Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:28 AM
Study NCT ID:
NCT07430150
Status:
RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long Lasting Effect of Hyperbaric Oxygen Therapy on Cognitive Function in Traumatic Brain Injury Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2030-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-18', 'studyFirstSubmitDate': '2026-02-18', 'studyFirstSubmitQcDate': '2026-02-18', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NeuroTrax cognitive battery test', 'timeFrame': 'Change from Baseline immediately after the intervention', 'description': 'Cognitive function will be evaluated using the NeuroTrax (Mindstreams) cognitive computerized cognitive testing battery (NeuroTrax Corporation, Bellaire, TX) \\[70\\]. This assessment comprises of several cognitive tests that evaluate various aspects of brain capabilities'}, {'measure': 'CANTAB cognitive battery test', 'timeFrame': 'Change from Baseline immediately after the intervention', 'description': "Subjects' cognitive functions will also be assessed by CANTAB computerized cognitive tests (Cambrdige cognition , England) \\[72\\]. The CANTAB is a semiautomated test battery which can be administered on a laptop PC and more recently has been modified for administration on a handheld tablet"}, {'measure': 'Quality of Life: SF-36 Questionnaire', 'timeFrame': 'Change from Baseline immediately after the intervention', 'description': 'SF-36 is a set of generic, coherent, and easily administered quality-of-life measures \\[75\\]. These measures rely upon patient self-reporting and are now widely utilized by researchers, managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients.'}, {'measure': 'Post-concussion syndrome symptoms: BC-PSI Questionnaire', 'timeFrame': 'Change from Baseline immediately after the intervention', 'description': 'The BC-PSI is a 16-item measure designed to assess the presence and severity of postconcussion symptoms \\[76\\]. The test was based on ICD-10 criteria for PCS, and requires the patient to rate the frequency and intensity of 13 symptoms (i.e., headaches, dizziness or light-headedness, nausea or feeling sick, fatigue, sensitivity to noises, irritability, sadness, nervousness or tension, temper problems, poor concentration, memory problems, reading difficulty, and sleep disturbance), and the effect of three life problems on daily living (i.e., greater present vs. past effects of alcohol consumption, worrying and dwelling on symptoms, and self-perception of brain damage). The three life problems are rated on a scale from 1 to 5, where 1 = not at all and 5 = very much.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hyperbaric Therapy'], 'conditions': ['TBI (Traumatic Brain Injury)']}, 'descriptionModule': {'briefSummary': 'Purpose of the trial, rationale including definition of quantitative measures and description of participant recruitment:\n\nBackground and rationale:\n\nTraumatic brain injury (TBI) is one of the most common causes of disability and death in the general population \\[1\\]. Recent studies have shown that hyperbaric oxygen therapy helps improve cognitive function and quality of life in patients with chronic neurological deficits after traumatic brain injury of various severities, due to changes in brain neuroplasticity \\[2-4\\]. To date, only a few studies have examined the sustained effect of hyperbaric therapy on somatic, cognitive, or emotional symptoms in this population. Only two studies examined persistent effects in the range of 6 to 12 months after the end of a series of treatments \\[5-6\\].\n\nStudy objective:\n\nThe aim of the current study is to evaluate the cognitive functions of patients who suffered brain injury due to traumatic head injury and were previously treated in a hyperbaric chamber between one and four years after the end of treatment.', 'detailedDescription': "Study Protocol Summary:\n\nLong-term effect of hyperbaric oxygen therapy on cognitive functions in patients after traumatic brain injury\n\nStudy number: 0172-21-ASF Protocol number: 0172-21-ASF Protocol date: July 12, 2021 Protocol version: 1.0 Study type: No investigational product\n\nPurpose of the trial, rationale including definition of quantitative measures and description of participant recruitment:\n\nBackground and rationale:\n\nTraumatic brain injury (TBI) is one of the most common causes of disability and death in the general population \\[1\\]. Recent studies have shown that hyperbaric oxygen therapy helps improve cognitive function and quality of life in patients with chronic neurological deficits after traumatic brain injury of various severities, due to changes in brain neuroplasticity \\[2-4\\]. To date, only a few studies have examined the sustained effect of hyperbaric therapy on somatic, cognitive, or emotional symptoms in this population. Only two studies examined persistent effects in the range of 6 to 12 months after the end of a series of treatments \\[5-6\\].\n\nStudy objective:\n\nThe aim of the current study is to evaluate the cognitive functions of patients who suffered brain injury due to traumatic head injury and were previously treated in a hyperbaric chamber between one and four years after the end of treatment.\n\nParticipant recruitment procedure:\n\nParticipants who were treated with a series of hyperbaric chamber treatments at Shamir Medical Center between 2017 and 2021 will be identified. Patients will be invited by telephone to participate in the study; those who agree will be summoned to the Sagol Center, will sign an informed consent form, and will undergo a cognitive assessment.\n\nDetailed study plan and clinical follow-up (during and after treatment):\n\nEligible participants will be invited for an assessment visit that will include: signing the informed consent form, self-completion of validated computerized questionnaires, and a computerized cognitive assessment test. In addition, cognitive assessment results performed before and after the hyperbaric treatment series will be extracted from the patients' medical records, as well as demographic data, comorbidities, type and severity of the injury, time since the event, symptoms and changes reported during the hyperbaric treatment.