Clinical trial NCT02167971: Brain Stimulation for Traumatic Brain Injury
Official title: Evaluation of Repetitive Transcranial Magnetic Stimulation on the Cognitive Rehabilitation After Traumatic Diffuse Axonal Injury.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Traumatic Brain Injury
Diffuse Axonal Injury
Keywords: traumatic brain injury
diffuse axonal injury
repetitive transcranial magnetic stimulation
neuromodulation
cognitive rehabilitation
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2014-06-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* Clinical and radiological diagnosis of traumatic brain injury.
* Between one to two years after traumatic brain injuri
* Must be able to sign the Informed Consent Form

Exclusion Criteria:

* Drug addiction
* Uncontrolled epilepsy
* Extensive Cranial vault defects

Primary outcomes:
measure: Evidence of improvement on Attentional processes measured by cognitive evaluation (Trail Making Test parts A and B; Stroop Test - Victoria Version; Symbol Digit Test)
timeFrame: One week and three months after rTMS.
Secondary outcomes:
measure: Evidence of improvement on Executive Function processes measured by cognitive evaluation.
timeFrame: one week and 3 months.
measure: Evidence of improvement on Motor Coordination measured by cognitive evaluation.
timeFrame: one week and three months.
measure: Changes in cortical excitability measured by single and paired-pulse TMS
timeFrame: one week and three months.
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Clinics Hospital - University of Sao Paulo Medical School
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Wellingson S Paiva, MD
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Iuri N Ribeiro, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.