Brain Stimulation for Mild Traumatic Brain Injury (tDCS/PPCS)

University of Sao Paulo General Hospital

Status and phase: Active, not recruiting; Phase 2

Conditions: Traumatic Brain Injury; Post-Concussion Symptoms

Treatments: Device: Temporal Stimulation; Device: Sham Stimulation; Device: Frontal Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02292589

RAHC-001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 3 patient groups

Frontal Stimulation

Experimental group

Description:

Left dorsolateral prefrontal cortex stimulation

Treatment:

Device: Frontal Stimulation

Temporal Stimulation

Experimental group

Description:

Left temporal cortex stimulation

Treatment:

Device: Temporal Stimulation

Sham Stimulation

Experimental group

Description:

Sham stimulation

Treatment:

Device: Sham Stimulation