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25 Spina Bifida Trials
Power is an online platform that helps thousands of Spina Bifida patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Vibegron for Pediatric Bladder Disorder
Wichita, KansasThe purpose of this study is to evaluate the safety, efficacy, and PK of vibegron in pediatric participants with NDO who are regularly using CIC
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2, 3
Age:2 - 17
Sex:All
Key Eligibility Criteria
Disqualifiers:Cerebral Palsy, Uncontrolled Epilepsy, Others
Must Not Be Taking:Digoxin, Lithium, Others
85 Participants Needed
HIFT for Neurological Disorders
Fort Smith, ArkansasIndividuals with and without neurologic diagnoses greatly benefit from participation in regular exercise but the majority are physically inactive. This is an issue for both them and their care partners as their health is often linked. This study aims to examine the long-term physical and psychosocial effects of structured, group-based, high intensity functional training (HIFT) exercise for people with neurologic diagnoses and their care partners.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Under 18, Non-English Speakers, Others
100 Participants Needed
Transcutaneous Spinal Stimulation for Spina Bifida
Rochester, MinnesotaA study to use transcutaneous spinal cord stimulation to characterize sensorimotor deficits in a pediatric population of individuals with spina bifida.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:5 - 18
Sex:All
30 Participants Needed
Fetoscopic Repair for Spina Bifida
Houston, TexasThis trial is testing a new minimally invasive surgery to fix a spinal defect in unborn babies. The surgery uses tiny tools and cameras inserted through small openings, aiming to reduce risks for both mother and baby. It targets pregnant women whose fetuses have been diagnosed with myelomeningocele (MMC), a severe form of spina bifida. This new treatment technique allows early closure of the spinal defect to prevent potential neurological and psychomotor complications.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1
Age:18 - 64
Sex:Female
60 Participants Needed
Umbilical Cord Patch for Spina Bifida
Houston, TexasThe objective is to test the efficacy of a laparotomy-assisted fetoscopic surgical approach to cover spina bifida spinal cord developmental defects using cryopreserved human umbilical cords (NEOX Cord 1K®) as a meningeal and skin patch.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:Female
Key Eligibility Criteria
Disqualifiers:Diabetes, Hypertension, Obesity, Others
100 Participants Needed
Fetoscopic Umbilical Cord Repair for Spina Bifida
Houston, TexasTo fetoscopically use cryopreserved human umbilical cord allografts, named NEOX Cord 1K®, as a spinal cord cover of spina bifida defects. This procedure will be performed to create a watertight seal covering over the spinal cord in order to decrease the incidence rates of postnatal morbidities. For larger skin defects, NEOX Cord 1K® may be used as a skin cover.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
50 Participants Needed
Surgical Devices for Neural Tube Defects
Houston, TexasThe purpose of the study is to evaluate the safety and efficacy of devices used in patients undergoing fetoscopic neural tube defect repair.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:Female
Key Eligibility Criteria
Disqualifiers:Not Electing For Repair
100 Participants Needed
Incontinence Management Tool for Spina Bifida
Indianapolis, IndianaThis study aims to develop an innovative, interactive tool for joint use by spina bifida patients and their urologists to identify patients interested in addressing their urinary and fecal incontinence and establish continence goal(s) they would like to achieve. To date, no such tool exists for use by spina bifida patients or urologists. This represents a major paradigm shift in the urologic care of pediatric SB patients. It will give children and families a voice in setting their personal goals for urinary and fecal incontinence, rather than relying on physicians' traditional clinical targets (e.g., absence of urinary incontinence, 4-hour dry interval). These traditional views fail to reflect the full patient experience of their ailment by underestimating symptoms and prioritizing only the most severe. This study represents the first time that such a process will be formalized before initiating urological therapy in children with SB (Aim 2). Additionally, this tool may help rule out interventions with a low chance of achieving desired goals and allow for a recalibration of unrealistic goals. The app will be useful for any child, regardless of urinary and fecal incontinence treatment history or underlying bladder pathology, as it will help describe personalized clinical treatment goals based on urinary incontinence, a characteristic all these patients share. This study will also capture the health-related quality of life (HRQOL) impact of urinary and fecal incontinence improvement regardless of the treatment, whether behavioral, medical or surgical, many of which are available to patients regardless of age. A systematic therapeutic goal-setting tool will help in bringing precision medicine to the SB population.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:8+
