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OpenTrials
Active, Not Recruiting

NCT Number: NCT02292589

Brain Stimulation for Mild Traumatic Brain Injury

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Traumatic Brain Injury Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Post-Concussion Symptoms Post-Concussion Syndrome Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

HC University of Sao Paulo - Medical School

São Paulo, 05410-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Frontal Stimulation

Device

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

Temporal Stimulation

Device

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

Sham stimulation

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

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

Acronym: tDCS/PPCS

Important dates

Study start
2014
Primary completion
2026
Study completion
2028
First posted
Nov 17, 2014
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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