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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Coil | Experimental | 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. |
|
| Sham | Sham Comparator | The patients assigned to this group will undergo 10 sessions of rTMS but with an inactive coil, which will not generate electromagnetic pulses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Coil | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Evidence of improvement on Attentional processes measured by cognitive evaluation (Trail Making Test parts A and B; Stroop Test - Victoria Version; Symbol Digit Test) | One week and three months after rTMS. |
| Measure | Description | Time Frame |
|---|---|---|
| Evidence of improvement on Executive Function processes measured by cognitive evaluation. | one week and 3 months. | |
| Evidence of improvement on Motor Coordination measured by cognitive evaluation. | one week and three months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wellingson S Paiva, MD | University of Sao Paulo | Study Chair |
| Iuri N Ribeiro, MD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinics Hospital - University of Sao Paulo Medical School | São Paulo | São Paulo | 054010-000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33343483 | Derived | Rodrigues PA, Zaninotto AL, Ventresca HM, Neville IS, Hayashi CY, Brunoni AR, de Paula Guirado VM, Teixeira MJ, Paiva WS. The Effects of Repetitive Transcranial Magnetic Stimulation on Anxiety in Patients With Moderate to Severe Traumatic Brain Injury: A Post-hoc Analysis of a Randomized Clinical Trial. Front Neurol. 2020 Dec 4;11:564940. doi: 10.3389/fneur.2020.564940. eCollection 2020. | |
| 31175209 |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D020833 | Diffuse Axonal Injury |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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|
| Sham | Other | The patients assigned to this group will undergo 10 sessions of rTMS but with an inactive coil, which will not generate electromagnetic pulses. |
|
| Changes in cortical excitability measured by single and paired-pulse TMS | one week and three months. |
| Derived |
| Neville IS, Zaninotto AL, Hayashi CY, Rodrigues PA, Galhardoni R, Ciampi de Andrade D, Brunoni AR, Amorim RLO, Teixeira MJ, Paiva WS. Repetitive TMS does not improve cognition in patients with TBI: A randomized double-blind trial. Neurology. 2019 Jul 9;93(2):e190-e199. doi: 10.1212/WNL.0000000000007748. Epub 2019 Jun 7. |
| 26438108 | Derived | Neville IS, Hayashi CY, El Hajj SA, Zaninotto AL, Sabino JP, Sousa LM Jr, Nagumo MM, Brunoni AR, Shieh BD, Amorim RL, Teixeira MJ, Paiva WS. Repetitive Transcranial Magnetic Stimulation (rTMS) for the cognitive rehabilitation of traumatic brain injury (TBI) victims: study protocol for a randomized controlled trial. Trials. 2015 Oct 5;16:440. doi: 10.1186/s13063-015-0944-2. |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D000070625 | Brain Injuries, Diffuse |