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Trial record 3 of 28 for:    Recruiting, Not yet recruiting, Available Studies | "Hyperbaric Oxygenation"

Hyperbaric Oxygen Therapy Effect on Post Concussion Syndrome in Children (TBIPED)

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ClinicalTrials.gov Identifier: NCT03339037
Recruitment Status : Recruiting
First Posted : November 13, 2017
Last Update Posted : November 13, 2017
Sponsor:
Information provided by (Responsible Party):
Assaf-Harofeh Medical Center

Brief Summary:

Due its high incidence, mTBI and its consequences of PPCS are a major public health issue. There is no consensus regarding the treatment of PPCS in pediatrics. Relying on its results in adults, HBOT offers a promising new direction of treatment, which targets the basic pathological processes responsible for post-concussion symptoms.

The effect of hyperbaric oxygen therapy in pediatric TBI has never been evaluated.

The aim of the current study is to evaluate in a prospective cross-over, randomized study, the effect of HBOT on children with PPCS due to mild TBI.


Condition or disease Intervention/treatment Phase
Hyperbaric Oxygen Therapy Traumatic Brain Injury Post-Concussion Syndrome Device: Hyperbaric oxygen therapy Device: Normobaric air SHAM Not Applicable

Detailed Description:

The study is designed as a prospective, randomized, controlled, cross-over two groups trial. The study will be conducted in the -Sagol center for hyperbaric medicine and research and the children neurological unit of Assaf Harofeh Medical Center, Israel. Brain MRIs evaluation will be done the radiology department of Assaf-Harofeh Medical Center, Israel.

Study will include 70 patients After signing the informed consent (signed by the parents), patients will undergo computerized cognitive tests using the computerized Neurotrax and Moxo cognitive batteries. Patients who fulfill inclusion criteria will be included in the study.

After signing informed consent (by parents, at the prescreening phase), patients who fill inclusion criteria, will be randomized in 1:1 manner into the treated or the control-cross group. Randomization will be performed using a computer software according to patient id. After the randomization, patients will be invited for baseline evaluation that will include full review of their medical status and complete physical examination.

All patients will go through evaluation of their neurocognitive function using further neurocognitive testing battery, questionnaires and brain imaging (perfusion MRI+DTI, SPECT). In cases of brain tumors, skull base tumors, encephalomalacia findings in MRI, patients will be excluded.

The patients in the treated group will be evaluated three time - at baseline, after 3 months of HBOT treatment and after another consequent 3 months period from treatment (6 months from baseline). The patients of the cross group will be evaluated three times as well- at baseline, after 3 month control period without hyperbaric treatment and after a consequent 3 month period of HBOT treatment.

The following HBOT treatment protocol will be practiced: The patients will go through 60 HBOT treatments (each treatment session will be given on a separate day), distributed over three months (five days a week). Each session will be for 60 minutes in 100% oxygen atmosphere and at pressure of 1.5 ATA.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: randomized controlled trial using a SHAM treatment compared to treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: randomization by computer, sham/ treatment will be known to chamber technicians and nurses but not to investigators
Primary Purpose: Treatment
Official Title: Application of Hyperbaric Oxygen Therapy for Children Suffering From Prolonged Post-Concussion Syndrome Due to Mild Traumatic Brain Injury
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Active Comparator: Hyperbaric oxygen therapy

60 Hyperbaric oxygen sessions in a multiplace hyperbaric chamber (HAUX-Life-Support GmbH). each session 1.5 ATA of 100% oxygen for 1 hour.

1 meter per minute compression and decompression.

Device: Hyperbaric oxygen therapy
60 HBOT sessions at 2 ATA 100% oxygen

Sham Comparator: Normobaric air SHAM

60 sessions in a multiplace hyperbaric chamber (HAUX-Life-Support GmbH). Each session at 1 ATA of 21% oxygen (air) for 1 hour.

1 meter per minute compression and decompression. after 3 months, patients will be crossed over and treated with 60 sessions of treatment

Device: Normobaric air SHAM
60 sessions at 1 ATA 21% oxygen (air)




Primary Outcome Measures :
  1. Cognitive function [ Time Frame: at 3 months ]
    General,Attention, Memory, Executive functions, Visual spatial and Verbal memory indices Index (scale 0-100) will be measured using the computerized standardized Neurotrax battery test. Each of above cognitive indices is computed as a normalized combined score of 2-3 cognitive tests. (At baseline, this battery will be conducted as part of the screening).

  2. Cognitive function [ Time Frame: at 6 months ]
    General,Attention, Memory, Executive functions, Visual spatial and Verbal memory indices Index (scale 0-100) will be measured using the computerized standardized Neurotrax battery test. Each of above cognitive indices is computed as a normalized combined score of 2-3 cognitive tests. (At baseline, this battery will be conducted as part of the screening).


