Cerebral Palsy Clinical Trial
Official title:
Metformin for Motor and Cognitive Improvement in Children With Cerebral Palsy: A Feasibility Study
The study design is a single-subject ABA clinical trial that is investigating the feasibility including adherence, safety and tolerability of metformin in children aged 5 to 18 years with cerebral palsy (CP). ABA refers to Phase A1 with no metformin, Phase B with metformin, and Phase A2 with no metformin. Secondarily, the study is exploring whether metformin has possible health benefits for improving motor function and cognition.
The trial is designed as a 48 week limited institution two-site single case ABA study feasibility trial. ABA refers to Phase A1 with no metformin, Phase B with metformin, and Phase A2 with no metformin. Primary endpoints are feasibility, including recruitment, adherence to study medication and outcome measure completion, safety and tolerability of metformin. Key secondary endpoints are gross motor function and sustainability of intervention. Exploratory endpoints are cognitive and MRI measures as well as qualitative information regarding barriers to participation. All participants will receive the study drug (metformin) during the 16 week intervention period. This study will be done at two different locations in Toronto 1) Holland Bloorview Kids Rehabilitation Hospital and 2) the Hospital for Sick Children (SickKids). Each participant will be asked to go to both hospitals to do different tests and assessments for the study. Ten participants with physician diagnosis of CP age 5 to 18 with evidence of white matter imaging (WMI) or Grey Matter Imaging (GMI), and gross motor function classification system (GMFCS) levels II-V will be recruited for participation. MRI, cognitive testing and focus groups will be conducted at SickKids where paediatric protocols and processes have been developed. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05317234 -
Genetic Predisposition in Cerebral Palsy
|
N/A | |
| Recruiting |
NCT05576948 -
Natural History of Cerebral Palsy Prospective Study
|
||
| Completed |
NCT04119063 -
Evaluating Wearable Robotic Assistance on Gait
|
Early Phase 1 | |
| Completed |
NCT03264339 -
The Small Step Program - Early Intervention for Children With High Risk of Developing Cerebral Palsy
|
N/A | |
| Completed |
NCT05551364 -
Usability and Effectiveness of the ATLAS2030 Exoskeleton in Children With Cerebral Palsy
|
N/A | |
| Completed |
NCT03902886 -
Independent Walking Onset of Children With Cerebral Palsy
|
||
| Recruiting |
NCT05571033 -
Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy
|
N/A | |
| Not yet recruiting |
NCT04081675 -
Compliance in Children With Cerebral Palsy Supplied With AFOs
|
||
| Completed |
NCT02167022 -
Intense Physiotherapies to Improve Function in Young Children With Cerebral Palsy
|
N/A | |
| Completed |
NCT04012125 -
The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy
|
N/A | |
| Enrolling by invitation |
NCT05619211 -
Piloting Movement-to-Music With Arm-based Sprint-Intensity Interval Training Among Children With Physical Disabilities
|
Phase 1 | |
| Completed |
NCT04489498 -
Comparison of Somatometric Characteristics Between Cerebral Palsy and Normal Children, Cross-sectional, Multi Center Study
|
||
| Completed |
NCT03677193 -
Biofeedback-enhanced Interactive Computer-play for Youth With Cerebral Palsy
|
N/A | |
| Recruiting |
NCT06450158 -
Robot-assisted Training in Children With CP
|
N/A | |
| Completed |
NCT04093180 -
Intensive Neurorehabilitation for Cerebral Palsy
|
N/A | |
| Completed |
NCT02909127 -
The Pediatric Eating Assessment Tool
|
||
| Not yet recruiting |
NCT06377982 -
Human Umbilical Cord Blood Infusion in Patients With Cerebral Palsy
|
Phase 1 | |
| Not yet recruiting |
NCT06007885 -
Examining Capacity Building of Youth With Physical Disabilities to Pursue Participation Following the PREP Intervention.
|
N/A | |
| Not yet recruiting |
NCT03183427 -
Corpus Callosum Size in Patients With Pineal Cyst
|
N/A | |
| Active, not recruiting |
NCT03078621 -
Bone Marrow-Derived Stem Cell Transplantation for the Treatment of Cerebral Palsy
|
Phase 1/Phase 2 |