Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: real iTBS for Mild Traumatic Brain Injury

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.

Official registry: https://clinicaltrials.gov/study/NCT03819608 · Northwestern University · enrollment listed as 200

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are real iTBS, real APT, or placebo APT. The registry lists allocation as randomized. 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.

They plan to enroll about 200 people at 2 sites. Taking part typically means using or being fitted with a device, following a program (exercise, therapy, diet, or an app) plus check-ins.

Official title (unrewritten)

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

Interventions: real iTBS, real APT, placebo APT, placebo iTBS

Primary outcome (registry wording): Change in the Mayo Portland Adaptability Inventory (MPAI)

Who it is for (from inclusion criteria)

  • Ages 18 Years to 80 Years
  • 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

Public study contact (from the registry)

Catherine M Kestner

708-878-0578

ckestner@sralab.org

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

2 listed

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FAQ about this NCT record

Is NCT03819608 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT03819608?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT03819608?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary