CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 19 enrolled
Drug / intervention
CES at rest +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03411863
NCT03411863N/ACompleted

Noninvasive Cervical Electrical Stimulation for ALS: Mechanistic and Safety Study

VA Office of Research and Development·interventional·Posted Jan 26, 2018·Updated Oct 25, 2022

In Brief

A clinical study evaluating CES at rest and CES plus active hand or wrist movements for Amyotrophic Lateral Sclerosis. Completed, enrolled 19 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJan 26, 2018
Enrollment StartJan 4, 2018
Primary CompletionJun 1, 2021
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 8.4 years ago

Interventions

CES at restdevice

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.

CES plus active hand or wrist movementsdevice

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.