NCT02292589

Brain Stimulation for Mild Traumatic Brain Injury

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Frontal Stimulation	The patient will receive anodal tDCS on left dorsolateral prefrontal cortex with an intensity of 1.5 mA for 20 minutes.
DEVICE	Temporal Stimulation	The patient will receive anodal tDCS on left temporal cortex with an intensity of 1.5 mA for 20 minutes.
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.

Timeline

• Start date: 2014-10-01
• Primary completion: 2026-01-01
• Completion: 2028-04-01
• First posted: 2014-11-17
• Last updated: 2024-01-30

Locations

1 site across 1 country: Brazil