Sex:All
67 Participants Needed
Exercise Training for Cerebral Palsy
Birmingham, AlabamaThe purpose of this research study is to test the feasibility and response of a new exercise protocol on improving physical activity in adolescents with cerebral palsy.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:11 - 21
Sex:All
Key Eligibility Criteria
Disqualifiers:Orthopedic Surgery, Botulinum Toxin, Heart, Others
36 Participants Needed
Movement-2-Music Exercise Program for Mobility Disabilities
Birmingham, AlabamaThe purpose of this study is to test the effects of an innovative exercise program referred to as movement-2-music (M2M) on health and fitness outcomes in adults with physical/mobility disabilities. One hundred and eight participants with physical/mobility disabilities will be recruited and randomly enrolled into one of two groups: a) M2M or b) waitlist control. The primary aim of this study is to determine the effects of a 12-week M2M program on health and fitness in participants with physical/mobility disabilities who are in one of three functional mobility groups: 1) Group I - only able to exercise while sitting, 2) Group II - able to exercise sitting and standing with/without support, and 3) Group III - able to exercise one side of the body more than the other side. The second aim is to compare the observed effects of the program in this study to a previous M2M study that groups participants based on disability type. The third aim of this study is to test whether adherence (defined as attendance to the 12-week program) affects the effects of M2M in participants with physical/mobility disabilities. The potential influences of different functional mobility and disabilities of participants on how the program affects participants' health and fitness outcomes will also be tested.
\*\*In response to COVID-19, the 12-week M2M intervention and all assessments have been modified from being delivered in-person at Lakeshore Foundation to being delivered remotely in real-time through videoconferencing technology.\*\*
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18 - 70
Sex:All
108 Participants Needed
Wheelchair Skills Training for Mobility Impairments
Grand Rapids, MichiganThis trial tests a training program called Skills on Wheels, which helps children with physical disabilities learn to use manual wheelchairs on their own. The goal is to make them more confident and safe in using their wheelchairs, and to improve their social skills and participation in activities.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:5 - 17
Sex:All
4 Participants Needed
Wellness Programs for Disabilities
Pittsburgh, PennsylvaniaPeople with disabilities experience a staggering incidence of secondary conditions that can result in death or negatively impact their health, participation in the community, and quality of life. Many of these chronic secondary conditions are preventable. The Institute for Healthcare Improvement has advocated for optimizing care through programs that simultaneously improve health and the patient experience of care, while reducing cost, called the "Triple Aim." Studies have shown that the Triple Aim can be achieved through programs that facilitate community integration; however the U.S. healthcare system lacks a paradigm of care for individuals with disabilities that promotes community integration. In order to identify potential models of healthcare delivery for individuals with disabilities that are effective in achieving the Triple Aim, we will conduct a rigorous research project to evaluate the impact of two different models of care on the Triple Aim: 1) a community-based care management program delivered by a non-profit organization through waiver funds, and 2) the Program for All-inclusive Care for the Elderly (PACE) applied to younger individuals with disabilities between ages 55-64.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Age:7+
Sex:All
130 Participants Needed
MHealth System for Chronic Health Conditions
Pittsburgh, PennsylvaniaThis study will assess the benefits of using mobile health system designed for individuals with chronic and complex health conditions (such as those with Spinal Cord Injury,Cerebral Palsy, Spina Bifida, and Traumatic Brain Injury) to improve their wellness and self-management skills compared to those who receive standard of care only.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:12+
