Sign in
Taking people in United StatesNo phase

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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data 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