The Use of Electromagnetic Field (EMF) Treatment in Chronic Spinal Cord Injury (SCI) Patients

Technology
Arm/hand function
Online since 8 November 2021, updated 870 days ago

About this trial

This is a trial to test the safety and efficacy of a brain stimulation device called BrainQ (BQ) on upper limb function, spasticity, pain, and overall quality of life in persons with chronic incomplete cervical-level spinal cord injury. The BQ device delivers low levels of an electromagnetic field, non-invasively through the skull, to stimulate the nerves that control the muscles of the weakened upper limb. If included, participants will receive 4 weeks of physical therapy alone without BQ stimulation and then be reassessed. If they continue to qualify after testing, they will undergo 18 additional weeks of physical therapy in combination with BQ. Functional testing will be performed at the beginning of the trial and then at weeks 1, 5, 9, 14, 18, 22, 26, and 34. Magnetic resonance imaging will be performed at weeks 5 and 22.

Included participants

Gender
All
Age
18 - 75 years
Injury level
C1 - C8
  • Severity (AIS)?
  • AIS-B
    AIS-C
    AIS-D
    Time since injury
    12 months - 30 months
  • Injury type
  • Traumatic

    Non-traumatic

    Ischemia

    Healthy volunteers
    No
    C1-C8
    Additionally, participants must
    have a spinal cord injury for 12-30 months.
    have a neurological level of injury between C1 and C8.
    have one of the following ASIA impairment scale (AIS):

    What’s involved

    Type

    Technology

    Details

    4 weeks of physical therapy alone followed by 18 weeks of physical therapy in combination with BQ device stimulation. Functional testing will be performed at weeks 1, 5, 9, 14, 18, 22, 26, and 34. Magnetic resonance imaging will be performed at weeks 5 and 22.

    Potential benefits

    Main benefits

    Arm/hand function

    Additional benefits

    General health

    Mental health

    Pain

    Spasticity

    Standing/walking/mobility

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more

    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 18 Sep 2019
    • Organisation
    • BrainQ Technologies Ltd.
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 18 Sep 2019
    • Organisation
    • BrainQ Technologies Ltd.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more