DepressionNCT05682677
Combined Neuromodulation and Cognitive Training for Post-mTBI Depression
A study testing iTBS and Personalized, Augmented Cognitive Training (PACT) in people with Depression and Mild Traumatic Brain Injury, run by University of California, San Diego at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Mild Traumatic Brain Injury, Concussion, Brain
- What is being tested?
- iTBS and Personalized, Augmented Cognitive Training (PACT)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2023to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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 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
- 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
- Active manic or psychotic illness per MINI
- Current substance use disorder per MINI
- Current active suicidal or homicidal ideation
Show all 12Show fewer
- 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 efficacy
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UCSD
La Jolla, California, 92093
Michelle Schy, 858-642-3848, mschy@health.ucsd.edu
Janae Wyckoff, 858-642-3848, jwyckoff@health.ucsd.edu
About this study
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. Assessments will occur at baseline, 2 weeks, 4 weeks, and 8 weeks. Researchers will compare the PACT+iTBS group to the PACT+sham iTBS group to see if PACT+iTBS is associated with more depression improvement.
- Conditions
- Depression, Mild Traumatic Brain Injury, Concussion, Brain
- Being tested
- iTBS, sham iTBS, Personalized, Augmented Cognitive Training (PACT)
- Keywords
- brain stimulation, neuromodulation, transcranial magnetic stimulation, theta burst stimulation, TMS, TBS, rTMS, iTBS, cognitive training, cognitive rehabilitation
- Medical subject headings
- Depression, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iTBSDevice
iTBS over the left dorsolateral prefrontal cortex
sham iTBSDevice
sham iTBS over the left dorsolateral prefrontal cortex
Personalized, Augmented Cognitive Training (PACT)Behavioural
6 sessions of PACT
| Study group | Role | What they receive |
|---|---|---|
| PACT+iTBS | Experimental | Personalized, Augmented Cognitive Training (PACT; 6 sessions over 4 weeks) + intermittent theta burst stimulation (iTBS; 20 sessions over 4 weeks) Receives: Device: iTBS; Behavioral: Personalized, Augmented Cognitive Training (PACT) |
| PACT+sham iTBS | Sham comparator | Personalized, Augmented Cognitive Training (PACT; 6 sessions over 4 weeks) + sham intermittent theta burst stimulation (sham iTBS; 20 sessions over 4 weeks) Receives: Device: sham iTBS; Behavioral: Personalized, Augmented Cognitive Training (PACT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale for Depression
Measured: change over 8 weeks
Secondary outcomes (16)
Patient Health Questionnaire-9
Measured: change over 8 weeks
Neurobehavioral Symptom Inventory
Measured: change over 8 weeks
PTSD Checklist for DSM-5
Measured: change over 8 weeks
Headache Impact Test
Measured: change over 8 weeks
Pittsburgh Sleep Quality Index
Measured: change over 8 weeks
WHO Disability Assessment Schedule
Measured: change over 8 weeks
Glasgow Outcome Scale - Extended
Measured: change over 8 weeks
PROMIS Cognitive Function Abilities Short Form
Measured: change over 8 weeks
Patient Global Impression of Change
This measure asks the participant to rate their status since the start of the study from 1 (very much improved) to 7 (very much worse)
Measured: rating at 8 weeks
Traumatic Brain Injury Quality of Life
The Traumatic Brain Injury Quality of Life The Traumatic Brain Injury Quality of Life measurement system (TBI-QOL) is a TBI-specific extension of the NIH PROMIS and Neuro-QoL measures that includes 20 items measuring physical, emotional, social, and cognitive domains
Measured: change over 8 weeks
D-KEFS Trail Making Test
Measured: change over 8 weeks
D-KEFS Color Word Interference Test
Measured: change over 8 weeks
WMS-IV Digit Span
Measured: change over 8 weeks
WAIS-IV Processing Speed
Measured: change over 8 weeks
Hopkins Verbal Learning Test - Revised
Measured: change over 8 weeks
UCSD Performance-Based Skills Assessment-Brief
The UCSD Performance-Based Skills Assessment-Brief is a performance-based measure that uses role play scenarios to assess capacity for financial and communication tasks.
