N/A
N=30
Non-invasive Cervical Electrical Stimulation for SCI
Spinal Cord Injuries
Bottom Line
View on ClinicalTrials.gov: NCT03414424 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Electromyographic Responses (Active)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CES at rest (Device); CES plus active hand or wrist movements (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bronx VA Medical Center
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Electromyographic Responses (Active) |
— | — |
| PRIMARY Electromyographic Responses to Transcranial Magnetic and Cervical Electrical Stimulation at Rest |
6.1; 32.0 | — |
Summary
Most spinal cord injuries (SCI) are anatomically incomplete - some nerve circuits remain intact, even if the individual cannot feel or control them. Activating spared nerve circuits may improve functional recovery.
With this goal, the Investigators have developed a form of electrical stimulation over the cervical spinal cord that can activate muscles in both hands simultaneously and comfortably. This technique, called cervical electrical stimulation (CES), works at the skin surface - no surgery or other invasive procedures are required.
The long-term goal is to use CES to strengthen residual circuits to hand muscles after SCI. Regaining control over hand function represents the top priority for individuals with cervical SCI.
In the current study, the Investigators first need to better understand how CES works. In the first half of this study, the Investigators will take a systematic approach to determining how CES interacts with other circuits in the spinal cord and the brain. In the second half of the study, the Investigators will test combinations of CES with active hand and wrist movements to find ways to enhance physical movement with CES.
These experiments will improve understanding of electrical stimulation in SCI, and may set the table for future treatments to prolong any short-term benefits observed in this study.
Eligibility Criteria
Inclusion Criteria
- Age between 18 and 75 years;
- Chronic (more than 12 months since injury) incomplete SCI between levels C2-C8.
- Incomplete weakness of left or right hand muscles: score of 2, 3, or 4 (out of 5) on manual muscle testing of finger extension, finger flexion, or finger abduction;
- Detectable F-wave responses of the left or right abductor pollicis brevis muscle to median nerve stimulation.
- US Veteran or non-Veteran
Exclusion Criteria
- History of other serious injury or disease of central or peripheral nervous system
- History of seizures
- Ventilator dependence or patent tracheostomy site
- Use of medications that significantly lower seizure threshold
- History of head trauma with evidence of brain contusion or hemorrhage or depressed skull fracture on prior imaging
- History of implanted:
- brain/spine/nerve stimulators
- aneurysm clips
- ferromagnetic metallic implants
- or cardiac pacemaker/defibrillator
- Significant coronary artery or cardiac conduction disease
- Recent history (within past 6 months) of recurrent autonomic dysreflexia, defined as a syndrome of sudden rise in systolic pressure greater than 20 mm Hg (millimeters of mercury) or diastolic pressure greater than 10 mm Hg, without rise in heart rate, accompanied by symptoms such as headache, facial flushing, sweating, nasal congestion, and blurry vision (this will be closely monitored during all screening and testing procedures);
- History of bipolar disorder or suicide attempt or active psychosis
- Heavy alcohol consumption (> equivalent of 5 ounces of liquor) within previous 48 hours
- Open skin lesions over the face, neck, shoulders, or arms
- Pregnancy
- Unsuitable for study participation as determined by study physician
Data sourced from ClinicalTrials.gov (NCT03414424). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.