Brain Stimulation for Mild Traumatic Brain Injury

Phase 2

Active, not recruiting

• Conditions: Traumatic Brain Injury; Post-Concussion Symptoms
• Interventions: Device: Frontal Stimulation; Device: Sham Stimulation; Device: Temporal Stimulation

• Registration Number: NCT02292589
• Lead Sponsor: University of Sao Paulo General Hospital

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).

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-11-12
• Study First Submitted QC: 2014-11-12
• Study First Posted: 2014-11-17
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-30
• Primary Completion: 2026-01
• Study Completion: 2028-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Frontal Stimulation	Frontal Stimulation	Left dorsolateral prefrontal cortex stimulation
Sham Stimulation	Sham Stimulation	Sham stimulation
Temporal Stimulation	Temporal Stimulation	Left temporal cortex stimulation

Primary Outcome Measures

Name	Time	Method
Evidence of improvement of patient's episodic memory and executive function measured by neuropsychological test	immediately after the stimulation	HVLT, Wechsler memory scale, Inhibitory control test(ICT) and Block-tapping test.

Trial Locations

Locations (1)

HC University of Sao Paulo - Medical School; 🇧🇷 São Paulo, SP, Brazil