## Protocol Section
### Identification Module
**NCT ID:** NCT02393079

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

**Official Title:** The Effects of Transcranial LED Therapy (TCLT) in Patients With Traumatic Brain Injury (TBI): a Prospective, Randomized Controlled Trial

#### Organization Study ID Info
**ID:** TCLT/DIP
#### Organization
**Class:** OTHER
**Full Name:** University of Sao Paulo General Hospital
### Status Module
#### Completion Date
**Date:** 2019-11

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-04-29

**Type:** ACTUAL

**Last Update Submit Date:** 2022-04-22

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-06

**Type:** ACTUAL

#### Start Date
**Date:** 2015-01

**Status Verified Date:** 2022-04

#### Study First Post Date
**Date:** 2015-03-19
**Type:** ESTIMATED
**Study First Submit Date:** 2015-02-20
**Study First Submit QC Date:** 2015-03-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Sao Paulo General Hospital

#### Responsible Party

**Investigator Affiliation:** University of Sao Paulo General Hospital

**Investigator Full Name:** Guilherme da Cruz Ribeiro Poiani

**Investigator Title:** Principal Investigator - clinical neuropsychologist

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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).

**Detailed 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.

### Conditions Module

**Conditions:**

- Brain Injury

- Cognitive Deficits

**Keywords:**

- Traumatic Brain Injury

- Cognitive

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 36

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Device: Transcranial LED Therapy (TCLT)

**Label:** Active helmet LED

**Type:** EXPERIMENTAL

#### Arm Group 2

**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.

**Intervention Names:**

- Device: Sham

**Label:** Sham group

**Type:** SHAM_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Active helmet LED

**Description:** Whereas the geometry of the skull and to uniformly distribute the light radiation, the TLTC is applied using as light source a set of LEDs installed in a helmet, emitting radiation in the range between 600nm and 650nm with a peak at 630nm, so in the red region.

**Name:** Transcranial LED Therapy (TCLT)

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Sham group

**Description:** A SHAM identical helmet will be used in the control group.

**Name:** Sham

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Measurement of each patient's inhibitory control by means of a test that causes them to cognitively suppress a habitual response in favor of a less habitual one. The results of patients with shorter response times indicate better positions in the tables, according to age. Examples of the average time (in seconds) of best results are between 17-29 years (11.79) and 80+ (19.31), any time longer than these indicates decreasing results.

**Measure:** Evidence of improvement in inhibitory control measured by cognitive assessment (Stroop Test - Victoria Version) in patients undergoing intervention with an active LED helmet.

**Time Frame:** Three times: Up to one week before to start intervention, one week and three months after end the intervention

#### Secondary Outcomes

**Description:** Apply a neuropsychological assessment battery focused on executive functioning, attentional processes and memory to measure the effects of the active led helmet compared to the use of the sham device.

**Measure:** Assess the immediate and late effects of the intervention on victims of moderate or severe TBI in the following cognitive domains: executive functioning, attentional processes and memory.

**Time Frame:** Three times: Up to one week before to start intervention, one week and three months after end the intervention

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 60 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Sao Paulo

**Country:** Brazil

**Facility:** Clinics Hospital - University of Sao Paulo Medical School

**State:** SP

**Zip:** 054010-000

#### Overall Officials

**Official 1:**

**Affiliation:** Clinics Hospital - University of Sao Paulo Medical School

**Name:** Wellingson S Paiva, MD PhD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Poiani GDCR, Zaninotto AL, Carneiro AMC, Zangaro RA, Salgado ASI, Parreira RB, de Andrade AF, Teixeira MJ, Paiva WS. Photobiomodulation using low-level laser therapy (LLLT) for patients with chronic traumatic brain injury: a randomized controlled trial study protocol. Trials. 2018 Jan 8;19(1):17. doi: 10.1186/s13063-017-2414-5.

**PMID:** 29310710

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000006259

- Term: Craniocerebral Trauma

- ID: D000020196

- Term: Trauma, Nervous System

- ID: D000019965

- Term: Neurocognitive Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC26

- Name: Wounds and Injuries

### Condition Browse Module - Browse Leaves

- ID: M29705

- Name: Cognitive Dysfunction

- Relevance: HIGH

- As Found: Cognitive Deficits

- ID: M5207

- Name: Brain Injuries

- Relevance: HIGH

- As Found: Brain Injury

- ID: M628

- Name: Brain Injuries, Traumatic

- Relevance: LOW

- As Found: Unknown

- ID: M6301

- Name: Cognition Disorders

- Relevance: HIGH

- As Found: Cognitive Deficits

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9349

- Name: Craniocerebral Trauma

- Relevance: LOW

- As Found: Unknown

- ID: M22023

- Name: Trauma, Nervous System

- Relevance: LOW

- As Found: Unknown

- ID: M21836

- Name: Neurocognitive Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001930

- Term: Brain Injuries

- ID: D000003072

- Term: Cognition Disorders

- ID: D000060825

- Term: Cognitive Dysfunction

### Misc Info Module

- Version Holder: 2024-05-24
