NCT02393079

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2015

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 19, 2015

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

April 29, 2022

Status Verified

April 1, 2022

Enrollment Period

4.4 years

First QC Date

February 20, 2015

Last Update Submit

April 22, 2022

Conditions

Brain InjuryCognitive Deficits

Keywords

Traumatic Brain InjuryCognitive

Outcome Measures

Primary Outcomes (1)

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

    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.

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

Secondary Outcomes (1)

  • 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.

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

Study Arms (2)

Active helmet LED

EXPERIMENTAL

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.

Device: Transcranial LED Therapy (TCLT)

Sham group

SHAM COMPARATOR

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.

Device: Sham

Interventions

Transcranial LED Therapy (TCLT)DEVICE

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.

Active helmet LED
ShamDEVICE

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

Sham group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinics Hospital - University of Sao Paulo Medical School

São Paulo, São Paulo, 054010-000, Brazil

Location

Related Publications (1)

  • 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: 29310710DERIVED

MeSH Terms

Conditions

Brain InjuriesCognition DisordersBrain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesNeurocognitive DisordersMental Disorders

Study Officials

  • Wellingson S Paiva, MD PhD

    Clinics Hospital - University of Sao Paulo Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator - clinical neuropsychologist

Study Record Dates

First Submitted

February 20, 2015

First Posted

March 19, 2015

Study Start

January 1, 2015

Primary Completion

June 1, 2019

Study Completion

November 1, 2019

Last Updated

April 29, 2022

Record last verified: 2022-04

Locations

BR(1)