NCT02292589

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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
23mo left

Started Oct 2014

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Oct 2014Apr 2028

Study Start

First participant enrolled

October 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 12, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 17, 2014

Completed
11.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Expected
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

11.3 years

First QC Date

November 12, 2014

Last Update Submit

January 29, 2024

Conditions

Traumatic Brain InjuryPost-Concussion Symptoms

Keywords

Traumatic Brain InjuryPost concussion syndromeTranscranial Direct Current StimulationNeuromodulation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Frontal Stimulation

EXPERIMENTAL

Left dorsolateral prefrontal cortex stimulation

Device: Frontal Stimulation

Temporal Stimulation

EXPERIMENTAL

Left temporal cortex stimulation

Device: Temporal Stimulation

Sham Stimulation

EXPERIMENTAL

Sham stimulation

Device: Sham Stimulation

Interventions

Frontal StimulationDEVICE

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

Frontal Stimulation
Temporal StimulationDEVICE

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

Temporal Stimulation
Sham StimulationDEVICE

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.

Sham Stimulation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HC University of Sao Paulo - Medical School

São Paulo, São Paulo, 05410-000, Brazil

Location

Related Publications (10)

  • 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.

    PMID: 23756431BACKGROUND

  • 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.

    PMID: 15753425BACKGROUND

  • 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.

    PMID: 15193031BACKGROUND

  • 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.

    PMID: 17222319BACKGROUND

  • 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.

    PMID: 19934558BACKGROUND

  • 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.

    PMID: 8736107BACKGROUND

  • 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.

    PMID: 14519601BACKGROUND

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

    PMID: 21346569BACKGROUND

  • 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.

    PMID: 15545210BACKGROUND

  • 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.

    PMID: 28512443DERIVED

MeSH Terms

Conditions

Brain Injuries, TraumaticPost-Concussion Syndrome

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesBrain ConcussionHead Injuries, ClosedWounds, Nonpenetrating

Study Officials

  • Robson L Amorim, MD

    University of Sao Paulo Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2014

First Posted

November 17, 2014

Study Start

October 1, 2014

Primary Completion

January 1, 2026

Study Completion (Estimated)

April 1, 2028

Last Updated

January 30, 2024

Record last verified: 2024-01

Locations

BR(1)