Non-invasive Cervical Electrical Stimulation for SCI
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 2/1/2018 |
| Start Date: | August 22, 2017 |
| End Date: | July 31, 2019 |
| Contact: | Sana Saeed, BS |
| Email: | sana.saeed@va.gov |
| Phone: | 718-584-9000 |
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.
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.
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.
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.
Inclusion Criteria:
- Age between 18 and 65 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 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 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
We found this trial at
1
site
Bronx, New York 10468
Principal Investigator: Noam Y. Harel, MD, PhD
Phone: 718-584-9000
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