Non-invasive Cervical Electrical Stimulation for SCI
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03414424|
Recruitment Status : Active, not recruiting
First Posted : January 30, 2018
Last Update Posted : April 6, 2020
Most spinal cord injuries 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.
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries||Device: CES at rest Device: CES plus active hand or wrist movements||Not Applicable|
Roughly 60% of spinal cord injuries occur at the cervical level. Most injuries are anatomically incomplete. Activating spared nerve circuits augments functional recovery of the damaged nervous system. With this goal, the Investigators have developed a novel method of non-invasive cervical electrical stimulation (CES). Preliminary data show that CES triggers afferent sensory or efferent motor nerve roots depending on stimulus intensity, resulting in concurrent activation of multiple muscles on both upper limbs. the Investigators aim 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.
However, much more work needs to be done to better understand underlying CES mechanisms, its interactions with segmental and supraspinal circuits, and its optimal stimulation parameters for improving neural transmission to the hands. This proposal will address these issues.
Mechanistic experiments: 15 able-bodied volunteers and 15 subjects with motor-incomplete cervical spinal cord injury will undergo systematic combinations of CES with transcranial magnetic stimulation or peripheral nerve stimuli at varying intensities, sites, and interstimulus intervals.
Mechanistic hypotheses: Conditioning subthreshold CES pulses will potentiate responses to test pulses of TMS and peripheral nerve F-wave stimulation, will reduce responses to test pulses of peripheral nerve H-reflex stimulation, and will modulate response to test suprathreshold CES pulses in either direction depending on conditioning stimulus interval and intensity. These experiments will elucidate CES circuit interactions at both the segmental and supraspinal levels.
Combined CES-volitional movement experiments: 15 able-bodied volunteers and 15 subjects with motor-incomplete cervical spinal cord injury will undergo systematic combinations of CES with volitional wrist and hand movements at varying intensity and effort level.
Combined CES-volitional movement hypotheses: Conditioning subthreshold CES pulses will facilitate concurrent volitional wrist and hand muscle activation. Suprathreshold CES will transiently inhibit concurrent volitional wrist and hand muscle activation. These experiments will shed light on the clinically relevant possibility of using CES to enhance response to physical exercise therapy.
Completion of the proposed studies will characterize CES circuit timing and distribution, and will demonstrate in principle the potential for CES to enhance physical therapy for wrist and hand muscles. Furthermore, this approach is compatible with other interventions, including drug and cell-based treatments.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Non-invasive Cervical Electrical Stimulation for SCI|
|Actual Study Start Date :||August 22, 2017|
|Estimated Primary Completion Date :||July 31, 2020|
|Estimated Study Completion Date :||July 31, 2020|
Experimental: All subjects
All subjects undergo same full protocol, including CES at rest and CES plus active hand or wrist movements.
Device: CES at rest
CES will be delivered at rest at various intensities, in combination with either electrical stimulation over peripheral nerves or magnetic stimulation over the motor cortex.
This is an experiment designed to measure CES interactions with other central and peripheral nerve circuits.
Device: CES plus active hand or wrist movements
CES will be delivered while the participant performs specific finger or wrist tasks at different degrees of effort.
This is an experiment designed to detect momentary changes in muscle function.
- Electromyographic responses (rest) [ Time Frame: up to one day ]Response to electrical and magnetic stimulation, singly or in combination, will be measured via peak-to-peak amplitude (millivolts) in first dorsal interosseous and abductor pollicis brevis muscles of conditioned relative to non-conditioned stimuli.
- Electromyographic responses (active) [ Time Frame: up to one day ]Effect of CES on concurrent finger or wrist active movements will be measured via root-mean-square of ongoing muscle activity in various hand and forearm muscles.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03414424
|United States, New York|
|James J. Peters VA Medical Center, Bronx, NY|
|Bronx, New York, United States, 10468|
|Principal Investigator:||Noam Y. Harel, MD, PhD||Bronx VA Medical Center|