Secondary Outcome Measures :
  1. Post concussion syndrome symptoms [ Time Frame: baseline, 3 months and 6 months from baseline ]
    Patients and their parents will fill questionaries' Postconcussion Symptom Inventory (PCSI) (scale 0-21) at baseline and at their second and/or third evaluations

  2. Health Behaviour inventory [ Time Frame: baseline, 3 months and 6 months from baseline ]
    Patients and their parents will fill questionaries' Health Behaviour inventory (scale 50-200) at baseline and at their second and/or third evaluations

  3. Balance [ Time Frame: baseline, 3 months and 6 months from baseline ]
    Patients will undergo balance tests (BERG Balance Scale) (scale 0-56) at each of the evaluations

  4. Brain functional imaging [ Time Frame: baseline, 3 months ]
    Patients will undergo photon emission tomography (PET-CT) using FDG at each of the three evaluations

  5. Brain microstructural imaging [ Time Frame: baseline, 3 months and 6 months from baseline ]
    Imaging will be conducted in using a 3 Tesla system (Siemens, Germany). The MRI protocol includes the following sequences: Axial T1, T2, FLAIR, Axial Diffusion weighted, Axial T1-PostGadollinium , dynamic contrast enhancement (DSC), diffusion tensor imaging (DTI)

  6. Brain perfusion [ Time Frame: baseline, 3 months and 6 months from baseline ]
    Imaging will be conducted in using a 3 Tesla system (Siemens, Germany). The MRI protocol includes the following sequences: Axial T1, T2, FLAIR, Axial Diffusion weighted, Axial T1-PostGadollinium , dynamic contrast enhancement (DSC), diffusion tensor imaging (DTI)

  7. Quality of life [ Time Frame: baseline, 3 months and 6 months from baseline ]
    Patients and their parents will complete questionnaires Pediatric Quality of Life inventory (PedsQL) - multi-dimensional concept that includes domains related to physical, mental, emotional, and social functioning.

  8. Brain network analysis [ Time Frame: baseline, 3 months and 6 months from baseline ]
    Patients will undergo resting state EEG as well as EEG during performing cognitive tasks ,using a 64 electrodes cap.

  9. Behaviour [ Time Frame: baseline, 3 months and 6 months from baseline ]
    The parents and their teachers will complete the following questionnaire at baseline and at their second and/or third evaluations. The rating scales are available for parent (Conners 3-P), teacher (Conners 3-T) and self-report (Conners 3-SR).Subscales include inattention, hyperactivity/impulsivity, learning, executive functioning, aggression and peer relations, as well as subscales mapping onto DSM-IV criteria for ADHD (inattentive), ADHD (hyperactive-impulsive), ADHD combined, Conduct Disorder, and Oppositional-Defiant Disorder. Means and standard deviations for the global index vary dependent on age (for 6 year-olds the mean is 5.15 with a standard deviation of 3.97; means for 17 to 18 year-olds are 3.90 with a standard deviation of 4.00). Raw scores are usually converted to T-scores or percentile scores relative to normative data. T-scores above 60 (percentiles above 84) are considered clinically significant.

  10. Executive functions [ Time Frame: baseline, 3 months and 6 months from baseline ]

    The parents and their teachers will complete the Behavior Rating Inventory of Executive Function(BRIEF) questionnaire at baseline and at their second and/or third evaluations.

    he Global Executive Composite (GEC) is an overarching summary score that incorporates all of the BRIEF clinical scales. The possible range of scores for teachers is 0 to 24.




Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • - Ages 8-15
  • Mild TBI (defined as loss of consciousness with duration of 0-30 minutes, post-traumatic amnesia with duration of less than 24 hours, Glasgow Coma Scale grade of 13-15) within 6 months-3 years prior to the inclusion in the study.
  • Presence of at least two PCS as measured by the Post-Concussion Symptom Inventory )see attached) (there's a RCT now recruitingwith at least 1 and not 2) for at least 3 months.
  • No change in cognitive or behavioral functions during one month prior to the beginning of the study (according to parents/teachers report).

Screening protocol:

After signing the informed consent (signed by the parents), patients will undergo computerized cognitive tests using the computerized Neurotrax and Moxo cognitive batteries. Patients who fulfill inclusion criteria will be included in the study.

Inclusion criteria:

- Objective cognitive impairment: a decrease of at least 1 standard deviation (SD) from same age mean score in one or more of the following indices : memory, attention, information processing speed, executive functions in both Neurotrax

Exclusion Criteria:

  • - Dynamic neurologic improvement or worsening during the past month (according to parents/teachers report);
  • Had been treated with HBOT for any other reason prior to their inclusion;
  • Chest pathology incompatible with pressure changes (including asthma)
  • Inner ear disease;
  • Claustrophobia;
  • Inability to perform awake brain MRI test
  • Previous neurologic conditions (eg. Epilepsy, neuromuscular diseases, metabolic diseases, etc.)
  • Brain tumors
  • Skull base fractures
  • Active malignancy
  • s/p neurosurgery that included: ventricular drainage, subdural hematomas drainage, epidural hematomas drainage, intracerebral hemorrhage evacuation. Depressed fracture surgery, won't be excluded.
  • Encephalomalacia per MRI imaging
  • No informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03339037


Locations
Israel
Assaf-Harofeh Medical Center Recruiting
Zerifin, Israel, 70300
Contact: Shai efrati, MD    972-549-212-866    efratishai@013.net   
Principal Investigator: Amir Hadanny, MD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center

Responsible Party: Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT03339037     History of Changes
Other Study ID Numbers: 0120-16-ASF
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Assaf-Harofeh Medical Center:
HBOT
TBI
pediatrics
PCS
PPCS
concussion
traumatic brain injury
hyperbaric oxygen

Additional relevant MeSH terms:
Syndrome
Brain Injuries
Brain Injuries, Traumatic
Post-Concussion Syndrome
Disease
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Brain Concussion
Head Injuries, Closed
Wounds, Nonpenetrating