Clinical Trial: Brain Stimulation for Mild Traumatic Brain Injury

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: 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 Summary: 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.
Sponsor: University of Sao Paulo General Hospital

Current Primary Outcome: Evidence of improvement of patient's episodic memory and executive function measured by neuropsychological test [ Time Frame: immediately after the stimulation ]

HVLT, Wechsler memory scale, Inhibitory control test(ICT) and Block-tapping test.


Original Primary Outcome: Evidence of improvement of patient's episodic memory and executive function measured by neuropsychocological test [ Time Frame: immediately after the stimulation ]

HVLT, Wechsler memory scale, Inhibitory control test(ICT) and Block-tapping test.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Sao Paulo General Hospital

Dates:
Date Received: November 12, 2014
Date Started: October 2014
Date Completion: April 2018
Last Updated: May 15, 2017
Last Verified: April 2017