Hyperbaric Oxygen in Patients Who Had a Stroke

NCT04297358 | Completed Phase 4

• 1 other identifier: 2017-02131
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective clinical assessment of 40 Hyperbaric Oxygen (HBO) treatments in 10 completed stroke patients.

Conditions

Stroke; Hyperbaric Oxygen

Keywords

Hyperbaric Oxygen; Completed Stroke; Feasibility; Prospective

Outcome Measures

Primary Outcomes (7)

• Change in National Institutes of Health Stroke Scale (NIHSS score)

  Neurological assessment before and after HBOT. Composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0 (0 is better).

  Change from Baseline NIHSS Score at 3 months

• Change in Rivermead mobility index (RMI) at 2 weeks

  Mobility scale used in neurological rehabilitation. All items are rated in a yes/no format with positive responses scoring a 1 for a maximal RMI score of 15 (15 is better). Changes are evaluated every two weeks for a total of 8 weeks (every 10 sessions of HBOT), than after 1 and 3 months.

  Change from Baseline RMI at 2 weeks

• Change in Rivermead mobility index (RMI) at 4 weeks

  Mobility scale used in neurological rehabilitation. All items are rated in a yes/no format with positive responses scoring a 1 for a maximal RMI score of 15 (15 is better). Changes are evaluated every two weeks for a total of 8 weeks (every 10 sessions of HBOT), than after 1 and 3 months.

  Change from Baseline RMI at 4 weeks

• Change in Rivermead mobility index (RMI) at 6 weeks

  Mobility scale used in neurological rehabilitation. All items are rated in a yes/no format with positive responses scoring a 1 for a maximal RMI score of 15 (15 is better). Changes are evaluated every two weeks for a total of 8 weeks (every 10 sessions of HBOT), than after 1 and 3 months.

  Change from Baseline RMI at 6 weeks

• Change in Rivermead mobility index (RMI) at 8 weeks

  Mobility scale used in neurological rehabilitation. All items are rated in a yes/no format with positive responses scoring a 1 for a maximal RMI score of 15 (15 is better). Changes are evaluated every two weeks for a total of 8 weeks (every 10 sessions of HBOT), than after 1 and 3 months.

  Change from Baseline RMI at 8 weeks

• Change in Rivermead mobility index (RMI) at 1 month

  Mobility scale used in neurological rehabilitation. All items are rated in a yes/no format with positive responses scoring a 1 for a maximal RMI score of 15 (15 is better). Changes are evaluated every two weeks for a total of 8 weeks (every 10 sessions of HBOT), than after 1 and 3 months.

  Change from Baseline RMI at 1 month

• Change in Rivermead mobility index (RMI) at 3 months

  Mobility scale used in neurological rehabilitation. All items are rated in a yes/no format with positive responses scoring a 1 for a maximal RMI score of 15 (15 is better). Changes are evaluated every two weeks for a total of 8 weeks (every 10 sessions of HBOT), than after 1 and 3 months.

  Change from Baseline RMI at 3 months

Secondary Outcomes (2)

• Tympanic damage

  From date of Start of HBOT until the date of End of HBOT

• Change in Visual Acuity

  Change from Baseline Visual Acuity at 3 months

Study Arms (1)

Stroke patients

EXPERIMENTAL

40 consecutive sessions of hyperbaric oxygen will be administered at a pressure of 2 absolute atmosphere (ATA) to 10 patients. If there are drop outs, recruitment will be continued until a total of 10 patients with at least 30 sessions.

Drug: Hyperbaric oxygen

Interventions

Hyperbaric oxygen DRUG

40 consecutive (5/7) sessions of hyperbaric oxygen

Stroke patients

Eligibility Criteria

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

You may qualify if:

• Patients with ischemic cortical stroke in chronic stage (≥ 3 months) with residual motor deficits confirmed by imaging with brain CT scan and/or brain MRI
• Informed consent

You may not qualify if:

• Neurological issue:
• inability to understand the informed consent form
• Hemiplegia
• Hyperbaric issue:
• Claustrophobia
• inability to put on face mask
• uncontrolled epilepsy
• dementia or psychological disturbance
• previous pneumothorax
• pregnancy

Sponsors & Collaborators

• Hyperbaric Center Basel: lead

Study Sites (1)

Druckkammerzentrum Basel

Basel, 4057, Switzerland

Location

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

• Marco Gelsomino, med pract

  Druckkammerzentrum Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: March 5, 2020
• Study Start: December 20, 2017
• Primary Completion: December 30, 2022
• Study Completion: December 31, 2022
• Last Updated: March 2, 2023

Record last verified: 2023-03

Locations

CH (1)