTBI Depression
ClinicalTrials.gov ID: NCT05682677
What this study is testing
- What it's testing
- The primary goal of this clinical trial is to evaluate whether Personalized Augmented Cognitive Training (PACT) plus intermittent theta burst stimulation (iTBS) is effective for treating depression in Service Members, Veterans, and civilians who have sustained a mild TBI. Participants will receive PACT plus 20 sessions of iTBS or sham iTBS over 4 weeks.
- Time commitment: about 4 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Male or female
- All racial and ethnic groups
- Ages 18 to 65
- Military service members receiving treatment at NMCSD or civilians receiving treatment at UCSD Health
- 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
You likely can't join if
- History of moderate, severe, or penetrating TBI
- History of other neurological condition unrelated to TBI, including but not limited to: conditions associated with increased intracranial pressure...
- Implanted medical devices including cardiac pacemaker, medication pump, aneurysm clip, shunt, stimulator, cochlear implant, electrodes, or any other...
- Active manic or psychotic illness per MINI
- Current substance use disorder per MINI
- Current active suicidal or homicidal ideation
See the full eligibility criteria
- Male or female
- All racial and ethnic groups
- Ages 18 to 65
- Military service members receiving treatment at NMCSD or civilians receiving treatment at UCSD Health
- 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
- Meets criteria for current Major Depressive Episode within the context of Major Depressive Disorder, per MINI
- Score of 18 or higher on the HAMD-17, indicating moderate to severe depressive symptoms
- Stable on psychiatric medications for 6 weeks, with no changes to psychiatric medications expected during the study period
- No contraindications to TMS (passes the TMS Adult Safety Screening questionnaire)
- No contraindications to MRI (passes MRI safety screening questionnaire)
- Able to commit to the treatment schedule
- Able to complete assessment procedures in English
- Intact decision-making capacity and ability to provide voluntary informed consent
- History of moderate, severe, or penetrating TBI
- 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...
- 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...
- Active manic or psychotic illness per MINI
- Current substance use disorder per MINI
- Current active suicidal or homicidal ideation
- Pregnant or intending to become pregnant within the study period; breastfeeding
- Other sensory conditions or illnesses precluding participation in assessments or treatment
- Current dose of lorazepam 2 mg or greater daily (or benzodiazepine equivalent) or any anticonvulsant due to the potential to limit iTBS how well it works
- Taking medication that lowers seizure threshold
- Previous failed treatment with rTMS, iTBS, or ECT
- Completed \>4 sessions of cognitive rehabilitation within the last 3 years
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.