Recruiting

EMF Treatment

Sponsor:

BrainQ Technologies Ltd.

Code:

NCT04050696

Conditions

Incomplete Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

BQ 1.2

Study Details

Brief summary:

The purpose of this study is to further establish safety and efficacy of the BQ EMF treatment of chronic SCI subjects who demonstrate stability in The Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) strength score following a one-month physical therapy run-in period.

Conditions

Incomplete Spinal Cord Injury

Study ID

NCT04050696

Start date

Sep 18, 2019

Status verified date

Aug, 2023

Completion date

Feb 1, 2024

Anticipated

Primary completion date

Dec 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Males and non-pregnant females who are between 18 to 75 years of age
2. Diagnosed with traumatic or (incident-related) non-traumatic chronic cervical incomplete SCI (AIS B-D), 12 to 30 months from event.
3. Individuals with a score between 5 - 35 on the GRASSP strength subscore on at least one side
4. Medically stable
5. Cognitive status and ability to communicate must be at a level consistent with that which is required to participate in motor rehabilitation regimen (e.g. can follow directions and cued tasks)
6. Stable pharmacological treatment plan without any planned modifications
7. Able to engage in physical therapy program as stipulated per protocol
8. Passive shoulder flexion of at least 60 degrees and passive shoulder abduction of at least 40 degrees, to ensure ability to perform upper limb motor tasks
9. Negative pregnancy test in women of childbearing potential
10. Subject can independently provide consent (written or verbal in the presence of a family member) to participate in the study and is willing to comply with study procedures

Exclusion Criteria:

Subjects not eligible for this study include those that have any of the following:

1. Excessive pain in the UE that limits the administration of the evaluation measurements
2. Excessive spasticity: subjects with MAS of wrist ≥ 2, or MAS of elbow ≥ 3
3. Received botulinum toxin in the previous 4 months, or planning of an upcoming injection during the trial period
4. Participating in any other experimental rehabilitation or drug studies
5. Medical conditions or circumstances that, in the opinion of the investigators, would preclude safe and/or effective participation
6. Severe cognitive or psychiatric problems that might significantly impact the successful study conduct
7. History of epileptic seizures or epilepsy
8. Implanted electronic medical devices
9. Alcoholism or drug addiction as defined by DSM-IV within last 5 years

Study Design

Enrollment

8 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (with PT run-in)

Treatment group, to receive BQ treatment with PT, after stability established in 4 week PT run-in period

Interventions

BQ 1.2

BQ 1.2 exposure of EMF exposure paradigm in conjunction with upper limb PT regimen

Primary outcome measure

  • Change from baseline of treatment to end of treatment in the Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP - strength subscore): [ Time Frame: Week 22 ]

Central Contacts and Locations

Central contacts

Locations

The Miami Project to Cure Paralysis

Recruiting

Miami, Florida, United States, 33136

Contacts

Kessler Institute of Rehabilitation

Recruiting

West Orange, New Jersey, United States, 07052

Contacts

More Information

Sponsor

BrainQ Technologies Ltd.

Last update posted

Aug 22, 2023

Last verified

Aug, 2023

Keywords

  • chronic SCI
  • incomplete SCI
  • central cord syndrome
  • electromagnetic field
  • physical therapy
  • cervical SCI
  • paraplegia
  • tetraplegia
  • upper limb impairment
  • GRASSP
  • ISNCSCI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by BrainQ Technologies Ltd. on 2023-08-22.