NCT04297358 - Hyperbaric Oxygen in Patients Who Had a Stroke | Crick

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Enrollment

10

Conditions

Stroke Hyperbaric Oxygen

Interventions

Hyperbaric oxygenDRUG

40 consecutive (5/7) sessions of hyperbaric oxygen

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Druckkammerzentrum Basel

Basel, Switzerland

Outcomes

Primary Outcomes

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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Hyperbaric Oxygen in Patients Who Had a Stroke

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes