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

No Placebo-Only Group

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and week -1, week 1, week 5, week 9, week 14, week 18, week 22, week 26, week 34 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline of treatment to end of treatment in the Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP - strength subscore)

Secondary study objectives

Capabilities of the Upper Extremity Test (CUE-T)

GRASSP (sensibility and prehension subscores)

GRASSP (strength subscores)

+6 more

Other study objectives

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 more