Neuromodulation and Neurorehabilitation for mTBI
Key facts
- Who runs it
- Northwestern University
- Where
- Chicago and Houston, United StatesSee the 2 sites
- Trial code
- Status
- Recruiting
- People taking part
- 200 people, planned
- Started
- 1 Apr 2021
- Expected to end
- Dec 2027
- Type of study
- Interventional, 4 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- real iTBS
- real APT
- placebo APT
- placebo iTBS
- Record updated
- 16 October 2026
Who can take part
- Age
- 18 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 27 criteriaShow less
Who can take part
- 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
Who cannot take part
- Receiving antiepileptic treatment for documented active seizures in the past 6 months
- 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
- History of epilepsy pre-injury
- 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
- Cardiac pacemakers/defibrillators, cochlear implants, nerve stimulators, intracranial metal clips
- 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
- Participating in another research study
- Non-fluent in English (speaking and reading)
- 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
- Diagnosis of moderate or severe TBI (loss of consciousness > 30 minutes, alteration of consciousness > 24 hours, post traumatic amnesia or neuropsychological testing results
- 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
- Baseline systolic BP greater or equal to 170
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in United States
- Northwestern UniversityChicago, United StatesContact: Katie Kestner, PTTaking people
- Moody Neurorehabilitation InstituteHouston, United StatesContact: Catherine M KestnerNo longer taking part
About the trial
What the trial wants to find out
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.
The 4 groups in the trial
- real APT+ real iTBSTreatment being tested
real APT+ real iTBS included 30 1-hour treatment sessions will be provided 3/week. Sessions will be conducted for 10 weeks. APT-III is a computer based cognitive training program. iTMS will be applied at 5Hz rate; each burst consists of 3 pulses delivered at 50Hz rate. The bursts are applied for 2s with 8s inter-burst-intervals, for a total of 600 pulses. The total stimulation time per session is approximately 192s (\~ 3 minutes). Participants randomized to active iTBS will receive stimulation at the right dorsolateral prefrontal cortex at 80% active motor threshold .
Treatment: real iTBS and real APT
- real APT + placebo iTBSExisting treatment, for comparison
30 1-hour treatment sessions will be provided 3/week. Sessions will be conducted for 10 weeks. APT-III is a computer based cognitive training program. Participants randomized to placebo iTBS will not receive any iTBS stimulation.
Treatment: real APT and placebo iTBS
- placebo APT+ real iTBSExisting treatment, for comparison
30 1-hour treatment sessions will be provided 3/week. Sessions will be conducted for 10 weeks. Placebo APT-III is a computer based active control cognitive training program. Bursts of TMS pulses will be applied at 5Hz rate; each burst consists of 3 pulses delivered at 50Hz rate. The bursts are applied for 2s with 8s inter-burst-intervals, for a total of 600 pulses. The total stimulation time per session is approximately 192s (\~ 3 minutes). Participants randomized to active iTBS will receive stimulation at the right DLPFC at 80% active motor threshold .
Treatment: real iTBS and placebo APT
- placebo APT+ placebo iTBSExisting treatment, for comparison
30 1-hour treatment sessions will be provided 3/week. Sessions will be conducted for 10 weeks. Placebo APT-III is a computer based active control cognitive training program. Participants randomized to placebo iTBS will not receive any iTBS stimulation.
Treatment: placebo APT and placebo iTBS
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Neuromodulation and Neurorehabilitation for Treatment of Functional Deficits After mTBI and PTSD
- Fit questions
- Built from NCT03819608, who can take part
- Record updated
- 16 October 2026