Diffuse Axonal Brain InjuryLED-TBINCT03281759
Transcranial LED Therapy for Severe Acute Traumatic Brain Injury
A study testing Transcranial LED Therapy (Active coil helmet) and Transcranial LED Therapy (Inactive coil helmet) in people with Diffuse Axonal Brain Injury and Traumatic Brain Injury, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate early and delayed effects of Transcranial LED Therapy (TCLT) and determinate whether this therapy is effective for cognitive rehabilitation of Diffuse Axonal Injury patients after Traumatic Brain Injury. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Diffuse Axonal Brain Injury, Traumatic Brain Injury
- What is being tested?
- Transcranial LED Therapy (Active coil helmet) and Transcranial LED Therapy (Inactive coil helmet)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2017to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1) Patient victims of Traumatic Brain Injury with Glasgow Coma Scale ≤8 on admission:
- Head CT scan showing diffuse axonal lesion.
- CT scan without focal surgical lesions (Marshall I and II) and no signs of intracranial hypertension.
- Transcranial Doppler and optic nerve sheath US with no signs of intracranial hypertension.
- Admission less than 8 hours of trauma.
Who cannot join
- History of drug or narcotic abuse.
- Emergence of surgical lesions or signs of intracranial hypertension in followup CTs.
- Transcranial Doppler or optic nerve sheath US presenting signs of intracranial hypertension.
- Psychiatric disorders.
- Injury severity score ≥3, according to the Abbreviated Injury Scale
Trial locations and contacts
1 site in 1 country.
Wellingson S Paiva, PHD contact
Brazil1 site, 1 recruiting
- Recruiting
University of Sao Paulo General Hospital
São Paulo, São Paulo, 05401-000
Joao G Santos, MD, +5511941989876, joao.gustavo.rps@gmail.com
About this study
Official title: Effects of Transcranial LED Therapy on the Cognitive Rehabilitation for Diffuse Axonal Injury Due to Severe Acute Traumatic Brain Injury: Randomized Clinical Trial.
The purpose of this study is to evaluate early and delayed effects of Transcranial LED Therapy (TCLT) and determinate whether this therapy is effective for cognitive rehabilitation of Diffuse Axonal Injury patients after Traumatic Brain Injury.
Read the detailed description
This is a randomized clinical trial of patient with diffuse axonal injury (DAI) secondary to severe Traumatic Brain Injury in its acute stage (less than 8h). It will be recruited thirty adult patients who will receive thirty minutes at three times per week for 6 weeks (18 sessions) of transcranial stimulation. Fifteen of them will be stimulated with LED helmet and the rest with a sham helmet identical to the LED one, but only with a similar red light emission. Patient who meet inclusion criteria will be assessed with Glasgow Outcome Scale Extended (GOS-E) evaluation in at least five different periods (Admission, before and after each stimulation, and at 3 and 6 months later in outpatient followup).
- Being tested
- Transcranial LED Therapy (Active coil helmet), Transcranial LED Therapy (Inactive coil helmet)
- Keywords
- Brain Injuries, Traumatic;, Diffuse Axonal Injury, Low-Level Light Therapy, Neurologic Manifestations, Quality of Life, Rehabilitation
- Medical subject headings
- Brain Injuries, Diffuse, Brain Injuries, Traumatic, Diffuse Axonal Injury, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial LED Therapy (Active coil helmet)Device
The patients will undergo 18 sessions of repetitive transcranial LED stimulation.
Transcranial LED Therapy (Inactive coil helmet)Device
The patients assigned to this group will undergo 18 sessions of transcranial LED but with an inactive coil, which will not generate LED emissions, only a similar red light color.
| Study group | Role | What they receive |
|---|---|---|
| Active Coil Helmet | Active comparator | The patients will undergo 18 sessions (627 nm, 70 mW/cm2, 10 J/cm2) at four points of the frontal and parietal region for 30 s each, totaling 120 s three times per week for 6 weeks, lasting 30 minutes of transcranial LED stimulation. Receives: Device: Transcranial LED Therapy (Active coil helmet) |
| Inactive Coil Helmet | Placebo comparator | The patients assigned to this group will undergo 18 sessions of transcranial LED but with an inactive coil, which will not generate LED emissions. Receives: Device: Transcranial LED Therapy (Inactive coil helmet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of early and delayed functional outcome measured by Glasgow Outcome Scale Extended (GOSE).
Evaluation of improvement of early and delayed functional outcome measured by Glasgow Outcome Scale Extended (GOSE) after stimulation in comparison to the placebo group.
Measured: Before stimulation and 1, 3 and 6 months after first stimulation
Secondary outcomes (2)
Improvement effects of transcranial LED in followup images measured by Marshall computed tomography scale and Adams grading scale for diffuse axonal injury.
Evaluation of early and delayed effects of Transcranial LED Therapy (TCLT) to improve followup computed tomography or magnetic resonance of DAI patients after Traumatic Brain Injury, measured by Marshal computed tomography scale, Adams grading scale for diffuse axonal injury and a protocol published by Hamdeh et al. (doi: 10.1089/neu.2016.4426) which graduates the magnitude of diffuse axonal lesion.
Measured: Before stimulation and 1, 3 and 6 months after first stimulation
Hemodynamic improvement effect of transcranial LED measured by transcranial doppler (systolic and diastolic velocity of the left middle cerebral and basilar arteries, and the pulsatility index and resistance index values).
Improvement evaluation of effects of LED therapy in hemodynamic change through transcranial doppler, measuring systolic and diastolic velocity of the left middle cerebral and basilar arteries, and the pulsatility index and resistance index values.
