Neuromodulation and Neurorehabilitation for mTBI

Launched by NORTHWESTERN UNIVERSITY · Jan 25, 2019

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for individuals who have experienced a mild traumatic brain injury (mTBI) and may also have post-traumatic stress disorder (PTSD). The study aims to see how well a combination of interactive computer training, which helps improve attention, works together with a specific type of brain stimulation called intermittent theta burst stimulation (iTBS). Researchers want to find out how this combination can improve attention and cognitive function in people who are still struggling with these issues after their injury.

To participate in this trial, you must be between 18 and 80 years old, have had a mild traumatic brain injury at least three months ago, and experience attention difficulties. You should also have a diagnosis of PTSD or have had an mTBI without PTSD. Participants can expect to engage in training sessions and possibly receive the brain stimulation treatment, all while being monitored by health professionals. However, there are several reasons why someone might not be eligible, such as having certain medical conditions or taking specific medications. If you or a loved one meets the eligibility criteria and is interested in participating, this study could offer new insights and potential benefits for managing the effects of mTBI and PTSD.

Gender

ALL

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