Hyperbaric Oxygen Therapy After Stroke - PILOT

NCT04149379 | Withdrawn Phase 2 DMC

• 1 other identifier: 305476
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Stroke

Keywords

Stroke; Hyperbaric oxygen

Outcome Measures

Primary Outcomes (7)

• Improved physical and cognitive function in activities of daily living.

  The project's physiotherapist and ergo therapist from Western Norway University of Applied Sciences (HVL) are responsible for examining physical function and the participant's ability to acquire and use knowledge, as well as function in everyday living activities (ADL). Three measurements are made before starting treatment (establishing a baseline), where the third measurement is done on the same day as treatment starts to eliminate changes in test results as a result of learning the tests. Measurements are also made immediately after the end of treatment, as well as follow-up measurements after 6 and 12 months. Descriptions below.

  0+6+12 months after end of treatment period

• Short Physical Performance Battery (SPPB)

  This test is very widely used to provide a quick and validated test of strength, balance and coordination. The test has a roof effect, so it is not suitable for capturing very small and subtle self-perceived disturbances in function. The test is very sensitive to change in the target group.

  0+6+12 months after end of treatment period

• Grip strength

  There is a recognized and validated connection between general function and health and grip strength, as well as between grip strength and life span. Grip strength changes as other function changes.

  0+6+12 months after end of treatment period

• Fatigue Severity Scale (FSC)

  A major problem after stroke and in many brain disorders is fatigue. Fatigue leads to reduced foxing and thus loss of function. The test is believed to be able to detect changes that are relevant to everyday life function and social participation.

  0+6+12 months after end of treatment period

• Canadian Occupational Performance Measure (COPM)

  COPM is designed to help people identify and prioritize activity problems, as well as evaluate activity performance and satisfaction with activity execution. In an interview, the person is asked to describe activities they consider important but find it difficult to perform. Among the aforementioned challenges, the person is asked to prioritize a maximum of five activities he / she wants to be able to perform better after the end of treatment. Then, the person is asked to score the current performance and satisfaction with the current performance of priority activities. The score scale is from 1-10 where 10 indicates very good workmanship or high satisfaction. After the interview, partial scores for execution (COPM-U) and satisfaction (COPM-T) are calculated. A change score of 3 points is considered a clinically important change. COPM has shown good measurement properties, among other things for participants with stroke and the elderly.

  0+6+12 months after end of treatment period

• Action Research Arm Test (ARAT)

  ARAT is a tool designed to assess motor function in the arm after stroke. The tasks in the test reflect daily activities and the patient's ability to perform them. The test contains 19 sub-tasks in which different grips (five-finger grips, cylinder grips, tweezers grips), as well as gross motor skills are specifically assessed. In each of the 19 tasks, a score is given from 0-3, where high scores indicate good arm function. The total score (0-57) is the sum of the sub-scores. The test has shown promising measurement properties. For participants in the chronic and subacute phase after stroke, a change of 5.7 points (10%) is considered clinically important. Norwegian guidelines will be used in the study.

  0+6+12 months after end of treatment period

• Nine Hole Peg Test (NHPT)

  NHPT is a simple test of fine motor skills that is recommended, among other things, for participants with stroke. Scoring is based on the time the patient spends in placing and removing nine small pieces in nine holes. Total time (maximum 50 seconds) and total number of pins are indicated. The test has shown satisfactory reliability and validity.

  0+6+12 months after end of treatment period

Study Arms (1)

Treatment group

EXPERIMENTAL

One group of 6 patients undergoing 20 sessions of hyperbaric therapy at table 14/90.

Drug: Hyperbaric oxygen

Interventions

Hyperbaric oxygen DRUG

20 sessions of hyperbaric therapy in a pressure chamber at 2,4 absolute atmospheres, 90 minutes per day of breathing 100% medical oxygen through an own mask. Table 14/90.

Treatment group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian Underwater Intervention (NUI): lead
• Western Norway University of Applied Sciences: collaborator
• Helse-Bergen HF: collaborator

Study Sites (1)

NUI

Bergen, Hordaland, 5165, Norway

Location

Related Publications (11)

• 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.

  PMID: 28616361 BACKGROUND

• 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.

  PMID: 10685584 BACKGROUND

• 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.

  PMID: 23146993 BACKGROUND

• 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.

  PMID: 28357821 RESULT

• 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.

  PMID: 16510383 RESULT

• 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.

  PMID: 24471697 RESULT

• 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.

  PMID: 30402285 RESULT

• 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.

  PMID: 20954243 RESULT

• 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.

  PMID: 23335971 RESULT

• 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.

  PMID: 19949909 RESULT

• 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.

  PMID: 16457083 RESULT

Related Links

• The effects of combined hyperbaric oxygen therapy on patients with post-stroke depression

MeSH Terms

Conditions

Stroke

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Tobba T Südmann, PhD

  Western Norway University of Applied Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single subject SSED

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: November 4, 2019
• Study Start: April 20, 2020
• Primary Completion: August 31, 2021
• Study Completion: December 20, 2021
• Last Updated: April 27, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)