RecruitingNot ApplicableNCT03819608

Neuromodulation and Neurorehabilitation for mTBI

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

Sponsor

Northwestern University

Enrollment

200 participants

Start Date

Apr 1, 2021

Study Type

INTERVENTIONAL

Conditions

Post Traumatic Stress Disorder Mild Traumatic Brain Injury

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing brain stimulation and rehabilitation techniques (called neuromodulation and neurorehabilitation — non-invasive methods that gently stimulate specific brain areas) to help people recover from mild traumatic brain injury (mTBI, commonly known as concussion), with or without post-traumatic stress disorder (PTSD). **You may be eligible if...** - You are between 18 and 80 years old - You experienced a mild traumatic brain injury (concussion) at least 3 months ago - You have cognitive complaints (such as trouble concentrating or remembering) rated as at least moderate - You have been formally assessed for mTBI and may also have PTSD **You may NOT be eligible if...** - You are already participating in another research study - You are not fluent in English - You had epilepsy before your injury - You have had active seizures in the past 6 months or take anti-seizure medication - You take medications that lower the seizure threshold (such as antipsychotics or trazodone) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEreal iTBS

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).

BEHAVIORALreal APT

APT-III is an attention processing training program

BEHAVIORALplacebo APT

computerized cognitive training

DEVICEplacebo iTBS

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).

Locations(2)

Northwestern University

Chicago, Illinois, United States

Moody Neurorehabilitation Institute

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT03819608

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