Hyperbaric Oxygen and Manipulative Therapies to Regain Function Post Stroke

NCT03352232 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: 14-063
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

To study safety, feasibility and outcomes of combining osteopathic manipulative therapies with hyperbaric oxygen therapy in reducing the functional deficits in stroke survivors in subacute and chronic phases post ischemic stroke. To document the same as part of a pilot project in anticipation of further investigational studies.

Conditions

Stroke; Motor Dysfunction; Chronic Stroke; Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• National Institute of Health Stroke Score (NIHSS) 0-5 or Modified Rankin Score (mRS) 0-2

  Primary Outcome NIHSS 0-5, 0 without deficits; mRS 0-2, 0 without disability - 2 slight disability, no need for assistance

  90 Days

Secondary Outcomes (5)

• Beck Depression Inventory

  90 days

• Wolf Motor Score

  90 days

• Rivermead Extended Activities of Daily Living (EADL) scale

  90 days

• Medical Outcomes 36 Item

  90 days

• Functional Independence Measure (FIM)

  90 days

Study Arms (2)

Subacute Ischemic Stroke

EXPERIMENTAL

Subacute stroke patients post stroke within 3 months of enrollment, have persistent neurological deficits despite conventional rehabilitation

Combination Product: HBOT and OMT

Chronic Ischemic Stroke

EXPERIMENTAL

Chronic stroke patients more than 6 months from stroke with persistent neurological deficits despite conventional rehabilitation

Combination Product: HBOT and OMT

Interventions

HBOT and OMT COMBINATION_PRODUCT

Hyperbaric oxygen therapy (HBOT) is defined as breathing 100% oxygen at increased atmospheric pressure. Osteopathic manipulative therapy (OMT) is used for myriad ailments including contractures, pain, spasticity. Patients in intervention arms will receive hyperbaric oxygen therapy at 2ATM (atmospheres) for 90minutes daily for up to 6weeks. In addition, they will receive osteopathic manipulative therapies twice a week during the same treatment phase.

Also known as: Osteopathic manipulative therapies (OMT), Hyperbaric Oxygen Therapy (HBOT)

Chronic Ischemic Stroke; Subacute Ischemic Stroke

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Post Ischemic stroke
• Patients aged 18-80
• NIHSS \>5
• mRS\>/=3, which connotes moderate disability requiring some help.
• Persistent significant motor dysfunction of at least one arm
• Subacute stroke patients (within three months from time of stroke)
• Chronic stroke patients (more than 6months from time of stroke)
• Patient must be able to understand instructions and verbalize discomfort
• Reliable attendance for daily (M-F) HBOT treatment and 2x/week OMT sessions for up to 6weeks

You may not qualify if:

• Hemorrhagic stroke
• Prior functional disability mRS \>1
• Expressive or receptive aphasia
• Bedbound patients due to lifting limitations for HBOT
• History of severe, advanced emphysema with bullous disease
• Prior history of spontaneous pneumothorax or chest surgery
• Prior history of depression requiring medications
• Pregnancy
• Concomitant non-conventional rehab therapies including: acupuncture, botulinum toxin injections, massage therapy
• Significant claustrophobia

Sponsors & Collaborators

• Abington Memorial Hospital: lead
• Philadelphia College of Osteopathic Medicine: collaborator

Study Sites (1)

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

MeSH Terms

Conditions

Stroke; Neurologic Manifestations; Ischemic Stroke

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Hana Choe, MD

  Abington Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Director NeuroIntervention and Neurocritical Care

Model Details: There will be two populations based on when they experienced a stroke. Subacute stroke patients will have suffered an ischemic stroke within 3 months of enrollment and have persistent neurological deficits. The second group will be patients who suffered an ischemic stroke more than 6 months (chronic) from time of enrollment and have persistent neurological deficits compromising activities of daily living.

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: November 24, 2017
• Study Start: February 3, 2018
• Primary Completion: July 19, 2021
• Study Completion: July 19, 2021
• Last Updated: December 21, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)