Metformin for Motor and Cognitive Improvement in Children with Cerebral Palsy: A Feasibility Study
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Has your child been diagnosed with cerebral palsy? Your child may be eligible to participate in a study that will investigate the effectiveness of a medication called metformin, and whether it helps to improve your child’s movement and thinking skills.
We want to conduct a small study to see if it would be possible to do a bigger study that would test the effectiveness of a drug called metformin, and whether it helps improve motor skills (i.e. controlled body movements) and thinking skills in children with cerebral palsy (CP), when taken for 16 weeks. All participants will receive metformin. This study will take place at two different places in Toronto: 1) Holland Bloorview Kids Rehabilitation Hospital (Holland Bloorview) and 2) the Hospital for Sick Children (SickKids).
- Darcy Fehlings, MD (Holland Bloorview Kids Rehabilitation Hospital, Toronto, ON)
- Donald J. Mabbott, PhD (The Hospital for Sick Children, Toronto, ON)
Who can participate
We are looking for children with cerebral palsy between 5-18 years old who:
- Gross Motor Function Classification Scale (GMFCS) level II- V
- Able to consume tablets whole or crushed, orally or through a gastrostomy tube
- Able to communicate (verbal or non-verbal) pain or discomfort
- Have not had orthopedic surgery in the past six months
- Have no treatment or planned treatment involving diuretics
- Have not been part of another clinical intervention in the past three months
- Other safety criteria
- CHILD BRIGHT Network – funded by the Canadian Institutes of Health Research (CIHR)
- The Hospital for Sick Children Foundation
- Holland Bloorview Kids Rehabilitation Hospital Foundation
- Three to Be Foundation
This is a 48 week (11 month) study that will take place at Holland Bloorview and SickKids. The study involves a screening visit, an observation period of 16-months before metformin is started, a baseline visit, a 16 week intervention period where metformin is taken, along with a follow-up visit about 4 months later. You and your child will first be asked to come in for a screening session; through talking with you and your child and completing some assessments, we will determine if your child meets the eligibility criteria.
There will be 10 study visits at Holland Bloorview and 3 study visits at SickKids. If willing, your child will also have 2 pictures of their brain taken at SickKids. Furthermore, your child will complete thinking tests 3 times at SickKids.
Participants will be reimbursed for parking and/or TTC expenses for each study visit to Holland Bloorview and/or SickKids. Participants will also receive a $100 gift card three times throughout the study in recognition of their time commitment.
Interested in participating?
If you are interested in participating in this study or have additional questions, please contact Eisha Amjad at 416-425-6220 ext. 6211 or firstname.lastname@example.org. Contacting us does not obligate you or your child to participate in the study.