Brain Stimulation for Mild Traumatic Brain Injury

Phase 2Active Not RecruitingNCT02292589

University of Sao Paulo General Hospital20 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Traumatic Brain Injury Post-Concussion Symptoms

Interventions

Frontal StimulationDEVICE

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

Temporal StimulationDEVICE

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

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

HC University of Sao Paulo - Medical School

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

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.

Time frame: immediately after the stimulation

Data from ClinicalTrials.gov

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