N/A
N=19
Cervical Electrical Stimulation for ALS
Amyotrophic Lateral Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT03411863 ↗Enrolled (actual)
19
Serious AEs
5.3%
Results posted
Oct 2022
Primary outcome: Primary: Electromyographic (EMG) Responses (Rest) — 6.8; 21.6; 8.4; -6.1 % change compared to TMS alone
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CES at rest (Device); CES plus active hand or wrist movements (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Electromyographic (EMG) Responses (Rest) |
6.8; 21.6; 8.4; -6.1; 8.0; 3.4 | — |
| PRIMARY Electromyographic Responses (Active) |
— | — |
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.
Eligibility Criteria
Inclusion Criteria (ALS):
- 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
Inclusion Criteria (Participants without neurological disease):
- 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
Exclusion Criteria (ALS):
- 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
- Unsuitable for study participation as determined by study physician
Exclusion Criteria: (Participants without neurological disease)
- 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
- Unsuitable for study participation as determined by study physician
Data sourced from ClinicalTrials.gov (NCT03411863). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.