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Non-Invasive Spinal Cord Stimulation for Neurological Disorders

N/A
Recruiting
Led By Katherine M Steele, PhD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Volunteers who can read and speak English
Patients able to attend up to 5 sessions per week of physical therapy and testing activities
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 10 months.
Awards & highlights

Study Summary

This trial will study whether non-invasive stimulation of the spinal cord can improve walking function for people with neurologic conditions.

Who is the study for?
This trial is for people with neurological conditions like cerebral palsy who can walk 20 yards and follow simple instructions. They must be medically stable, able to attend up to five therapy sessions weekly, and have support for the 11-month study period. Those with severe medical issues, uncontrolled seizures, recent musculoskeletal surgeries, or implanted devices are excluded.Check my eligibility
What is being tested?
The study tests if non-invasive spinal stimulation combined with gait training improves walking in neurologic conditions. It's a cross-over design where participants first get only training or training plus stimulation, then switch after a break period. Each phase lasts up to 8 weeks with follow-ups for three months.See study design
What are the potential side effects?
Potential side effects of transcutaneous spinal stimulation may include discomfort at the site of stimulation, muscle spasms, skin irritation from electrode placement, and fatigue due to increased physical activity during gait training.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can read and speak English.
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I can attend up to 5 physical therapy sessions weekly.
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My health condition is stable.
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I can follow simple instructions and perform basic tasks.
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I have a condition that affects my nervous system.
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I can walk 20 yards with or without help.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 10 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 10 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline - Six Minute Walk Test
Change from baseline - Ten Meter Walk Test
Secondary outcome measures
Change from baseline - Electromyography recording of lower extremity muscles
Change from baseline - Gait Outcomes Assessment List
Change from baseline - Kinetic and kinematic gait analysis using three dimensional camera system
+3 more

Trial Design

2Treatment groups
Active Control
Group I: Intensive Training OnlyActive Control1 Intervention
Physical and gait training that targets rehabilitation of walking function.
Group II: Intensive Training Combined with Spinal StimulationActive Control2 Interventions
Transcutaneous spinal stimulation combined with physical and gait training that targets rehabilitation of walking function.

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,732 Previous Clinical Trials
1,842,094 Total Patients Enrolled
10 Trials studying Cerebral Palsy
1,184 Patients Enrolled for Cerebral Palsy
Seattle Children's HospitalOTHER
299 Previous Clinical Trials
5,216,789 Total Patients Enrolled
7 Trials studying Cerebral Palsy
211 Patients Enrolled for Cerebral Palsy
Katherine M Steele, PhDPrincipal InvestigatorUniversity of Washington
2 Previous Clinical Trials
91 Total Patients Enrolled
2 Trials studying Cerebral Palsy
91 Patients Enrolled for Cerebral Palsy

Media Library

Cerebral Palsy Clinical Trial 2023: Gait Training Highlights & Side Effects. Trial Name: NCT04467437 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are senior citizens being included in the research protocol?

"As stated in the eligibility requirements, individuals aged 10 and over but not exceeding 70 may apply to participate."

Answered by AI

What criteria must be met for one to take part in this medical experiment?

"An individual must have cerebral palsy, a specified age range of 10-70, and meet other requirements to be eligible for this clinical trial. We expect to take on roughly 20 patients in total."

Answered by AI

How many individuals are involved in the current experiment?

"Yes, according to clinicaltrials.gov the trial is actively recruiting patients with a start date of January 1st 2021 and most recently updated on November 14th 2022. It aims to enrol 20 participants from one medical centre."

Answered by AI

Are there any recruitment opportunities currently available for this research project?

"Confirmative, the information hosted on clinicaltrials.gov reflects that this medical trial is actively enrolling participants. The research was initially posted on January 1st 2021 and has been modified as late as November 14th 2022. 20 patients have to be enrolled from a single centre."

Answered by AI

What are the primary goals of this experiment?

"The principal objective of this examination, to be monitored over a period spanning 10 months and involving baseline readings followed by bi-weekly data collection, is to assess the alteration from the initial state in terms of Six Minute Walk Test performance. Further outcomes will consider changes concerning kinetic and kinematic gait analysis with three dimensional camera systems that measure joint angle (in degrees) and velocity (metres per second), electromyography recordings of lower limb muscles (recorded in microvolts), as well as Patient-Reported Outcome Measurement Information System Pediatric Profile metrics such as depression, anxiety, physical function/mobility, pain interference,"

Answered by AI
~2 spots leftby Aug 2024