\n\nOutcome assessment:\n\nStudy outcomes will be evaluated by examining the following parameters:\n\nCognitive functions: memory, processing speed, attention and executive functions will be assessed using Neurotrax software and the CANTAB battery.\n\nQuality of life measures: using the SF-36 (The Short Form 36 Health Survey Questionnaire).\n\nPost-concussion symptoms following traumatic brain injury: using the BC-PSI (British Columbia Postconcussion Symptom Inventory).\n\nStatistical analysis:\n\nContinuous data with normal distribution will be presented as mean ± standard deviation. Continuous data that are not normally distributed will be reported as median and interquartile range. Categorical data will be presented as proportions. Unpaired t-tests will be used to compare continuous data between two groups; Chi-Square/Fisher's Exact tests will be used to compare categorical data. The longitudinal effect of the treatment will be examined using repeated measures ANOVA, with multiple-comparison correction performed using the FDR (false discovery rate) test. A p-value below 0.05 will be considered statistically significant. Statistical analysis will be performed using Matlab Version 2020b.\n\nNumber of participants at this center:\n\n100\n\nAge range:\n\nOver 18 years\n\nSex:\n\nWomen and men\n\nInclusion criteria (main):\n\nSubjects who were over 18 years old at the time of hyperbaric treatment. Subjects with chronic neurological deficits after traumatic brain injury of any severity who received hyperbaric chamber treatment.\n\nCompleted a series of at least 50 hyperbaric chamber treatments at Shamir Medical Center and underwent two computerized cognitive tests (before and after the treatment series).\n\nExclusion criteria (main):\n\nInability to perform a computerized cognitive test. A subsequent head injury or stroke after completion of the hyperbaric treatment series.\n\nKnown history of psychiatric illness. Active malignancy. Use of illicit substances or medications that affect cognitive function. Inability to sign informed consent.\n\nCriteria for withdrawal from the study:\n\nNoncompliance with the protocol\n\nConsideration of inclusion of pregnant women, special populations-children and those lacking decision-making capacity (including ethical aspects, benefits to participants versus risks and discomfort):\n\nNot included\n\nDuration of treatment per participant and total study duration including post-study follow-up:\n\n12 months\n\nReferences\n\n1. Coronado VG, Xu L, Basavaraju SV, McGuire LC, Wald MM, et al. Surveillance for traumatic brain injury-related deaths; United States, 1997-2007.\n2. Tal S, Hadanny A, Berkovitz N, Sasson E, Ben-Jacob E, et al. (2015) Hyperbaric oxygen may induce angiogenesis in patients suffering from prolonged post-concussion syndrome due to traumatic brain injury. Restor Neurol Neurosci 33: 943-951.\n3. Boussi-Gross R, Golan H, Fishlev G, Bechor Y, Volkov O, et al. (2013) Hyperbaric oxygen therapy can improve post concussion syndrome years after mild traumatic brain injury - randomized prospective trial. PLoS One 8: e79995.\n4. Hadanny A, Rittblat M, Bitterman M, May-Raz I, Suzin G, et al. (2020) Hyperbaric oxygen therapy improves neurocognitive functions of post-stroke patients - a retrospective analysis. Restor Neurol Neurosci 38: 93-107.\n5. Lin J-W, Tsai J-T, Lee L-M, Lin C-M, Hung C-C, et al. (2008) Effect of hyperbaric oxygen on patients with traumatic brain injury. Reconstructive Neurosurgery: Springer. pp. 145-149.\n6. Deru K, Price RC, Williams CS, Orrison WW, Walker JM, et al. (2018) Hyperbaric oxygen for post-concussive symptoms in United States military service members: a randomized clinical trial."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include 100 participants, male and female, aged 18 years or older, who have been diagnosed with TBI and meet the following inclusion/exclusion criteria.\n\nPatients will be recruited for the study from the Shamir (Assaf Harofeh) Medical Center database.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosed with traumatic brain injury\n2. Age 18 years or older at treatment\n3. Completed a 60 session hyperbaric treatment course at the Sagol Center for Hyperbaric Medicine and Research, Shamir Medical Center (Assaf Harofeh), and performed a neurocognitive evaluation by the computerized test Neurotrax.\n4. Willing and able to sign an informed consent. -\n\nExclusion Criteria:\n\n1. An inability to perform a neurocognitive computerized test.\n2. Any head trauma, neurodegenerative diseases or CVA after hyperbaric treatment completion.\n3. Diagnosis of a psychiatric disorder including: major depression, schizophrenia, bipolar disorder\n4. Active malignancy\n5. Chronic use of medications that may compromise cognitive function'}, 'identificationModule': {'nctId': 'NCT07430150', 'briefTitle': 'Long Lasting Effect of Hyperbaric Oxygen Therapy on Cognitive Function in Traumatic Brain Injury Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Assaf-Harofeh Medical Center'}, 'officialTitle': 'Long Lasting Effect of Hyperbaric Oxygen Therapy on Cognitive Function in Traumatic Brain Injury Patients', 'orgStudyIdInfo': {'id': '0172-21-ASF'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hyperbaric oxygen therapy (HBOT) active treatment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '70300', 'city': 'Zrifin', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Shai Efrati, Prof', 'role': 'CONTACT', 'email': 'efratishai@outlook.com', 'phone': '972-8-9779393'}], 'facility': 'The Sagol Center for Hyperbaric Medicine and Research Shamir Medical Center (Assaf Harofeh)'}], 'centralContacts': [{'name': 'Shai Efrati, MD', 'role': 'CONTACT', 'email': 'efratishai@outlook.com', 'phone': '972549212866'}], 'overallOfficials': [{'name': 'Shai Efrati, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asaf-Harofhe MC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assaf-Harofeh Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Proffessor', 'investigatorFullName': 'Shay Efrati', 'investigatorAffiliation': 'Assaf-Harofeh Medical Center'}}}}