EMG Triggered Closed-Loop Stimulation for Spinal Cord Injury Individuals

Stopped early · Not applicable

Conditions studied: Spinal Cord Injuries

In brief

Most individuals with spinal cord injury (SCI) have residual nerve circuits. The investigators aim to strengthen those circuits to improve motor recovery after injury. To do this, the investigators are attempting to pair electrical and magnetic stimulation with physical training targeted toward the connections between nerve circuits. Past studies by other groups have shown that synapse strength can be improved temporarily after a short period of paired stimulation between the brain (motor cortex) and the peripheral nerves serving target muscles - in other words, "Fire Together, Wire Together". The brain's intention to move a muscle can be read by recording surface electrical activity over target muscles (electromyography or EMG). In animal models of SCI, scientists have successfully used target muscle EMG to trigger spinal cord electrical stimulation pulses while the animals perform physical exercises. Using the body's own signals to trigger nerve stimulation is called "closed-loop stimulation". This might be an optimal method to coordinate brain and nerve activity, especially with the clinical advantage of being possible to combine with physical exercise training. However, whether EMG-triggered closed loop stimulation has the same amount of effect when applied non-invasively in humans is still unknown. This proposed study is a proof-of-principle to demonstrate the potential of non-invasive closed-loop stimulation in humans with incomplete cervical SCI. We will test different combinations of triggered and non-triggered electrical and magnetic stimulation, and record the short-term effects on nerve transmission and skilled function of hand muscles. This pilot study will be a foundation for future studies combining EMG-triggered stimulation with long-term physical exercise training.

Key facts

Study ID

NCT03806023

Run by

Bronx VA Medical Center

People needed

8

Starts

2018-02-01

Expected to finish

2020-02-28

Last updated by the study team

2020-10-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age between 18 and 75 years;
• Chronic (more than 12 months since injury) motor-incomplete SCI between neurological levels C2-C8
• Score of 3 or more (out of 5) on manual muscle testing of finger extension, finger flexion, or finger abduction in left or right hand;
• Detectable F-wave responses of the left or right abductor pollicis brevis (APB) to median nerve stimulation;
• Detectable motor evoked potentials in left or right APB;
• Able to perform thumb-middle finger opposition pinch task with detectable APB EMG muscle activity.

You may not qualify if…

• Multiple spinal cord lesions;
• History of seizures;
• Ventilator dependence or patent tracheostomy site;
• Use of medications that significantly lower seizure threshold, such as tricyclic antidepressants, amphetamines, neuroleptics, dalfampridine, and bupropion;
• History of stroke, brain tumor, brain abscess, or multiple sclerosis;
• History of moderate or severe head trauma (loss of consciousness for greater than one hour or 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 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;
• History of suicide attempt;
• Active psychosis;
• Heavy alcohol consumption (greater than equivalent of 5 oz 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.

Where it is running

• James J. Peters VA Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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