Electrical Stimulation for Coma

(GCS02 Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Markey Olson

Disqualifiers: Neurologic decline, Pacemaker, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if electrical stimulation can safely test awareness in people with impaired consciousness, such as those in a coma, instead of physical stimulation, which may cause bruises or other harm. Researchers will use transcutaneous (through the skin) electrical stimulation to assess its long-term safety and stress levels. Individuals in a coma admitted to a specific neuro ICU, with a representative able to provide consent, might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance care for those with impaired consciousness.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this device is safe for patients with impaired consciousness?

Research has shown that electrical stimulation on the skin is generally safe. One study safely used it with patients who had spinal cord injuries. Another study found it helped reduce muscle weakness in patients with brain injuries, indicating good tolerance.

Although the FDA has not approved this treatment for the specific purpose of this study, it has shown promising safety results in other conditions. Participants in past studies typically handled the stimulation well without major issues. This suggests the treatment might be a safer option than physical methods for testing patient awareness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of transcutaneous electrical stimulation for coma patients because it offers a non-invasive method to potentially improve neurological responses. Unlike traditional approaches like medication or passive monitoring, this technique directly stimulates nerves through the skin, aiming to enhance brain activity and responsiveness without the risks associated with more invasive procedures. This method could provide quicker feedback on patient progress, offering a promising avenue for improving outcomes in coma recovery.

What evidence suggests that this device is effective for testing awareness in patients with impaired consciousness?

This trial will explore Transcutaneous Electrical Stimulation, which applies small electrical currents to the skin, to assist patients with consciousness issues. Studies have shown that this method can help individuals with spinal cord injuries by reducing muscle stiffness and improving movement through gentle nerve stimulation. Research indicates that this technique can safely assess awareness in patients without causing physical harm, such as bruises or nail damage. Early findings suggest that electrical stimulation might be a safer and less stressful option compared to physical methods. Although still under study, these initial results are promising for improving patient care. ^{1 3 6 7 8}

Who Is on the Research Team?

Brandon M Fox, MD, PhD

Principal Investigator

Barrow Neurological Institute

Are You a Good Fit for This Trial?

This trial is for individuals with Type 1 Diabetes who are in a coma. It's designed to see if electrical stimulation can be used instead of physical touch when checking patient awareness using the Glasgow Coma Scale.

Inclusion Criteria

Patient is admitted to the Barrow Neurological Institute's neuro ICU

Patient is in a comatose state, defined as non-responsive with a GCS eye or motor response sub-score that requires noxious stimulation

I have someone who can make decisions for me about joining a study.

Exclusion Criteria

Presence of an implantable or external pacemaker currently in use

Prisoners

Neurologic decline immediately prior to study participation requiring urgent or emergent workup or management

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Phase 1

Non-invasive electrical stimulation is applied to measure response at one time point

Less than 24 hours

1 visit (in-person)

Phase 2

Non-invasive electrical stimulation is applied to measure response at two separate time points approximately 2 hours apart

Less than 24 hours

1 visit (in-person)

Follow-up

Participants are monitored for any unexpected changes in vital signs during the study

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous Electrical Stimulation

Trial Overview

The study compares transcutaneous electrical stimulation (not yet FDA-approved) against standard physical methods to assess consciousness in comatose patients, aiming to find a safer and less distressing alternative.

How Is the Trial Designed?

Group I: Upper Extremity M5 Experimental Treatment 2 Interventions

Patients with a stable GCS subscore of M5, localizing, in at least one upper limb

Group II: Upper Extremity M4 Experimental Treatment 2 Interventions

Patients with a stable GCS subscore of M4, withdrawing, in at least one upper limb

Group III: Upper Extremity M3 Experimental Treatment 2 Interventions

Patients with a stable GCS subscore of M3, flexing, in at least one upper limb

Group IV: Upper Extremity M2 Experimental Treatment 2 Interventions

Patients with a stable GCS subscore of M2, extending, in at least one upper limb

Group V: Upper Extremity M1 Experimental Treatment 2 Interventions

Patients with a stable GCS subscore of M1, no response to stimuli, in at least one upper limb

Group VI: Lower Extremity M4 Experimental Treatment 2 Interventions

Patients with a stable GCS subscore of M4, withdrawing, in at least one lower limb

Group VII: Lower Extremity M3 Experimental Treatment 2 Interventions

Patients with a stable GCS subscore of M3, flexing, in at least one lower limb

Group VIII: Lower Extremity M1 Experimental Treatment 2 Interventions

Patients with a stable GCS subscore of M1, no response, in at least one lower limb

