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NCT Number: NCT03819608

Neuromodulation and Neurorehabilitation for mTBI

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University, Chicago, Illinois, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Real iTBS

Device

Intermittent Theta Burst Stimulation (iTBS) is a form of repetitive transcranial magnetic stimulation (rTMS), which uses short magnetic field pulses applied to the scalp to induce currents in the underlying brain. iTBS will be delivered with the Magventure MagProX100 with MagOption stimulator and Magpro Cool Coil B65 A/P. The Magpro Cool Coil B65 A/P can be switched to active or placebo (A/P).

Other names: intermittent Theta Burst Stimulation

real APT

Behavioral

APT-III is an attention processing training program

Other names: Attention Processing Training-III

placebo APT

Behavioral

computerized cognitive training

Other names: Active Control APT

placebo iTBS

Device

delivered with the Magventure MagProX100 with MagOption stimulator and Magpro Cool Coil B65 A/P. The Magpro Cool Coil B65 A/P can be switched to active or placebo (A/P).

Other names: sham intermittent Theta Burst Stimulation

Primary outcomes

  1. Change in the Mayo Portland Adaptability Inventory (MPAI)

    Time frame: baseline, 5 weeks, 10 weeks, 20 weeks

    Self-reported ability, adjustment and community participation. It is comprised of 30 items and three subscales: Ability Index, Adjustment Index and Participation Index. Items are scored on a 5-point Likert scale, with lower scores indicating higher levels of functioning.

Secondary outcomes

  1. change in the PTSD Checklist (PCL)

    Time frame: baseline, 5 weeks, 10 weeks, 20 weeks

    20-item self-report measure assessing the distress associated with PTSD symptoms. The higher the score, the worse the symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Catherine M Kestner

CONTACT

[email protected]

708-878-0578

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 28, 2019
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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