Measured: change over 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start19 Sep 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- San Diego Veterans Healthcare System
- Responsible party
- Principal investigator, Elizabeth Twamley, University of California, San Diego
- Investigators
- Elizabeth Twamley, PhD, Principal investigator, UC San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682677
- Sponsor's protocol ID
- W81XWH-22-2-0045
- Status last verified
- Apr 2026
- First submitted
- 4 Jan 2023
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: IPD will be available via FITBIR.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Neuromodulation and Cognitive Training for Post-mTBI Depression
- ClinicalTrials.gov ID
- NCT05682677
- Acronym / sponsor ID
- W81XWH-22-2-0045
- Conditions
- Depression, Mild Traumatic Brain Injury, Concussion, Brain
- Keywords
- brain stimulation, neuromodulation, transcranial magnetic stimulation, theta burst stimulation, TMS, TBS, rTMS, iTBS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- San Diego Veterans Healthcare System
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Assessments will occur at baseline, 2 weeks, 4 weeks, and 8 weeks. Researchers will compare the PACT+iTBS group to the PACT+sham iTBS group to see if PACT+iTBS is associated with more depression improvement.
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 |
|---|---|---|
| PACT+iTBS | Experimental | Device: iTBS, Behavioral: Personalized, Augmented Cognitive Training (PACT)Personalized, Augmented Cognitive Training (PACT; 6 sessions over 4 weeks) + intermittent theta burst stimulation (iTBS; 20 sessions over 4 weeks) |
| PACT+sham iTBS | Sham comparator | Device: sham iTBS, Behavioral: Personalized, Augmented Cognitive Training (PACT)Personalized, Augmented Cognitive Training (PACT; 6 sessions over 4 weeks) + sham intermittent theta burst stimulation (sham iTBS; 20 sessions over 4 weeks) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (12 listed)
- 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 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
- 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
- Active manic or psychotic illness per MINI
- Current substance use disorder per MINI
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 |
|---|---|---|
| iTBSiTBS over the left dorsolateral prefrontal cortex | Device | PACT+iTBS |
| sham iTBSsham iTBS over the left dorsolateral prefrontal cortex | Device | PACT+sham iTBS |
| Personalized, Augmented Cognitive Training (PACT)6 sessions of PACT | Behavioural | PACT+iTBS, PACT+sham iTBS |
Primary outcome
Hamilton Rating Scale for Depression
Time frame: change over 8 weeks
16 secondary outcomes
Patient Health Questionnaire-9
Time frame: change over 8 weeks
Neurobehavioral Symptom Inventory
Time frame: change over 8 weeks
PTSD Checklist for DSM-5
Time frame: change over 8 weeks
Headache Impact Test
Time frame: change over 8 weeks
Pittsburgh Sleep Quality Index
Time frame: change over 8 weeks
WHO Disability Assessment Schedule
Time frame: change over 8 weeks
Glasgow Outcome Scale - Extended
Time frame: change over 8 weeks
PROMIS Cognitive Function Abilities Short Form
Time frame: change over 8 weeks
Patient Global Impression of Change
Time frame: rating at 8 weeks
Traumatic Brain Injury Quality of Life
Time frame: change over 8 weeks
D-KEFS Trail Making Test
Time frame: change over 8 weeks
D-KEFS Color Word Interference Test
Time frame: change over 8 weeks
WMS-IV Digit Span
Time frame: change over 8 weeks
WAIS-IV Processing Speed
Time frame: change over 8 weeks
Hopkins Verbal Learning Test - Revised
Time frame: change over 8 weeks
UCSD Performance-Based Skills Assessment-Brief
Time frame: change over 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Yes. IPD will be available via FITBIR.
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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.
Elizabeth Twamley, PhD principal investigator
UC San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iTBS and Personalized, Augmented Cognitive Training (PACT) in people with Depression and Mild Traumatic Brain Injury, run by University of California, San Diego at 1 site 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 13 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Schy (858-642-3848, mschy@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Rating Scale for Depression (time frame: change over 8 weeks). 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 1 May 2026.