A Phase 2 interventional study of Active Coil and Sham in Traumatic Brain Injury and Diffuse Axonal Injury, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-08-15.
Sponsored by University of Sao Paulo · Phase 2, Interventional, and Treatment
The purpose of this study is to determine whether repetitive Transcranial Magnetic Stimulation (rTMS) is effective in the cognitive rehabilitation of patients with diffuse axonal injury(DAI) after Traumatic Brain Injury(TBI).
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's enrollment of 30 is below the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
The patients assigned to this group will undergo repetitive Transcranial Magnetic Stimulation over 10 sessions (each one with 2,000 pulses) on left dorsolateral prefrontal cortex.
Other: Active Coil
The patients assigned to this group will undergo 10 sessions of rTMS but with an inactive coil, which will not generate electromagnetic pulses.
Other: Sham
The patients will undergo 10 sessions (2,000 pulses each, lasting 20 minutes) of repetitive transcranial magnetic stimulation over the left dorsolateral prefrontal cortex with the following parameters: 10Hz, 50 trains (40 pulses on each train), biphasic wave, 25 seconds between the trains.
The patients assigned to this group will undergo 10 sessions of rTMS but with an inactive coil, which will not generate electromagnetic pulses.
Evidence of improvement on Attentional processes measured by cognitive evaluation (Trail Making Test parts A and B; Stroop Test - Victoria Version; Symbol Digit Test)
Time frame: One week and three months after rTMS.
Evidence of improvement on Executive Function processes measured by cognitive evaluation.
Time frame: one week and 3 months.
Evidence of improvement on Motor Coordination measured by cognitive evaluation.
Time frame: one week and three months.
Changes in cortical excitability measured by single and paired-pulse TMS
Time frame: one week and three months.
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo