Ignite Creation Date:
2025-12-24 @ 2:00 PM
Ignite Modification Date:
2025-12-27 @ 9:13 PM
Study NCT ID:
NCT04360395
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-29
First Post:
2020-04-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Igniting Mobility in Adolescents and Young Adults With Cerebral Palsy
Sponsor:
Father Flanagan's Boys' Home
Organization:
Study Overview
Official Title:
Igniting Mobility in Adolescents and Young Adults With Cerebral Palsy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study design will consist of a cohort of adolescents and young adults with cerebral palsy (CP) that will undergo a gait training protocol. All participants will complete MEG or EEG baseline brain imaging measures of their sensorimotor cortical activity, MRI brain/spinal cord imaging (previous MRI or template brain may be substituted), neurophysiological tests of the spinal cord H-reflex, and a series of mobility clinical tests and cognitive tests. Participants with metal in their body that would interfere with the MEG (e.g., braces on teeth, permanent retainer) will not undergo the MEG tests but will undergo the EEG assessments. Those who complete the MEG assessments will not undergo the EEG assessments.
After completing the baseline tests, the participants with CP will undergo the therapeutic gait training. After completing all of the therapeutic gait training sessions, the participants with CP will repeat the same assessments that were completed at baseline.
Separately, a cohort of neurotypical adolescents and young adults will also complete the baseline assessments. The neurotypical participants will not undergo the therapeutic gait training, but will be used as a normative group for interpreting if the changes seen in the participants with CP after therapy are in fact moving the system toward a normative state.
After completing the baseline tests, the participants with CP will undergo the therapeutic gait training. After completing all of the therapeutic gait training sessions, the participants with CP will repeat the same assessments that were completed at baseline.
Separately, a cohort of neurotypical adolescents and young adults will also complete the baseline assessments. The neurotypical participants will not undergo the therapeutic gait training, but will be used as a normative group for interpreting if the changes seen in the participants with CP after therapy are in fact moving the system toward a normative state.
Detailed Description:
Cerebral palsy (CP) results from a perinatal brain injury and is one of the most prevalent and costly pediatric neurologic conditions in the United States that often results in mobility deficits. The investigator's extensive experimental work has been focused on developing a therapeutic gait training protocol that will improve the long-term mobility of adolescents and young adults with CP. Despite the major breakthroughs, it is apparent across the investigations that some patients have vast improvements in their mobility after treatment, while others are clearly non-responders. This response variability represents one of the major Gordian knots in the treatment outcomes seen in adolescents and young adults with CP. The investigator will address this knowledge gap with a multimodal approach that blends the investigator's expertise in MEG/EEG brain imaging, MRI spinal cord imaging, and assessments of the spinal cord interneuronal circuitry to probe the neurophysiological differences in participants that are classified as responders and non-responders after therapeutic gait training. The Specific Aims of this study will: (1) identify if responders and non-responders have differences in the strength of the sensorimotor cortical oscillations involved in the planning and execution of a leg motor action, (2) determine if responders and non-responders have differences in the neural synchrony within the somatosensory cortices, following stimulation of the foot mechanoreceptors, and (3) decipher if responders and non-responders have differences in the spinal cord microstructure and circuitry dynamics. (4) Secondary aim: assess cognitive related changes induced via physical therapy. Briefly, the study design consists of a cohort of adolescents and young adults with CP that will initially undergo MEG/EEG brain imaging, MRI spinal cord imaging, neurophysiological tests of the spinal cord interneuronal circuitry, cognitive testing, and clinical mobility assessments. After completing the baseline tests, the participants will undergo the therapeutic gait training protocol. Upon completion of the treatment program, the participants will repeat the same assessments that were completed at baseline. Separation of the participants into responders and non-responders to treatment will be based on the criteria for a clinically relevant change in the 10-meter walking speed test. The new data derived from this project will provide unparalleled insight on the potential neurophysiological origins of the diverse mobility outcomes seen in adolescents and young adults with CP after treatment. Finally, an additional cohort of neurotypical adolescents and young adults of similar age and sex will also complete the mobility, MEG/EEG, spinal cord imaging, and Hoffmann reflex protocols for comparative purposes.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: