Clinical trial NCT02292589: Brain Stimulation for Mild Traumatic Brain Injury
Official title: tDCS in Patients With Mild Traumatic Brain Injury and Persistent Post Concussion Syndrome: Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Traumatic Brain Injury
Post-Concussion Symptoms
Keywords: Traumatic Brain Injury
Post concussion syndrome
Transcranial Direct Current Stimulation
Neuromodulation
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2014-11-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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 description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evidence of improvement of patient's episodic memory and executive function measured by neuropsychological test
timeFrame: immediately after the stimulation
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: HC University of Sao Paulo - Medical School
state: SP
Study officials:
affiliation: University of Sao Paulo Medical School
name: Robson L Amorim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lesniak M, Polanowska K, Seniow J, Czlonkowska A. Effects of repeated anodal tDCS coupled with cognitive training for patients with severe traumatic brain injury: a pilot randomized controlled trial. J Head Trauma Rehabil. 2014 May-Jun;29(3):E20-9. doi: 10.1097/HTR.0b013e318292a4c2.
citation: Iyer MB, Mattu U, Grafman J, Lomarev M, Sato S, Wassermann EM. Safety and cognitive effect of frontal DC brain polarization in healthy individuals. Neurology. 2005 Mar 8;64(5):872-5. doi: 10.1212/01.WNL.0000152986.07469.E9.
citation: McArthur DL, Chute DJ, Villablanca JP. Moderate and severe traumatic brain injury: epidemiologic, imaging and neuropathologic perspectives. Brain Pathol. 2004 Apr;14(2):185-94. doi: 10.1111/j.1750-3639.2004.tb00052.x.
citation: Bajaj JS, Saeian K, Verber MD, Hischke D, Hoffmann RG, Franco J, Varma RR, Rao SM. Inhibitory control test is a simple method to diagnose minimal hepatic encephalopathy and predict development of overt hepatic encephalopathy. Am J Gastroenterol. 2007 Apr;102(4):754-60. doi: 10.1111/j.1572-0241.2007.01048.x. Epub 2007 Jan 11.
citation: Datta SG, Pillai SV, Rao SL, Kovoor JM, Chandramouli BA. Post-concussion syndrome: Correlation of neuropsychological deficits, structural lesions on magnetic resonance imaging and symptoms. Neurol India. 2009 Sep-Oct;57(5):594-8. doi: 10.4103/0028-3886.57810.
citation: Gorenstein C, Andrade L. Validation of a Portuguese version of the Beck Depression Inventory and the State-Trait Anxiety Inventory in Brazilian subjects. Braz J Med Biol Res. 1996 Apr;29(4):453-7.
citation: King NS. Post-concussion syndrome: clarity amid the controversy? Br J Psychiatry. 2003 Oct;183:276-8. doi: 10.1192/bjp.183.4.276. No abstract available.
citation: Prigatano GP, Gale SD. The current status of postconcussion syndrome. Curr Opin Psychiatry. 2011 May;24(3):243-50. doi: 10.1097/YCO.0b013e328344698b.
citation: Wood RL. Understanding the 'miserable minority': a diasthesis-stress paradigm for post-concussional syndrome. Brain Inj. 2004 Nov;18(11):1135-53. doi: 10.1080/02699050410001675906.
citation: de Amorim RLO, Brunoni AR, de Oliveira MAF, Zaninotto ALC, Nagumo MM, Guirado VMP, Neville IS, Benute GRG, de Lucia MCS, Paiva WS, de Andrade AF, Teixeira MJ. Transcranial Direct Current Stimulation for Post-Concussion Syndrome: Study Protocol for a Randomized Crossover Trial. Front Neurol. 2017 May 2;8:164. doi: 10.3389/fneur.2017.00164. eCollection 2017.