Clinical trial NCT04149379: Hyperbaric Oxygen Therapy After Stroke - PILOT
Official title: Hyperbaric Oxygen Therapy After Cerebral Infarction - PILOT
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Cerebral Stroke
Keywords: Stroke
Hyperbaric oxygen
Lead sponsor: Norwegian Underwater Intervention (NUI)
Sponsor class: INDUSTRY
Collaborators: name: Western Norway University of Applied Sciences
name: Helse-Bergen HF
First posted: 2019-11-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single subject SSED
Primary purpose: TREATMENT

Brief summary: The goal of this pilot study is to establish more information about hyperbaric oxygen therapy for this group of patients, and give us more information of how to initiate the best possible main study. Can we find any indications that support the use of this therapy for patients suffering from chronic disability after cerebral infarction? Can we improve physical and cognitive function.

Detailed description: This is a pilot project including 6 patients for one session of 20 treatments of hyperbaric oxygen therapy. The objective is to establish knowledge of HBO for this group of patients in a Norwegian context, so that we can prepare for the main study afterwards, including about 60-70 patients. We need to know how to optimize the administrative and technical systems for the larger study. We want to collect feedback from the patients undergoing the pilot study. We want more information about the treatment table, if 20 treatments are enough, if 2,4 bar pressure is adequate. The treatment table is based on existing research, and is considered safe.

The patients are to be treated at table 14/90, at 2,4 Absolute atmospheres, and daly 90 minutes of oxygen inhalation (medical oxygen).

Eligibility criteria: Inlcution criteria:

* No age restriction
* Suffered from ischemic stroke (cerebral infarction) 6-12 months before inclusion.
* Stable phase after standard rehabilitation
* Measurable physical function failure and / or reduced ADL function.
* Sufficient physical function / mobility to be able to move into / out of the pressure chamber with the help of only one person (Tender).

Patients to participate in the study must be physically, mentally and cognitively fit for pressure chamber treatment. They must be able to stand for their own help, move with support, and be able to follow instructions. This is ensured by discretionary assessment after observation and interview with the patient.

Exclusion criteria:

* Claustrophobia
* Psychosis, severe anxiety
* Inability to equalize pressure in the middle ear
* Severe COPD and asthma, pathological lung sounds
* Hypertension (Blood pressure \> 140/90 mmHg)
* Pregnancy
* Hernia
* Earlier fractures, or suspected fractures in the face
* Ongoing chemotherapy
* Previous treatment with Bleomycin
* Aphasia that prevents necessary communication
* Cognitive failure that prevents necessary co-operation in the pressure chamber.
* Previous or current pneumothorax, other lung injury
* Increased risk of pneumothorax

  * Known or suspected injury to the chest
  * Marfan syndrome
  * Homocystinuria
  * Family history of pneumothorax
  * Chronic lung disease (COPD, Emphysema, Asthma eller cystic fibrosis)
  * Tuberculosis

Primary outcomes:
measure: Improved physical and cognitive function in activities of daily living.
timeFrame: 0+6+12 months after end of treatment period
measure: Short Physical Performance Battery (SPPB)
timeFrame: 0+6+12 months after end of treatment period
measure: Grip strength
timeFrame: 0+6+12 months after end of treatment period
measure: Fatigue Severity Scale (FSC)
timeFrame: 0+6+12 months after end of treatment period
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: 0+6+12 months after end of treatment period
measure: Action Research Arm Test (ARAT)
timeFrame: 0+6+12 months after end of treatment period
measure: Nine Hole Peg Test (NHPT)
timeFrame: 0+6+12 months after end of treatment period
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: NUI
state: Hordaland
Study officials:
affiliation: Western Norway University of Applied Sciences
name: Tobba T Südmann, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heyboer M 3rd, Sharma D, Santiago W, McCulloch N. Hyperbaric Oxygen Therapy: Side Effects Defined and Quantified. Adv Wound Care (New Rochelle). 2017 Jun 1;6(6):210-224. doi: 10.1089/wound.2016.0718.
citation: Plafki C, Peters P, Almeling M, Welslau W, Busch R. Complications and side effects of hyperbaric oxygen therapy. Aviat Space Environ Med. 2000 Feb;71(2):119-24.
citation: Mu J, Ostrowski RP, Soejima Y, Rolland WB, Krafft PR, Tang J, Zhang JH. Delayed hyperbaric oxygen therapy induces cell proliferation through stabilization of cAMP responsive element binding protein in the rat model of MCAo-induced ischemic brain injury. Neurobiol Dis. 2013 Mar;51:133-43. doi: 10.1016/j.nbd.2012.11.003. Epub 2012 Nov 10.
citation: Mathieu D, Marroni A, Kot J. Tenth European Consensus Conference on Hyperbaric Medicine: recommendations for accepted and non-accepted clinical indications and practice of hyperbaric oxygen treatment. Diving Hyperb Med. 2017 Mar;47(1):24-32. doi: 10.28920/dhm47.1.24-32.
citation: Al-Waili NS, Butler GJ, Beale J, Abdullah MS, Hamilton RW, Lee BY, Lucus P, Allen MW, Petrillo RL, Carrey Z, Finkelstein M. Hyperbaric oxygen in the treatment of patients with cerebral stroke, brain trauma, and neurologic disease. Adv Ther. 2005 Nov-Dec;22(6):659-78. doi: 10.1007/BF02849960.
citation: Efrati S, Ben-Jacob E. Reflections on the neurotherapeutic effects of hyperbaric oxygen. Expert Rev Neurother. 2014 Mar;14(3):233-6. doi: 10.1586/14737175.2014.884928. Epub 2014 Jan 29.
citation: Rosario ER, Kaplan SE, Khonsari S, Vazquez G, Solanki N, Lane M, Brownell H, Rosenberg SS. The Effect of Hyperbaric Oxygen Therapy on Functional Impairments Caused by Ischemic Stroke. Neurol Res Int. 2018 Oct 9;2018:3172679. doi: 10.1155/2018/3172679. eCollection 2018.
citation: Wang W, Osenbroch P, Skinnes R, Esbensen Y, Bjoras M, Eide L. Mitochondrial DNA integrity is essential for mitochondrial maturation during differentiation of neural stem cells. Stem Cells. 2010 Dec;28(12):2195-204. doi: 10.1002/stem.542.
citation: Efrati S, Fishlev G, Bechor Y, Volkov O, Bergan J, Kliakhandler K, Kamiager I, Gal N, Friedman M, Ben-Jacob E, Golan H. Hyperbaric oxygen induces late neuroplasticity in post stroke patients--randomized, prospective trial. PLoS One. 2013;8(1):e53716. doi: 10.1371/journal.pone.0053716. Epub 2013 Jan 15.
citation: Godman CA, Chheda KP, Hightower LE, Perdrizet G, Shin DG, Giardina C. Hyperbaric oxygen induces a cytoprotective and angiogenic response in human microvascular endothelial cells. Cell Stress Chaperones. 2010 Jul;15(4):431-42. doi: 10.1007/s12192-009-0159-0. Epub 2009 Dec 1.
citation: Vila JF, Balcarce PE, Abiusi GR, Dominguez RO, Pisarello JB. Improvement in motor and cognitive impairment after hyperbaric oxygen therapy in a selected group of patients with cerebrovascular disease: a prospective single-blind controlled trial. Undersea Hyperb Med. 2005 Sep-Oct;32(5):341-9.