Brain Stimulation for Mild Traumatic Brain Injury (tDCS/PPCS)
Primary Purpose
Traumatic Brain Injury, Post-Concussion Symptoms
Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Frontal Stimulation
Temporal Stimulation
Sham Stimulation
Sponsored by
About this trial
This is an interventional other trial for Traumatic Brain Injury focused on measuring Traumatic Brain Injury, Post concussion syndrome, Transcranial Direct Current Stimulation, Neuromodulation
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
Sites / Locations
- HC University of Sao Paulo - Medical SchoolRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Frontal Stimulation
Temporal Stimulation
Sham Stimulation
Arm Description
Left dorsolateral prefrontal cortex stimulation
Left temporal cortex stimulation
Sham stimulation
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02292589
First Posted
November 12, 2014
Last Updated
May 7, 2019
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02292589
Brief Title
Brain Stimulation for Mild Traumatic Brain Injury
Acronym
tDCS/PPCS
Official Title
tDCS in Patients With Mild Traumatic Brain Injury and Persistent Post Concussion Syndrome: Randomized Crossover Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
April 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Post-Concussion Symptoms
Keywords
Traumatic Brain Injury, Post concussion syndrome, Transcranial Direct Current Stimulation, Neuromodulation
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Frontal Stimulation
Arm Type
Experimental
Arm Description
Left dorsolateral prefrontal cortex stimulation
Arm Title
Temporal Stimulation
Arm Type
Experimental
Arm Description
Left temporal cortex stimulation
Arm Title
Sham Stimulation
Arm Type
Experimental
Arm Description
Sham stimulation
Intervention Type
Device
Intervention Name(s)
Frontal Stimulation
Intervention Description
The patient will receive anodal tDCS on left dorsolateral prefrontal cortex with an intensity of 1.5 mA for 20 minutes.
Intervention Type
Device
Intervention Name(s)
Temporal Stimulation
Intervention Description
The patient will receive anodal tDCS on left temporal cortex with an intensity of 1.5 mA for 20 minutes.
Intervention Type
Device
Intervention Name(s)
Sham Stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evidence of improvement of patient's episodic memory and executive function measured by neuropsychological test
Description
HVLT, Wechsler memory scale, Inhibitory control test(ICT) and Block-tapping test.
Time Frame
immediately after the stimulation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robson L Amorim, MD, PhD
Phone
+55 11 991344180
Email
amorimrl@usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Andre R Brunoni, MD, PhD
Phone
+55 11 2671-8159
Email
EMT.ipq@hc.fm.usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robson L Amorim, MD
Organizational Affiliation
University of Sao Paulo Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
HC University of Sao Paulo - Medical School
City
São Paulo
State/Province
SP
ZIP/Postal Code
05410-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robson L Amorim, MD
Phone
+55 11 991344180
Email
amorimrl@usp.br
12. IPD Sharing Statement
Citations:
PubMed Identifier
23756431
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.
Results Reference
background
PubMed Identifier
15753425
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.
Results Reference
background
PubMed Identifier
15193031
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.
Results Reference
background
PubMed Identifier
17222319
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.
Results Reference
background
PubMed Identifier
19934558
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.
Results Reference
background
PubMed Identifier
8736107
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.
Results Reference
background
PubMed Identifier
14519601
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.
Results Reference
background
PubMed Identifier
21346569
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.
Results Reference
background
PubMed Identifier
15545210
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.
Results Reference
background
PubMed Identifier
28512443
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.
Results Reference
derived
Learn more about this trial
Brain Stimulation for Mild Traumatic Brain Injury
We'll reach out to this number within 24 hrs