An Evaluation of Hyperbaric Treatments for Children With Cerebral Palsy
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Purpose
The study is to evaluate the effectiveness of hyperbaric treatments and the potential longer-term effects in children between the ages of 3 and 8 years with spastic cerebral palsy (CP). One group will receive 100% oxygen and the other group will receive the equivalent of 21% oxygen (room air). The children will receive pre-treatment testing (baseline). After 40 experimental treatments are completed, the children will be retested at 0, 3, and 6 months to evaluate any changes.
| Condition | Intervention |
|---|---|
|
Cerebral Palsy Cerebral Palsy, Spastic |
Device: Hyperbaric Oxygen Treatment Device: Hyperbaric Air Treatment |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | An Evaluation of the Therapeutic Effectiveness of Hyperbaric Oxygen Treatments and Hyperbaric Air Treatments for Children With Cerebral Palsy |
- The total change in the score on the Gross Motor Function Measure (GMFM). [ Time Frame: Baseline (pre-treatment) & at 0, 3, and 6 months post-treatment. ] [ Designated as safety issue: Yes ]
- The total change in the score on the Pediatric Evaluation of Disability Inventory (PEDI). [ Time Frame: Baseline (pre-treatment) & at 0, 3, and 6 months post-treatment. ] [ Designated as safety issue: Yes ]
- The total change in the score on the Test of Variables of Attention (TOVA). [ Time Frame: Baseline (pre-treatment) & at 0, 3, and 6 months post-treatment. ] [ Designated as safety issue: Yes ]
| Enrollment: | 49 |
| Study Start Date: | August 2005 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Hyperbaric Oxygen Treatment (HBO) |
Device: Hyperbaric Oxygen Treatment
100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
Other Names:
|
| Active Comparator: Hyperbaric Air Treatment (HBA) |
Device: Hyperbaric Air Treatment
14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
Other Names:
|
Detailed Description:
The study proposed herein is a randomized, double blind study to evaluate the therapeutic effectiveness of HBO in children (ages 3-8 years) with a diagnosis of spastic CP. Ninety-four children will be randomly assigned to either a hyperbaric oxygen treatment group or hyperbaric air treatment (HBA) group. Each group will receive 40 dives of 60 minutes duration each at 1.5 atmospheres of pressure (ATA) (the HBO group receiving 100% oxygen, and the HBA group receiving an air mixture containing 14% oxygen, which simulates 21% oxygen at 1.5 ATA).
Neurological testing (Gross Motor Function Measure, Pediatric Evaluation of Disability Inventory, and the Test of Variables of Attention) will be performed at baseline, immediately after experimental treatment #40, and at 3 and 6 months after experimental treatment #40. Statistical analysis will be performed on these test data to determine any changes from baseline, or between group differences, in the functional capabilities of the study subjects.
Eligibility| Ages Eligible for Study: | 3 Years to 8 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male and female children, ages 3 to 8 years with a diagnosis of spastic cerebral palsy.
- No documented evidence of hypoxic-ischemic encephalopathy (HIE). Hypoxic-ischemic encephalopathy (HIE) is not one of the major causes of CP.
- Medically cleared to participate. Your child's primary care physician will be asked to medically clear your child before entering the study.
- Able to pass pretest screening exercise. Each child will undergo the following screening exercise to determine the likelihood of being able to participate in the study: In order to assess ability to tolerate the placement of the oxygen hood in the hyperbaric setting, a hyperbaric oxygen hood will be placed upon the shoulders, or body of your child (depending upon size of your child) and with encouragement and comforting by you and study nurse, the child will be asked to maintain the placement of the hood for 15 minutes. Each child will be asked to blow through a straw, blow the nose, drink through a straw, or to swallow on command.
Exclusion Criteria:
- Any previous HBO treatments.
- Thoracic surgery within 6 months of beginning the study.
- Unstable epilepsy as determined by a history of having had more than one major motor (generalized or partial tonic/clonic) seizure within the past six months. Having multiple motor seizures, requiring more than three anticonvulsant drugs for seizure control; or requiring changes in seizure medications more than once per month.
- Significant pulmonary dysfunction as determined by a history of chronic pulmonary disease, cystic fibrosis, interstitial lung disease, or chronic shortness of breath or cough. Uncontrolled asthma/reactive airway disease.
- Significant behavioral problems requiring medication.
- Any major congenital deformities of the brain or spinal cord.
- Active pneumothorax (collapsed lung).
- Recent cancer treatment with cisplatinum, bleomycin, or doxorubicin.
- Certain heart problems that cause the heart to pump poorly as determined by a history of congenital heart disease, cardiomyopathy, or symptoms of chest pain, dizziness, and shortness of breath.
- Optic neuritis.
- Diabetics requiring insulin therapy.
- Spherocytosis.
- Major GI reflux with frequent emesis.
- Botulinum toxin A (Botox) treatments within 6 months of entering study.
- Before entering the study, we will require that chronic medications be unchanged for the prior three months except for minor dosage adjustments.
Contacts and Locations| United States, Ohio | |
| Children's Medical Center of Dayton | |
| Dayton, Ohio, United States, 45404-1815 | |
| Wound Healing and Hyperbaric Medicine Center | |
| Wpafb, Ohio, United States, 45433-5546 | |
| Principal Investigator: | Daniel J Lacey, MD PhD | Children's Medical Center of Dayton, Neurologist |
More Information
Additional Information:
Publications:
| Responsible Party: | Children's Medical Center of Dayton |
| ClinicalTrials.gov Identifier: | NCT00290186 History of Changes |
| Other Study ID Numbers: | 03038007, FWP20020014H, DAMD17-03-2-0060, HSRRB-12213, CMC 04-024, KMCN 03-021 |
| Study First Received: | February 8, 2006 |
| Last Updated: | February 26, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Children's Medical Center of Dayton:
|
Cerebral Palsy Spastic Cerebral Palsy CP Hyperbaric HBOT |
Additional relevant MeSH terms:
|
Cerebral Palsy Paralysis Brain Damage, Chronic Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013