Sex:All
Key Eligibility Criteria
Disqualifiers:Severe Intellectual Disability, Psychiatric Illness, Others
160 Participants Needed
Digital vs Traditional Ankle Foot Orthoses for Muscular Weakness
Mississauga, OntarioThe research is being done to compare two methods of creating AFOs: 1. The traditional method, which involves manually creating a mold from a plaster cast of the client's limb. This is time-consuming and labor-intensive; and 2. The newer method uses digital technology, such as 3D scanning and printing, to design and produce the AFOs, potentially making the process faster and less costly. We want to know whether AFOs made using digital technology can provide the same clinical benefits as those made traditionally.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:8+
Sex:All
50 Participants Needed
Robotic Walking Device for Child Movement Disorders
Bethesda, MarylandThis trial tests a robotic exoskeleton that helps children with walking difficulties due to conditions like cerebral palsy or spinal cord injury. The device can either assist or challenge their walking to strengthen muscles and improve movement. Children will use the exoskeleton in different settings to see if it improves their ability to walk. Robotic exoskeletons have been increasingly used in pediatric rehabilitation to assist children with cerebral palsy in improving their walking abilities.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:3 - 17
Sex:All
Key Eligibility Criteria
Disqualifiers:Uncontrolled Seizures, Pregnancy, Others
44 Participants Needed
Knee-Ankle-Foot Brace for Cerebral Palsy
Bethesda, MarylandBackground:
- Cerebral palsy (CP) is the most common motor disorder in children. CP often causes crouch gait, an abnormal way of walking. Knee crouch has many causes, so no single device or approach works best for everybody. This study s adjustable brace provides many types of walking assistance. Researchers will evaluate brace options to find the best solution for each participant, and whether one solution works best for the group.
Objective:
- To evaluate a new brace to improve crouch gait in children with CP.
Eligibility:
* Children 5 17 years old with CP.
* Healthy volunteers 5 17 years old.
Design:
* All participants will be screened with medical history and physical exam.
* Healthy volunteers will have 1 visit. They will do motion analysis, EMG, and EEG described below.
* Participants with CP will have 6 visits.
* Visit 1:
\<TAB\>1. Motion analysis: Balls will be taped to participants skin. This helps cameras follow their movement.
\<TAB\>2. EMG: Metal discs will be taped to participants skin. They measure electrical muscle activity.
\<TAB\>3. Participants knee movement will be tested.
\<TAB\>4. Participants will walk 50 meters.
\<TAB\>5. Participants legs will be cast to make custom braces.
* Visit 2:
* Participants will wear their new braces and have them adjusted.
* Steps 1 3 will be repeated.
* EEG: Small metal discs will be placed on the participants scalp. They record brain waves.
* Participants will have electrical stimulation of their knees and practice extending them.
* Participants will take several walks with the braces in different settings.
* Visits 3 5: participants will repeat the walking and some other steps from visit 2.
* Visit 6 will repeat visit 2.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:5 - 100
Sex:All
Key Eligibility Criteria
Disqualifiers:Seizure History, Pregnancy, Others
85 Participants Needed
Standing Program for Spina Bifida
San Diego, CaliforniaThe purpose of this single-subject study is to investigate children with spinal bifida who have significant knee limitations in lower extremity passive range of motion to answer the following research questions:
1. Is a home standing program effective in reducing lower extremity passive range of motion limitations in children with Spina Bifida?
2. Does a home standing program change the quality of functional movement in children with spina bifida?
3. Does a home standing program change a child's performance in daily activities, mobility, and social/cognitive domains?
4. Does a home standing program change a child's health-related quality of life in children with spinal bifida?
5. Does a home standing program result in a change in gait velocity in children with Spina Bifida?
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:5 - 12
Sex:All
Key Eligibility Criteria
Disqualifiers:Non-MMC SB, Hoffer Level 5, Others
12 Participants Needed
Fetoscopic Repair for Spina Bifida
Baltimore, MarylandThe purpose of this investigation is to evaluate maternal and fetal outcomes following fetoscopic repair of fetal spina bifida at the Johns Hopkins Hospital.
