Brain Stimulation for Mild Traumatic Brain Injury

Study Overview
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Brief Summary
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The purpose of this study is to determine the early effects of transcranial direct current stimulation (tDCS) in patients with mild traumatic brain injury and persistent post concussion syndrome(PPCS) with cognitive deficits in long term episodic memory and executive function(inhibitory control).

Detailed Description
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This is a randomized crossover trial of patients with mild TBI (mTBI) sustaining PPCS. It will be recruited twenty adult patients who will receive three sessions of anodal tDCS: left dorsolateral prefrontal cortex, left temporal cortex(with an intensity of 1.5 mA for 20 min) and sham stimulation(intensity of 1.5 mA for 30 seconds only). Sessions will be performed with at least 7 days of interval(wash out period) in a randomized order. Patients who meet the inclusion criteria will be assessed with a neuropsychological evaluation - battery tests include Beck Depression Scale, Hopkins Verbal Learning(HVLT), Stroop test and digit, letters and numbers sequence. A new battery of computerized neuropsychological test will be performed before and immediately after each stimulation(HVLT, Wechsler memory scale, Inhibitory control test(ICT) and block-tapping test.

Official Title
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tDCS in Patients With Mild Traumatic Brain Injury and Persistent Post Concussion Syndrome: Randomized Crossover Trial

Conditions
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Traumatic Brain Injury, Post-Concussion Symptoms

Intervention / Treatment
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* Device: Frontal Stimulation
* Device: Temporal Stimulation
* Device: Sham Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: history of mild traumatic brain injury on hospital admission subjective complain of memory and executive function must be able to sign the Informed Consent Form Exclusion Criteria: under or over age limits no specific complain of memory and executive function history of major depression(Beck Inventory>35) drug addiction uncontrolled epilepsy presence of any metallic prosthesis implant presence of cochlear implant not able to sign the Informed Consent Form

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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Frontal Stimulation<br>Left dorsolateral prefrontal cortex stimulation | Device: Frontal Stimulation<br>* The patient will receive anodal tDCS on left dorsolateral prefrontal cortex with an intensity of 1.5 mA for 20 minutes.<br>|
| Experimental: Temporal Stimulation<br>Left temporal cortex stimulation | Device: Temporal Stimulation<br>* The patient will receive anodal tDCS on left temporal cortex with an intensity of 1.5 mA for 20 minutes.<br>|
| Experimental: Sham Stimulation<br>Sham stimulation | Device: Sham Stimulation<br>* The patient will receive anodal tDCS over the occipital area for 30 seconds only and then it will be turned off without the patient's knowledge.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of improvement of patient's episodic memory and executive function measured by neuropsychological test | HVLT, Wechsler memory scale, Inhibitory control test(ICT) and Block-tapping test. | immediately after the stimulation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traumatic Brain Injury, Post concussion syndrome, Transcranial Direct Current Stimulation, Neuromodulation