Neuromodulation and Neurorehabilitation for mTBI (NCT03819608) | Clinical Trial Compass
RecruitingNot Applicable
Neuromodulation and Neurorehabilitation for mTBI
United States200 participantsStarted 2021-04-01
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, …
What they're measuring
1
Change in the Mayo Portland Adaptability Inventory (MPAI)