EMG Triggered Closed-Loop Stimulation for Spinal Cord Injury Individuals

NCT03806023 | Terminated FDA Device

• 1 other identifier: Wu-17-18
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injuries

Keywords

transcutaneous electric nerve stimulation; transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (2)

• Change in motor evoked potential (MEP) amplitude of the abductor pollicis brevis (APB) muscle response to single pulses of TMS

  Assessed pre, then 0, 20, 40, and 60 minutes post-intervention.

• Hand dexterity

  Timed performance on a grooved pegboard task.

  Assessed pre, then 0, 20, 40, and 60 minutes post-intervention.

Secondary Outcomes (3)

• Grip strength

  Assessed pre, then 0, 20, 40, and 60 minutes post-intervention.

• Change in the duration of the 'cortical silent period' after TMS stimulation during APB contraction

  Assessed pre, then 0, 20, 40, and 60 minutes post-intervention.

• F-wave responses of the APB muscle

  Assessed pre, then 0, 20, 40, and 60 minutes post-intervention.

Study Arms (1)

All subjects

EXPERIMENTAL

All subjects undergo same full protocol, including PNS and TMS at rest and active hand movements (signals from thumb muscle) triggered PNS and TMS.

Device: hand movements (signals from thumb muscle) triggered PNS and TMS

Interventions

hand movements (signals from thumb muscle) triggered PNS and TMS DEVICE

PNS, TMS or PNS+TMS will be delivered while the participant performs specific finger tasks at different degrees of effort. This is an experiment designed to detect momentary changes in muscle function.

All subjects

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Bronx VA Medical Center: lead

Study Sites (1)

James J. Peters VA Medical Center

The Bronx, New York, 10468, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Noam Y Harel, MD, PhD

  James J. Peters VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 16, 2019
• Study Start: February 1, 2018
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: October 5, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)