Hyperbaric Oxygen in Patients Who Had a Stroke (HOST)

Hyperbaric Center Basel

Status and phase: Completed; Phase 4

Conditions: Hyperbaric Oxygen; Stroke

Treatments: Drug: Hyperbaric oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT04297358

2017-02131

Details and patient eligibility

About

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

Full description

10 patients having suffered a stroke and having being rehabilitated will be treated with 40 consecutive Hyperbaric Oxygen Treatment (HBOT) after a minimal delay of 3 months after stroke. They will be neurologically assessed before and 3 months after HBOT. Rivermead mobility index will be also assessed.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Stroke patients

Experimental group

Description:

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.

Treatment:

Drug: Hyperbaric oxygen