Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT03819608

Neuromodulation and Neurorehabilitation for mTBI

Led by Northwestern University · Updated on 2026-05-08

200

Participants Needed

2

Research Sites

295 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Neuromodulation and Neurorehabilitation for mTBI

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years of age and no older than 80 years of age
  • At least 3 months after experiencing a mild traumatic brain injury (mTBI) event
  • History of mTBI with or without post-traumatic stress disorder (PTSD) confirmed by formal measures
  • Report at least moderate severity on one or more cognitive complaints in the Neurobehavioral Symptom Inventory
Not Eligible

You will not qualify if you...

  • Currently participating in another research study
  • Not fluent in English (speaking and reading)
  • History of epilepsy before injury
  • Receiving antiepileptic treatment for active seizures within the past 6 months
  • Taking medications that lower seizure threshold, including antipsychotics, trazodone, and tramadol
  • History of brain blood vessel surgery or heart valve surgery
  • History of brain hemorrhage, neurovascular conditions, or neurodegenerative disorders
  • Diagnosis or history of psychotic spectrum disorders (e.g., bipolar disorder, schizophrenia)
  • Significant heart disease based on physician review
  • Pregnant at enrollment or during study participation
  • Contraindications for MRI or TMS/iTBS such as claustrophobia or metal in eyes, face, or brain
  • Presence of cardiac pacemakers, defibrillators, cochlear implants, nerve stimulators, or intracranial metal clips
  • Diagnosis of moderate or severe traumatic brain injury
  • Mental health medication dosage changed within 30 days before screening
  • Taking prescribed CNS stimulants and not willing to stop during study
  • Positive test for opiates without prescription or high dose prescription opiates
  • Poor test performance indicating questionable validity
  • Active suicidal thoughts or recent attempts
  • Increased intracranial pressure
  • Moderate or severe cannabis use disorder
  • Severe alcohol use disorder
  • Baseline systolic blood pressure 170 or higher

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Northwestern University

Chicago, Illinois, United States, 60141

Actively Recruiting

2

Moody Neurorehabilitation Institute

Houston, Texas, United States, 77058

Actively Recruiting

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Research Team

C

Catherine M Kestner

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

4

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