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Clinical Trials/NCT02167971
NCT02167971
Completed
Phase 2

Evaluation of Repetitive Transcranial Magnetic Stimulation on the Cognitive Rehabilitation After Traumatic Diffuse Axonal Injury.

University of Sao Paulo1 site in 1 country30 target enrollmentJanuary 2014

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Traumatic Brain Injury
Sponsor
University of Sao Paulo
Enrollment
30
Locations
1
Primary Endpoint
Evidence of improvement on Attentional processes measured by cognitive evaluation (Trail Making Test parts A and B; Stroop Test - Victoria Version; Symbol Digit Test)
Status
Completed
Last Updated
8 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
August 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Iuri Santana Neville Ribeiro

iurineville

University of Sao Paulo

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Changes in cortical excitability measured by single and paired-pulse TMS(one week and three months.)
  • 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.)

Study Sites (1)

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