Brain Stimulation for Traumatic Brain Injury

Phase 2

Completed

• Conditions: Traumatic Brain Injury; Diffuse Axonal Injury
• Interventions: Other: Active Coil; Other: Sham

• Registration Number: NCT02167971
• Lead Sponsor: University of Sao Paulo

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-06-17
• Study First Submitted QC: 2014-06-17
• Study First Posted: 2014-06-19
• Status Verified: 2017-08
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Last Update Submitted: 2017-08-11
• Last Update Posted: 2017-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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Exclusion Criteria

• Drug addiction
• Uncontrolled epilepsy
• Extensive Cranial vault defects

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Coil	Active Coil	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	The patients assigned to this group will undergo 10 sessions of rTMS but with an inactive coil, which will not generate electromagnetic pulses.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Clinics Hospital - University of Sao Paulo Medical School; 🇧🇷 Sao Paulo, SP, Brazil