The hypothesis of this study is that fetoscopic spina bifida repair is feasible and has the same effectiveness as open repair of fetal spina bifida, but with the benefit of significantly lower maternal and fetal complication rates. The fetal benefit of the procedure will be the prenatal repair of spina bifida. The maternal benefit of fetoscopic spina bifida repair will be the avoidance of a large uterine incision. This type of incision increases the risk of uterine rupture and requires that all future deliveries are by cesarean section. The use of the minimally invasive fetoscopic surgical technique may also lower the risk of preterm premature rupture of membranes and preterm birth compared to open fetal surgery. Finally, successful fetoscopic spina bifida repair also makes vaginal delivery possible.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18 - 50
Sex:Female
30 Participants Needed
In-Utero Surgery Techniques for Spina Bifida
Pasadena, CaliforniaThe purpose of this study is to evaluate the feasibility and effectiveness of performing fetoscopic surgical correction of fetal spina bifida. Two surgical approaches will be utilized: the percutaneous technique versus the laparotomy/uterine exteriorization technique.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 52
Sex:Female
Key Eligibility Criteria
Disqualifiers:Multiple Gestation, Diabetes, Obesity, Hypertension, Others
110 Participants Needed
Fetoscopic Surgery for Spina Bifida
Los Angeles, CaliforniaThe purpose of this study is to evaluate the feasibility of a fetoscopic surgical technique for antenatal correction of fetal myelomeningocele. Two surgical approaches will be utilized. The percutaneous approach will be offered to participants with a posterior placenta. The laparotomy/uterine exteriorization approach will be offered to participants regardless of placental location.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:Female
Key Eligibility Criteria
Disqualifiers:Diabetes, Obesity, Hypertension, HIV, Others
12 Participants Needed
Stem Cell Therapy for Spina Bifida
Sacramento, CaliforniaSpina bifida, or myelomeningocele (MMC), is a birth defect that results in paralysis, excess fluid on the brain (hydrocephalus), and impaired ability to urinate and have bowel movements normally. In a previous study (the MOMS trial), surgery before birth (in-utero/fetal surgery) was shown to reduce the need for shunting for hydrocephalus. There was also some improvement in ambulation, but 58 % of the children still could not walk unassisted.
This study is testing living stem cells from placenta added to the fetal repair in an effort to improve the ability to walk. Previous animal studies have shown dramatic improvement in walking and bowel and bladder function when placental stem cells are added to MMC repair. Use of these "living" cells may protect the developing spinal cord, prevent further injury, and may even reverse existing damage to the nerves that control movement. This study is assessing the safety and efficacy of adding stem cells to open fetal surgery for MMC in humans.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:19 - 25
Sex:All
Key Eligibility Criteria
Disqualifiers:Multifetal Pregnancy, Diabetes, Obesity, Hypertension, Others
55 Participants Needed
Surgical Sectioning for Tethered Cord Syndrome
New York, New YorkThis trial is testing whether a surgery to cut a small piece of tissue at the end of the spinal cord is better than standard medical treatments for patients with Occult Tethered Cord Syndrome (OTCS). These patients often do not find relief from typical treatments. The surgery aims to relieve pressure and tension in the spinal cord, which may help improve their symptoms. This surgical method is currently the most widely accepted treatment for OTCS.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:2 - 80
Sex:All
Key Eligibility Criteria
Disqualifiers:Radiographic Tethered Cord, Prior Lumbar Surgery, CNS Infection, Others
20 Participants Needed
PREP Intervention for Youth with Physical Disabilities
Montreal, QuebecThe goal of this clinical trial is to learn about how a participation-based intervention builds capacity of youth with physical disabilities to pursue activities of their choice in the community. The investigators plan to examine in what ways working with a therapist to set up and engage in an 8-week self-chosen community-based activity builds capacity of youth with physical disabilities to pursue a new activity of their choice in the community without the support of a therapist.
During this study, participants will be followed for 26 weeks. Youth will work with an occupational therapist (OT).
* In the first week, the OT will meet with youth to set a community-based leisure goal. Examples of activities could include music, sports, cooking lessons, painting, or photography, in the youth's community.
