RECRUITING

Neuromodulation and Neurorehabilitation for mTBI

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Conditions

Mild Traumatic Brain InjuryPost Traumatic Stress DisordermTBIPTSDintermittent theta burst stimulationcognitive trainingneuroimaging

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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

This study will determine (i) the magnitude of immediate and sustained effects of a current clinical standard interactive computer attention processing training (APT) when combined with intermittent theta burst stimulation (iTBS), a type of repetitive transcranial magnetic stimulation and (ii) determine how APT + iTBS changes the neurocognitive system of attention in individuals with persistent attention deficits related to mTBI +/- PTSD.

Official Title

Neuromodulation and Neurorehabilitation for Treatment of Functional Deficits After mTBI and PTSD

Quick Facts

Study Start:2021-04-01
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03819608

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 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * At least 18 years of age and no older than 80 years of age
  2. * 3 months post exposure to mTBI event
  3. * Have a history of mTBI with PTSD OR mTBI without PTSD as defined by formalized measures to classify mTBI based on the Symptom Attribution and Classification Algorithm (SACA) and the PTSD Module L of the SCID
  4. * Endorse at least moderate severity on at least one of the four cognitive complaints in the Neurobehavioral Symptom Inventory
  1. * Participating in another research study
  2. * Non-fluent in English (speaking and reading)
  3. * History of epilepsy pre-injury
  4. * Receiving antiepileptic treatment for documented active seizures in the past 6 months
  5. * Taking medications that lower seizure threshold including antipsychotics, trazodone and tramadol
  6. * History of surgery on blood vessels in brain and/or valves of the heart
  7. * History of brain hemorrhage, neurovascular conditions and neurodegenerative disorders
  8. * History or current diagnosis of psychotic spectrum disorders (i.e. bipolar, schizophrenia)
  9. * Significant heart disease as determined by physician review of medical chart
  10. * Pregnant at time of enrollment or any time during study participation
  11. * MRI or TMS/iTBS contraindications such as claustrophobia, metal in eyes/face or brain
  12. * Cardiac pacemakers/defibrillators, cochlear implants, nerve stimulators, intracranial metal clips
  13. * Diagnosis of moderate or severe TBI (loss of consciousness \> 30 minutes, alteration of consciousness \> 24 hours, post traumatic amnesia or neuropsychological testing results
  14. * Prescribed dosage of mental health medications have been altered within the month preceding study screening. Any participant whose mental health medication(s) has/have changed, within 30 days of study screening. The following are considered a medication change: the addition of or discontinuation of medication, a change in the dose or dosage (daily amount) of medication.
  15. * Taking prescribed CNS stimulants and choosing to not stop these medications during study participation
  16. * Taking prescribed CNS stimulants and choosing to not stop these medications during study participation
  17. * Testing positive for opiates and do not have a prescription for opiates. If on prescription opiates and taking more than the equivalent of 200 mg of morphine per day.
  18. * Questionably valid test performance as indicated by a score of ≤ 85% on the Immediate Recognition, Delayed Recognition or Consistency Scales of the Medical Symptom Validity Test (MSVT) and clinical determination of questionable performance validity by a neuropsychologist on the research team
  19. * Actively suicidal as evidenced by plan to harm or recent attempt communicated on the Structured Clinical Interview for DSM-V (SCID-5).
  20. * Increased Intracranial Pressure (ICP) as evidenced through a funduscopic evaluation or on the baseline MRI scan.
  21. * Moderate or severe cannabis use disorder defined by ≥ 4 symptoms on the SCID-5
  22. * Severe alcohol use disorder defined by ≥ 6 symptoms on the SCID-5
  23. * Baseline systolic BP greater or equal to 170

Contacts and Locations

Study Contact

Catherine M Kestner
CONTACT
708-878-0578
ckestner@sralab.org

Principal Investigator

Theresa LB Pape, Dr.PH
PRINCIPAL_INVESTIGATOR
Northwestern University

Study Locations (Sites)

Northwestern University
Chicago, Illinois, 60141
United States
Moody Neurorehabilitation Institute
Houston, Texas, 77058
United States

Collaborators and Investigators

Sponsor: Northwestern University

  • Theresa LB Pape, Dr.PH, PRINCIPAL_INVESTIGATOR, Northwestern University

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 Date2021-04-01
Study Completion Date2025-12

Study Record Updates

Study Start Date2021-04-01
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • mTBI
  • PTSD
  • intermittent theta burst stimulation
  • cognitive training
  • neuroimaging

Additional Relevant MeSH Terms

  • Mild Traumatic Brain Injury
  • Post Traumatic Stress Disorder