Measured: Before stimulation and 1, 3 and 6 months after first stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start1 Oct 2017 (estimated)
- Primary completion1 Oct 2018 (estimated)
- Study completion1 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diffuse Axonal Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wellingson S Paiva, PhD, Study chair, University of Sao Paulo General HospitalJoao G Santos, MD, Principal investigator, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281759
- Sponsor's protocol ID
- 15425
- Acronym
- LED-TBI
- Status last verified
- Aug 2017
- First submitted
- 4 Sep 2017
- Last updated
- 13 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Santos JGRPD, Zaninotto ALC, Zangaro RA, Carneiro AMC, Neville IS, de Andrade AF, Teixeira MJ, Paiva WS. Effects of transcranial LED therapy on the cognitive rehabilitation for diffuse axonal injury due to severe acute traumatic brain injury: study protocol for a randomized controlled trial. Trials. 2018 Apr 24;19(1):249. doi: 10.1186/s13063-018-2632-5.
PubMed 29690927
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial LED Therapy on the Cognitive Rehabilitation for Diffuse Axonal Injury Due to Severe Acute Traumatic Brain Injury: Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03281759
- Acronym / sponsor ID
- LED-TBI / 15425
- Keywords
- Brain Injuries, Traumatic;, Diffuse Axonal Injury, Low-Level Light Therapy, Neurologic Manifestations, Quality of Life, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2017 (estimated)
- Primary completion
- 1 Oct 2018 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 13 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate early and delayed effects of Transcranial LED Therapy (TCLT) and determinate whether this therapy is effective for cognitive rehabilitation of Diffuse Axonal Injury patients after Traumatic Brain Injury.
Detailed description
This is a randomized clinical trial of patient with diffuse axonal injury (DAI) secondary to severe Traumatic Brain Injury in its acute stage (less than 8h). It will be recruited thirty adult patients who will receive thirty minutes at three times per week for 6 weeks (18 sessions) of transcranial stimulation. Fifteen of them will be stimulated with LED helmet and the rest with a sham helmet identical to the LED one, but only with a similar red light emission. Patient who meet inclusion criteria will be assessed with Glasgow Outcome Scale Extended (GOS-E) evaluation in at least five different periods (Admission, before and after each stimulation, and at 3 and 6 months later in outpatient followup).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Coil Helmet | Active comparator | Device: Transcranial LED Therapy (Active coil helmet)The patients will undergo 18 sessions (627 nm, 70 mW/cm2, 10 J/cm2) at four points of the frontal and parietal region for 30 s each, totaling 120 s three times per week for 6 weeks, lasting 30 minutes of transcranial LED stimulation. |
| Inactive Coil Helmet | Placebo comparator | Device: Transcranial LED Therapy (Inactive coil helmet)The patients assigned to this group will undergo 18 sessions of transcranial LED but with an inactive coil, which will not generate LED emissions. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Head CT scan showing diffuse axonal lesion.
- CT scan without focal surgical lesions (Marshall I and II) and no signs of intracranial hypertension.
- Transcranial Doppler and optic nerve sheath US with no signs of intracranial hypertension.
- Admission less than 8 hours of trauma.
Key exclusion criteria (5 listed)
- History of drug or narcotic abuse.
- Emergence of surgical lesions or signs of intracranial hypertension in followup CTs.
- Transcranial Doppler or optic nerve sheath US presenting signs of intracranial hypertension.
- Psychiatric disorders.
- Injury severity score ≥3, according to the Abbreviated Injury Scale
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial LED Therapy (Active coil helmet)The patients will undergo 18 sessions of repetitive transcranial LED stimulation. | Device | Active Coil Helmet |
| Transcranial LED Therapy (Inactive coil helmet)The patients assigned to this group will undergo 18 sessions of transcranial LED but with an inactive coil, which will not generate LED emissions, only a similar red light color. | Device | Inactive Coil Helmet |
Primary outcome
Improvement of early and delayed functional outcome measured by Glasgow Outcome Scale Extended (GOSE).
Time frame: Before stimulation and 1, 3 and 6 months after first stimulation
Evaluation of improvement of early and delayed functional outcome measured by Glasgow Outcome Scale Extended (GOSE) after stimulation in comparison to the placebo group.
2 secondary outcomes
Improvement effects of transcranial LED in followup images measured by Marshall computed tomography scale and Adams grading scale for diffuse axonal injury.
Time frame: Before stimulation and 1, 3 and 6 months after first stimulation
Hemodynamic improvement effect of transcranial LED measured by transcranial doppler (systolic and diastolic velocity of the left middle cerebral and basilar arteries, and the pulsatility index and resistance index values).
Time frame: Before stimulation and 1, 3 and 6 months after first stimulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
- Derived from this study: PubMed 29690927Santos JGRPD, Zaninotto ALC, Zangaro RA, Carneiro AMC, Neville IS, de Andrade AF, Teixeira MJ, Paiva WS. Effects of transcranial LED therapy on the cognitive rehabilitation for diffuse axonal injury due to severe acute traumatic brain injury: study protocol for a randomized controlled trial. Trials. 2018 Apr 24;19(1):249. doi: 10.1186/s13063-018-2632-5.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wellingson S Paiva, PHD contact
Wellingson S Paiva, PhD study chair
University of Sao Paulo General Hospital
Joao G Santos, MD principal investigator
University of Sao Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial LED Therapy (Active coil helmet) and Transcranial LED Therapy (Inactive coil helmet) in people with Diffuse Axonal Brain Injury and Traumatic Brain Injury, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joao G Santos, MD (+5511941989876, joao.gustavo.rps@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of early and delayed functional outcome measured by Glasgow Outcome Scale Extended (GOSE). (time frame: Before stimulation and 1, 3 and 6 months after first stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03281759, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2017.