An Evaluation of Hyperbaric Treatments for Children With Cerebral Palsy

NCT00290186 | Terminated Results DMC

• 6 other identifiers: 03038007FWP20020014HDAMD17-03-2-0060HSRRB-12213CMC 04-024KMCN 03-021
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cerebral Palsy; Cerebral Palsy, Spastic

Keywords

Cerebral Palsy; Spastic Cerebral Palsy; CP; Hyperbaric; HBOT

Outcome Measures

Primary Outcomes (1)

• The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Total Score (GMFM-88).

  GMFM-88: total percent score on 88 items (I) of motor function grouped into 5 dimensions: A) lying and rolling (17 I), B) sitting (20 I), C) crawling and kneeling (14 I), D) standing (13 I), E) walking, running, jumping (24 I). Each item scored on 0-3 scale: 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. Scores in each dimension determined by dividing score obtained by maximum possible score for that dimension, and multiplying by 100. Range is 0-100% for each: the higher the percent score, the greater the functional ability. Dimension scores and total GMFM-88 score calculated as: A) lying and rolling: (score achieved/51)x100 B) sitting: (score achieved/60)x100 C) crawling and kneeling: (score achieved/42)x100 D) standing: (score achieved/39)x100 E) walking, running, and jumping: (score achieved/72)x 100 GMFM-88 = (%A+%B+%C+%D+%E)/number of dimensions GMFM-66: \[(total score on subset of 66 items/198)x100\]

  Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)

Secondary Outcomes (16)

• The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure 66-Item Subscale Score (GMFM-66).

  Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)

• The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Dimension A

  Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)

• The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Dimension B

  Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)

• The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Dimension C

  Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)

• The Difference Between Groups (HBO Minus HBA) in Change in Score (Post-treatment Minus Pre-treatment) on Gross Motor Function Measure Dimension D

  Baseline (within 1 week of starting 8-week treatment period) and post-treatment (within 1 week of ending 8-week treatment period)

Study Arms (2)

Hyperbaric Oxygen Treatment (HBO)

EXPERIMENTAL

100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total

Device: Hyperbaric Oxygen Treatment

Hyperbaric Air Treatment (HBA)

ACTIVE COMPARATOR

14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total

Device: Hyperbaric Air Treatment

Interventions

Hyperbaric Oxygen Treatment DEVICE

100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total

Also known as: HBOT, HBO

Hyperbaric Oxygen Treatment (HBO)

Hyperbaric Air Treatment DEVICE

14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total

Also known as: HBAT, HBA

Hyperbaric Air Treatment (HBA)

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dayton Children's Hospital: lead
• United States Department of Defense: collaborator
• Kettering Health Network: collaborator

Study Sites (2)

Dayton Children's Hospital

Dayton, Ohio, 45404-1815, United States

Location

Wound Healing and Hyperbaric Medicine Center

Wpafb, Ohio, 45433-5546, United States

Location

Related Publications (1)

• Lacey DJ, Stolfi A, Pilati LE. Effects of hyperbaric oxygen on motor function in children with cerebral palsy. Ann Neurol. 2012 Nov;72(5):695-703. doi: 10.1002/ana.23681. Epub 2012 Oct 15.

  PMID: 23071074 RESULT

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Daniel J. Lacey, MD, PhD
• Organization: Dayton Children's Hospital

LaceyD@childrensdayton.org

937-641-3080

Study Officials

• Daniel J Lacey, MD, PhD

  Children's Medical Center of Dayton, Neurologist

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2006
• First Posted: February 10, 2006
• Study Start: August 1, 2005
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: August 28, 2014
• Results First Posted: August 28, 2014

Record last verified: 2014-08

Locations

US (2)