RECRUITING

Combined Neuromodulation and Cognitive Training for Post-mTBI Depression

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Combined Neuromodulation and Cognitive Training for Post-mTBI Depression

Quick Facts

Study Start:2023-09-19
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05682677

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female
  2. 2. All racial and ethnic groups
  3. 3. Ages 18 to 65
  4. 4. Military service members receiving treatment at NMCSD or civilians receiving treatment at UCSD Health
  5. 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. 6. Meets criteria for current Major Depressive Episode within the context of Major Depressive Disorder, per MINI
  7. 7. Score of 18 or higher on the HAMD-17, indicating moderate to severe depressive symptoms
  8. 8. Stable on psychiatric medications for 6 weeks, with no changes to psychiatric medications expected during the study period
  9. 9. No contraindications to TMS (passes the TMS Adult Safety Screening questionnaire)
  10. 10. No contraindications to MRI (passes MRI safety screening questionnaire)
  11. 11. Able to commit to the treatment schedule
  12. 12. Able to complete assessment procedures in English
  13. 13. Intact decision-making capacity and ability to provide voluntary informed consent
  1. 1. History of moderate, severe, or penetrating TBI
  2. 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. 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. 4. Active manic or psychotic illness per MINI
  5. 5. Current substance use disorder per MINI
  6. 6. Current active suicidal or homicidal ideation
  7. 7. Pregnant or intending to become pregnant within the study period; breastfeeding
  8. 8. Other sensory conditions or illnesses precluding participation in assessments or treatment
  9. 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. 10. Taking medication that lowers seizure threshold
  11. 11. Previous failed treatment with rTMS, iTBS, or ECT
  12. 12. Completed \>4 sessions of cognitive rehabilitation within the last 3 years

Contacts and Locations

Study Contact

Michelle Schy
CONTACT
858-642-3848
mschy@health.ucsd.edu
Janae Wyckoff
CONTACT
858-642-3848
jwyckoff@health.ucsd.edu

Principal Investigator

Elizabeth Twamley, PhD
PRINCIPAL_INVESTIGATOR
UC San Diego

Study Locations (Sites)

UCSD
La Jolla, California, 92093
United States

Collaborators and Investigators

Sponsor: University of California, San Diego

  • Elizabeth Twamley, PhD, PRINCIPAL_INVESTIGATOR, UC San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-19
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2023-09-19
Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

  • brain stimulation
  • neuromodulation
  • transcranial magnetic stimulation
  • theta burst stimulation
  • TMS
  • TBS
  • rTMS
  • iTBS
  • cognitive training
  • cognitive rehabilitation

Additional Relevant MeSH Terms

  • Depression
  • Mild Traumatic Brain Injury
  • Concussion, Brain