Hyperbaric Oxygen Therapy: Safety and Efficacy for Concussion

JRCT ID: jRCTs032210243

Registered date:16/08/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Sports-Related Brain Concussion
• Date of first enrollment: 15/04/2022
• Target sample size: 20
• Study type: Interventional
• Intervention(s): All patients will be treated with HBO therapy from Day 1 to Day 3, 115 minutes per day. For the patients who still have symptoms after Day 3, HBO therapy will be added from Day 5 to Day 7.

Outcome(s)

• Primary Outcome: The percentage of cases with serious adverse events or other significant adverse events from baseline to the end of the three days HBO therapy

Secondary Outcome

1) The percentage of patients who were confirmed without concussion syptoms and finished HBO therapy on Day 3
2) The absolute change and percent change of each following SCAT5 score; from baseline to Day 3 (all patients), for patients who recieved 1 course of HBO: from baseline to Day 6-, for patients who recived 2 courses of HBO: from baseline to Day 7 and to Day 10-
SCAT5
STEP 2 (Symptom evaluation): Severity scale
STEP 6 (Concussion decision): Score of orientation, immediate memory, concentration, balance errors, delayed recall
3) For the patients who have pre-concussion results from SCAT5, differences of SCAT5 scores between pre-consussion and Day 3 (all patients), for patients who received 1 course of HBO; between pre-concossion and Day 6-, for patients who received 2 courses of HBO; between pre-concussion and Day 7 and Day 10-
4) For the patients who have pre-concussion results of Eye-tracking test, the change of eye-tracking test results from pre-concussion to Day 3 (all patients), for patients who received 1 course of HBO; from pre-concussion to Day 6-, for patients who received 2 courses of HBO; from pre-concussion to Day 7 and to Day 10-
5) Percentage of patients (over 19 years old) who returned to team practice by Day 7
6) Percentage of patients (over 19 years old) who returned to team practice by Day 11
7) Adverse events observed by Day 12
8) Difference between patients requiring 1 course versus 2 courses of HBO therapy: background, SCAT5 score and eye-tracking results on Day 0/Day 3, and adverse events,
9) Recurrence rate within 1year
10) Number of days required to return to team practice

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) 18 years old and older, both sexes, diagnosed with a consussion at the Teikyo University Sports Medical Science Clinic after receiving impacts to the head, face, neck, or other body parts while playing sports
2) Still showing symptoms of consussion such as headache at a time of visit to the clinic
3) Available for brain MRI or CT at a time of visit to the clinic
4) Able to start HBO therapy within 3 days after the injury
5) Signed written informed consent

Exclude criteria

1) Cases with possible structural damage, such as intracranial hemorrhage, pneumocephalus and inner ear bubbles, on image examinations.
2) Cases with safety concerning symptoms for HBO therapy, such as loss of consciousness or multiple instances of vomiting
3) Cases with disorientation and normal decision making impacted
4) Cases with inner ear injury or those patients who cannot relieve ear pressure
5) Cases with pneumothorax on chest X-ray, untreated pheumothorax, surgical history on the chest, or chronic bronchial athma
6) Cases with history of eye surgery for retinal detachment, or cases being treated with gas applied to their eye's
7) Claustrophobia
8) Pregnant women or possibly pregnant women
9) Cases with nasal obstruction or upper respiratory tract symptoms
10) Cases considered by the investigator or any sub-investigator as inappropriate for this study for any reason

Related Information

• Primary Sponsor: Sasahara Jun
• Source(s) of Monetary Support: Grants-in-Aid for Scientific Research