Non-invasive Cervical Electrical Stimulation for SCI

NCT03414424 | Completed Results FDA Device

• 1 other identifier: HAR-17-017
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injuries

Keywords

transcutaneous electric nerve stimulation; transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (2)

• Electromyographic Responses (Active)

  Effect of cervical electrical stimulation (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.

  up to one day

• Electromyographic Responses to Transcranial Magnetic and Cervical Electrical Stimulation at Rest

  Response of the target hand muscle to transcranial magnetic stimulation (delivered at 120% of resting motor threshold) with or without a conditioning cervical electrical stimulator pulse (delivered at 90% of resting motor threshold) timed to arrive at cervical synapses 2 milliseconds after transcranial pulse arrival. Response is expressed as percentage change relative to the response to unconditioned transcranial magnetic stimulation.

  up to one day

Study Arms (1)

All subjects

EXPERIMENTAL

All subjects undergo same full protocol, including CES at rest and CES plus active hand or wrist movements.

Device: CES at rest; Device: CES plus active hand or wrist movements

Interventions

CES at rest DEVICE

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.

All subjects

CES plus active hand or wrist movements DEVICE

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.

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) 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bronx VA Medical Center: lead

Study Sites (1)

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468, United States

Location

Related Publications (2)

• Wu YK, Levine JM, Wecht JR, Maher MT, LiMonta JM, Saeed S, Santiago TM, Bailey E, Kastuar S, Guber KS, Yung L, Weir JP, Carmel JB, Harel NY. Posteroanterior cervical transcutaneous spinal stimulation targets ventral and dorsal nerve roots. Clin Neurophysiol. 2020 Feb;131(2):451-460. doi: 10.1016/j.clinph.2019.11.056. Epub 2019 Dec 13.

  PMID: 31887616 BACKGROUND

• Wecht JR, Savage WM, Famodimu GO, Mendez GA, Levine JM, Maher MT, Weir JP, Wecht JM, Carmel JB, Wu YK, Harel NY. Posteroanterior Cervical Transcutaneous Spinal Cord Stimulation: Interactions with Cortical and Peripheral Nerve Stimulation. J Clin Med. 2021 Nov 15;10(22):5304. doi: 10.3390/jcm10225304.

  PMID: 34830584 RESULT

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Data collection for the active condition (cervical electrical stimulation during active muscle contraction) was plagued with technical problems, not possible to quantitatively analyze.

Results Point of Contact

• Title: Noam Y. Harel
• Organization: Bronx VA Medical Center

Noam.harel@va.gov

718-584-9000

Study Officials

• Noam Y. Harel, MD, PhD

  Bronx VA Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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 16, 2018
• First Posted: January 30, 2018
• Study Start: August 22, 2017
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: November 29, 2023
• Results First Posted: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: At time of publication
• Access Criteria: A Limited Dataset (LDS) will be shared in electronic format pursuant to a VA-approved Data Use Agreement. Individually Identifiable Data will be shared pursuant to valid HIPAA Authorization, Informed Consent, and an appropriate written agreement limiting use of the data to the conditions as described in the authorization and consent, and a written assurance from the recipient that the information will be maintained in accordance with the security requirements of 38 CFR Part 1.466.

Locations

US (1)