Analysis of TCLT in TBI Patients: a Prospective, Randomized Controlled Trial

University of Sao Paulo General Hospital

Status: Completed

Conditions: Brain Injury; Cognitive Deficits

Treatments: Device: Sham; Device: Transcranial LED Therapy (TCLT)

Study type: Interventional

Funder types: Other

Identifiers

NCT02393079

TCLT/DIP

Details and patient eligibility

About

The purpose of this study is to evaluate the early and late effects of Transcranial Led Therapy (TLTC) in memory and executive functions in patients with moderate and severe TBI history (TBI time longer than 3 months).

Full description

In the current study patients in the outpatient center - Neurotrauma Unit at University of São Paulo (HCFMUSP) diagnosed with moderate / severe blunt head trauma that meet the inclusion criteria will be divided randomly and blindly in two groups: Group A (n = 18) will receive stimulation through active helmet and Group B (n = 18) given placebo stimulation or sham through the inactive helmet. All patients will be subjected to 3 times of neuropsychological assessment: Study 1 (E1) - up to 4 weeks before the start of TLTC sessions; Study 2 (E2) - a week after the end of TLTC; and Study 3 (E3) - three months after the intervention. The evaluations will take in order to verify the early and late effects of TLTC in attention, memory and executive functions in patients with moderate and severe TBI.

Enrollment: 36 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical and radiological diagnosis of traumatic brain injury
• Must be able to sign the Informed Consent Form
• Patients with TBI beginning three months after injury

Exclusion criteria

• Impairment of language and / or limiting engine
• Extensive Cranial vault defects
• Presence of uncontrolled post-TBI epilepsy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 2 patient groups

Active helmet LED

Experimental group

Description:

Description of the intervention: 18 patients will undergo 18 sessions of transcranial LED therapy (ACTIVE HELMET) with 30 minutes duration each. The sessions take place over 6 weeks. The therapy will be performed with a helmet that covers the frontal and parietal region.

Treatment:

Device: Transcranial LED Therapy (TCLT)

Sham group

Sham Comparator group

Description:

Description of the intervention: 18 patients will undergo 18 sessions of transcranial LED therapy (INACTIVE HELMET) with 30 minutes duration each. The sessions take place over 6 weeks. The therapy will be performed with a helmet that covers the frontal and parietal region.

Treatment:

Device: Sham