Brain Stimulation for Mild Traumatic Brain Injury

NCT ID: NCT02292589

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2028-04-30

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.

Conditions

Traumatic Brain Injury; Post-Concussion Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Frontal Stimulation

Left dorsolateral prefrontal cortex stimulation

Group Type: EXPERIMENTAL

Frontal Stimulation

Intervention Type: DEVICE

The patient will receive anodal tDCS on left dorsolateral prefrontal cortex with an intensity of 1.5 mA for 20 minutes.

Temporal Stimulation

Left temporal cortex stimulation

Group Type: EXPERIMENTAL

Temporal Stimulation

Intervention Type: DEVICE

The patient will receive anodal tDCS on left temporal cortex with an intensity of 1.5 mA for 20 minutes.

Sham Stimulation

Sham stimulation

Group Type: EXPERIMENTAL

Sham Stimulation

Intervention Type: DEVICE

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.

Interventions

Frontal Stimulation

The patient will receive anodal tDCS on left dorsolateral prefrontal cortex with an intensity of 1.5 mA for 20 minutes.

Intervention Type: DEVICE

Temporal Stimulation

The patient will receive anodal tDCS on left temporal cortex with an intensity of 1.5 mA for 20 minutes.

Intervention Type: DEVICE

Sham Stimulation

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robson L Amorim, MD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo Medical School

Locations

HC University of Sao Paulo - Medical School

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: BACKGROUND

PMID: 23756431 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15753425 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15193031 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17222319 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19934558 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8736107 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14519601 (View on PubMed)

Prigatano GP, Gale SD. The current status of postconcussion syndrome. Curr Opin Psychiatry. 2011 May;24(3):243-50. doi: 10.1097/YCO.0b013e328344698b.

Reference Type: BACKGROUND

PMID: 21346569 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15545210 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28512443 (View on PubMed)

Other Identifiers

RAHC-001

Identifier Type: -

Identifier Source: org_study_id