Brain Stimulation for Traumatic Brain Injury

Study Overview
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Brief Summary
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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).

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

Conditions
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Traumatic Brain Injury, Diffuse Axonal Injury

Intervention / Treatment
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* Other: Active Coil
* Other: Sham


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Coil<br>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<br>* 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.<br>|
| Sham Comparator: Sham<br>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<br>* The patients assigned to this group will undergo 10 sessions of rTMS but with an inactive coil, which will not generate electromagnetic pulses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 
| Changes in cortical excitability measured by single and paired-pulse TMS |  | one week and three months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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traumatic brain injury, diffuse axonal injury, repetitive transcranial magnetic stimulation, neuromodulation, cognitive rehabilitation