Clinical trial NCT03819608: Neuromodulation and Neurorehabilitation for mTBI
Official title: Neuromodulation and Neurorehabilitation for Treatment of Functional Deficits After mTBI and PTSD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Traumatic Brain Injury
Post Traumatic Stress Disorder
Keywords: mTBI
PTSD
intermittent theta burst stimulation
cognitive training
neuroimaging
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2019-01-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age and no older than 80 years of age
* 3 months post exposure to mTBI event
* 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
* Endorse at least moderate severity on at least one of the four cognitive complaints in the Neurobehavioral Symptom Inventory

Exclusion Criteria:

* Participating in another research study
* Non-fluent in English (speaking and reading)
* History of epilepsy pre-injury
* Receiving antiepileptic treatment for documented active seizures in the past 6 months
* Taking medications that lower seizure threshold including antipsychotics, trazodone and tramadol
* History of surgery on blood vessels in brain and/or valves of the heart
* History of brain hemorrhage, neurovascular conditions and neurodegenerative disorders
* History or current diagnosis of psychotic spectrum disorders (i.e. bipolar, schizophrenia)
* Significant heart disease as determined by physician review of medical chart
* Pregnant at time of enrollment or any time during study participation
* MRI or TMS/iTBS contraindications such as claustrophobia, metal in eyes/face or brain
* Cardiac pacemakers/defibrillators, cochlear implants, nerve stimulators, intracranial metal clips
* Diagnosis of moderate or severe TBI (loss of consciousness \> 30 minutes, alteration of consciousness \> 24 hours, post traumatic amnesia or neuropsychological testing results
* 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.
* Taking prescribed CNS stimulants and choosing to not stop these medications during study participation
* Taking prescribed CNS stimulants and choosing to not stop these medications during study participation
* 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.
* 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
* Actively suicidal as evidenced by plan to harm or recent attempt communicated on the Structured Clinical Interview for DSM-V (SCID-5).
* Increased Intracranial Pressure (ICP) as evidenced through a funduscopic evaluation or on the baseline MRI scan.
* Moderate or severe cannabis use disorder defined by ≥ 4 symptoms on the SCID-5
* Severe alcohol use disorder defined by ≥ 6 symptoms on the SCID-5
* Baseline systolic BP greater or equal to 170

Primary outcomes:
measure: Change in the Mayo Portland Adaptability Inventory (MPAI)
timeFrame: baseline, 5 weeks, 10 weeks, 20 weeks
Secondary outcomes:
measure: change in the PTSD Checklist (PCL)
timeFrame: baseline, 5 weeks, 10 weeks, 20 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Houston
country: United States
facility: Moody Neurorehabilitation Institute
state: Texas
Study officials:
affiliation: Northwestern University
name: Theresa LB Pape, Dr.PH
role: PRINCIPAL_INVESTIGATOR
References: