Summary

Eligibility
for people ages 18-65 (full criteria)
Location
at La Jolla, California
Dates
study started
estimated completion
Principal Investigator
by Elizabeth Twamley, PhD
Headshot of Elizabeth Twamley
Elizabeth Twamley

Description

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. 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.

Keywords

Depression, Mild Traumatic Brain Injury, Concussion, Brain, brain stimulation, neuromodulation, transcranial magnetic stimulation, theta burst stimulation, TMS, TBS, rTMS, iTBS, cognitive training, cognitive rehabilitation, Brain Injuries, Traumatic Brain Injuries, Brain Concussion, Depressive Disorder, Personalized, Augmented Cognitive Training (PACT), PACT+iTBS

Eligibility

You can join if…

Open to people ages 18-65

  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

You CAN'T join if...

  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

Location

  • UCSD
    La Jolla California 92093 United States

Lead Scientist at UCSD

  • Elizabeth Twamley, PhD
    Dr. Twamley earned a BA in Social Ecology at UC Irvine and a PhD in Clinical Psychology from Arizona State University. She completed her clinical psychology internship and postdoctoral fellowship at UCSD and joined the faculty of the Department of Psychiatry in 2003.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT05682677
Study Type
Interventional
Participants
Expecting 72 study participants
Last Updated