NCT03819608

Neuromodulation and Neurorehabilitation for mTBI

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mild Traumatic Brain Injury
• Post Traumatic Stress Disorder

Interventions

Type	Name	Description
DEVICE	real 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).
BEHAVIORAL	real APT	APT-III is an attention processing training program
BEHAVIORAL	placebo APT	computerized cognitive training
DEVICE	placebo 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).

Timeline

• Start date: 2021-04-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2019-01-28
• Last updated: 2025-04-02

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study