Cervical Electrical Stimulation for ALS

NCT03411863 | Completed Results FDA Device

• 1 other identifier: B2527-P
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Veterans are at higher risk than non-Veterans of falling ill with amyotrophic lateral sclerosis (ALS). ALS causes degeneration of motor neurons in both the brain and the spinal cord. Evidence from studies in people with spinal cord injury suggests that activating spared nerve circuits with electromagnetic stimulation improves nerve transmission. With this goal, the investigators have developed a novel method of noninvasive cervical (neck) electrical stimulation (CES). In this study, the investigators will investigate CES for its potential to strengthen nerve circuits to the hands in ALS. To the investigators' knowledge, electrical spinal stimulation for ALS has never been tested previously. This study will be performed in two stages: First, basic experiments will be performed to better understand how CES interacts with other types of electrical and magnetic stimulations over the brain and peripheral nerves. Second, experiments will be performed to determine the types of CES that can facilitate active arm and hand movements. These experiments will improve understanding of electrical stimulation in ALS, and may set the table for future treatments. Both United States Veterans and non-Veterans are eligible to participate in this study.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Transcutaneous Electric Nerve Stimulation; transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (2)

• Electromyographic (EMG) Responses (Rest)

  These results are derived from peak-to-peak EMG amplitude in the abductor pollicis brevis (APB) muscle in response to transcranial magnetic stimulation (TMS). Values represent the ratio of peak-to-peak APB amplitude when TMS is paired with cervical electrical stimulation (CES) at the indicated timing (in milliseconds) normalized to the response to TMS alone (control).

  up to 1 day

• Electromyographic Responses (Active)

  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.

  up to 1 day

Study Arms (2)

Participants without neurological disease

ACTIVE COMPARATOR

Participants without neurological disease. All subjects undergo the same full protocol.

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

Participants with ALS

EXPERIMENTAL

Participants with ALS. All subjects undergo the same full protocol.

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.

Participants with ALS; Participants without neurological disease

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.

Participants with ALS; Participants without neurological disease

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 21 and 75 years
• Diagnosis of probable or definite ALS (or non-disabled volunteer)
• Incomplete weakness of left or right wrist or hand muscles:
• score of 2, 3, or 4 (out of 5) on manual muscle testing of:
• wrist flexion
• finger extension
• finger flexion
• or finger abduction
• Detectable F-wave responses of the left or right abductor pollicis brevis (APB) to median nerve stimulation and/or adductor digiti minimi (ADM) to ulnar nerve stimulation
• US Veteran or non-Veteran
• Age between 21 and 75 years
• No history of significant neurological disease
• Detectable F-wave responses of the left or right APB to median nerve stimulation and/or ADM to ulnar 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
• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Dr. Noam Y. Harel
• Organization: James J. Peters VAMC

noam.harel@va.gov

718-584-9000

Study Officials

• Noam Y. Harel, MD PhD

  James J. Peters Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: January 26, 2018
• Study Start: January 4, 2018
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: October 25, 2022
• Results First Posted: October 25, 2022

Record last verified: 2022-09

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)