* The OT will work with youth to identify and remove barriers. They will also adapt the activity to help youth do the activity for 8 weeks. During this time, the OT will perform site visits to consult and support youths' involvement as needed. (Weeks #1-8)
* Youth will have a four-week break after completing their first activity. (Weeks #9-12). Then, youth will be asked to choose a second (new) activity. They will try to start this activity for 8 weeks without the OT. (Weeks #13-20)
* At the end of these 8 weeks, the same therapist will help the youth for 6 weeks if needed to do their second activity. (Weeks #21-26)
Youth will be asked to complete the following online:
1. A standard demographic questionnaire (during the first meeting).
2. Rate their perceived performance in the chosen activity once a week.
3. A questionnaire about their daily participation in the community. This will be done at the start and end of the study.
4. A questionnaire about how well they feel they are able to do things. This will be done three times.
5. Share steps they take to participate in the activity. This will be done through a weekly diary entry. In addition, three one-on-one interviews (for about an hour each) will be done remotely (using Microsoft TEAMS) to share their experience pursuing their selected activities. Interviews will be done before starting their second (new) activity, after 8 weeks of pursuing the new activity on their own, and after 6 weeks with OT support. These interviews will be video, and audio recorded and transcribed.
This study examines 'real-life' experiences and participation outcomes of youth with physical disabilities after a participation-based capacity-building intervention.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:15 - 24
Sex:All
10 Participants Needed
Community-Based Activity Program for Physical Disabilities
Montreal, QuebecParticipation in community-based activities is essential to the health and well-being of youth with physical disabilities; yet, it is extremely restricted. Emerging treatment approaches aimed at improving participation have shifted from focusing only on impaired body functions towards the performance of functional meaningful activities within the youth's natural environment. Investigators' initial results from studies in Quebec show that targeting intervention at the activity/participation level can result in improvement of impaired body functions (e.g., balance, attention, anxiety) - important components to address in rehabilitation. Investigators' team aims to continue studying the impact of participation by launching a larger more rigorous study. Investigators have partnered with major organizations providing rehabilitation services for youth as well as key community-based stakeholders including youth, clinicians, and managers, and together investigators plan to further examine whether engaging in an 8-week community-based activity individually chosen by the youth (e.g., sledge hockey, drawing, playing a musical instrument) can lead to a significant improvement in three key body functions: motor, behavioral and emotional. One hundred and fifty youth with physical disabilities living in Quebec and Ontario will participate and engage in an activity of choice. Changes in their body functions (e.g., movement, attention, mood) will be measured multiple times before, during and after engagement in the chosen activity. Findings of this study can guide clinicians, families and policy-makers to select effective approaches that not only promote participation but also facilitate additional motor and mental benefits from a single intervention. Such 'real-world' treatment approaches involving activities of choice can also increase motivation, compliance and reduce burden on the healthcare system and on the youth and families.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:12 - 18
Sex:All
150 Participants Needed
Fetoscopic Repair Techniques for Spina Bifida
Houston, TexasThe purpose of the study is to compare the maternal, fetal and neonatal outcomes of a cohort of 60 patients in whom a multilayer closure with a Durepair patch is performed with a prior cohort of patients in whom a standardized repair without patch (n = 32) was performed using the same minimally invasive fetoscopic repair technique.
The hypothesis is that there will be a thicker repair (as measured by MRI at 6 weeks post surgery) and less MMC repair dehiscence and/or CSF leak with the patch repair.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1
Age:18 - 64
Sex:Female
38 Participants Needed
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Frequently Asked Questions
How much do Spina Bifida clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Spina Bifida clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Spina Bifida trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Spina Bifida is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Spina Bifida medical study ?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Spina Bifida clinical trials ?
Most recently, we added Transcutaneous Spinal Stimulation for Spina Bifida, Digital vs Traditional Ankle Foot Orthoses for Muscular Weakness and Community-Based Activity Program for Physical Disabilities to the Power online platform.