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Electromagnetic Field Treatment
EMF Treatment for Chronic Spinal Cord Injury
N/A
Recruiting
Led By Gabi Zeilig, Ph.D.
Research Sponsored by BrainQ Technologies Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week -1, week 1, week 5, week 9, week 14, week 18, week 22, week 26, week 34
Awards & highlights
Study Summary
This trial will study the effects of the BQ EMF treatment on subjects with chronic SCI who have stable GRASSP scores after a month of physical therapy.
Who is the study for?
This trial is for adults aged 18-75 with chronic cervical incomplete spinal cord injury, stable enough to follow directions and engage in physical therapy. They must have a specific strength score (5-35 on GRASSP) and be able to move their shoulders to a certain degree. Pregnant women or those with severe cognitive issues, drug addiction, excessive pain/spasticity, recent botulinum toxin treatments, epilepsy, or implanted electronic devices cannot participate.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of BQ EMF treatment on patients with chronic spinal cord injuries who are stable after a month of physical therapy. The focus is on whether this electromagnetic field treatment can improve motor functions as measured by the GRASSP strength score.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include discomfort at the site of application or other reactions related to electromagnetic field exposure; however these will be monitored throughout the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week -1, week 1, week 5, week 9, week 14, week 18, week 22, week 26, week 34
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week -1, week 1, week 5, week 9, week 14, week 18, week 22, week 26, week 34
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 of treatment to end of treatment in the Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP - strength subscore)
Secondary outcome measures
Capabilities of the Upper Extremity Test (CUE-T)
GRASSP (sensibility and prehension subscores)
GRASSP (strength subscores)
+6 moreOther outcome measures
Assessment of device's Usability by user (Human factors and usability analysis)
Range of motion (ROM)
Rate of deviation of device user from expected input sequence (Human factors and usability analysis)
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (with PT run-in)Experimental Treatment1 Intervention
Treatment group, to receive BQ treatment with PT, after stability established in 4 week PT run-in period
Find a Location
Who is running the clinical trial?
Sheba Medical CenterOTHER_GOV
724 Previous Clinical Trials
2,840,087 Total Patients Enrolled
BrainQ Technologies Ltd.Lead Sponsor
2 Previous Clinical Trials
128 Total Patients Enrolled
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Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Men and women who are not pregnant and are between 18 and 75 years old.You have struggled with alcohol or drug addiction in the past 5 years, as defined by DSM-IV.You have too much pain in your arm that makes it hard to do the evaluation tests.You have very tight or stiff muscles in your wrist or elbow, as measured by a doctor.You have had Botox injections in the last 4 months or plan to have them during the trial.You have a history of seizures or epilepsy.You have a medical device implanted in your body.You have a spinal cord injury in your neck that is not too severe, and it happened between 12 to 30 months ago.You have a strength score between 5 and 35 on one side of your body.You need to be able to lift your shoulder and move your arm to participate in the study.Women who could become pregnant must have a negative pregnancy test.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (with PT run-in)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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