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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02292589

Acronym

tDCS/PPCS

Enrollment

Registered

2014-11-17

Start date

2014-10-31

Completion date

2028-04-30

Last updated

2024-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Concussion Symptoms, Traumatic Brain Injury

Keywords

Traumatic Brain Injury, Post concussion syndrome, Transcranial Direct Current Stimulation, Neuromodulation

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.

Interventions

DEVICEFrontal Stimulation

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

DEVICETemporal Stimulation

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

DEVICESham 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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026