Group IX: E2 Experimental Treatment 2 Interventions

Patients with a stable GCS subscore of E2, eyes opening to pain

Group X: E1 Experimental Treatment 2 Interventions

Patients with a stable GCS subscore of E2, eyes non-responsive to pain

Transcutaneous Electrical Stimulation is already approved in United States, European Union for the following indications:

Approved in United States as Transcutaneous Electrical Stimulation for:

• Paralysis or paresis due to spinal cord injury or stroke
• Paralysis or paresis due to other brain or nerve injuries

Approved in European Union as Transcutaneous Electrical Stimulation for:

• Spinal cord injury rehabilitation
• Neuromuscular rehabilitation

Who Is Running the Clinical Trial?

Markey Olson

Lead Sponsor

Trials

1

Recruited

90+

Published Research Related to This Trial

Functional Electrical Stimulation (FES) effectively restores controlled muscle contractions and limb function in patients with severe upper motor neuron lesions, particularly benefiting spinal cord injury patients.

To enhance patient acceptance and usability, future advancements in electrode technology and the development of 'close-loop' systems for better control and activation are necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical applications of functional electrical stimulation. Kumar, VP., Lau, HK., Liu, J., et al.[2020]

Hybrid High-Intensity Interval Training (HIIT) using Functional Electrical Stimulation (FES) was found to be safe and well-accepted by participants with spinal cord injuries, with no serious adverse events reported during the 8-week study involving 8 participants.

Participants experienced a significant 17% increase in peak oxygen uptake (VO2peak) and reported improvements in leisure time physical activity and quality of life, indicating that this training method can enhance physical fitness and overall well-being for individuals with SCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hybrid high-intensity interval training using functional electrical stimulation leg cycling and arm ski ergometer for people with spinal cord injuries: a feasibility study. Vestergaard, M., Jensen, K., Juul-Kristensen, B.[2022]

Transcutaneous electrical stimulation in 44 patients with spinal cord injuries significantly reduced spasticity and improved both passive and active movement, as well as respiratory function.

The treatment also restored normal blood pressure and neurogenic bladder functions, indicating a broad range of benefits beyond just spasticity reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of spinal spasticity by electrical stimulation. Franek, A., Turczynski, B., Opara, J.[2019]

All 50 spinal cord injury patients with lesions from T4-T12 were able to stand using functional electrical stimulation (FES), demonstrating its efficacy in restoring standing ability.

Out of the 50 patients, 25 were able to walk with FES, but after three months of home use, only 16 continued to walk due to challenges in adapting to the FES system and its operational demands.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancement of gait restoration in spinal injured patients by functional electrical stimulation. Kralj, A., Bajd, T., Turk, R.[2006]

Low intensity transcranial electrical stimulation (TES) is considered safe, with no serious adverse events reported in over 18,000 sessions across various populations, including healthy individuals and patients with neurological or psychiatric conditions.

While moderate adverse events like skin burns from tDCS are rare, mild adverse events such as headaches and fatigue are more common, and the safety profile is consistent across different age groups and vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Antal, A., Alekseichuk, I., Bikson, M., et al.[2023]

Transcutaneous electrical stimulation can effectively improve muscle strength, motor control, and reduce spasticity in patients with upper motor neurone lesions, enhancing their overall functional condition.

Combining neuromuscular electrical stimulation with treatments like botulinum toxin and exercise therapy may provide additional benefits, although the current evidence is limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive neuromuscular electrical stimulation in patients with central nervous system lesions: an educational review. Schuhfried, O., Crevenna, R., Fialka-Moser, V., et al.[2022]

Electric stimulation is commonly used for diagnosis and therapy in spinal cord injury patients, but it can lead to tissue burns, as demonstrated in two reported cases.

To prevent burns during electric stimulation, it is crucial to use electrodes with a large surface area, ensure uniform contact with the skin, maintain a good conducting interface, provide adequate ventilation for heat dissipation, and avoid sharp electrode corners or damaged wires.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Burns in functional electric stimulation: two case reports. Balmaseda, MT., Fatehi, MT., Koozekanani, SH., et al.[2004]

Citations

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We aimed to determine whether right median nerve electrical stimulation is a safe and effective treatment for accelerating emergence from coma ...

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NMES applied daily for fourteen consecutive days reduced muscle atrophy, the incidence of NED, and muscle weakness in critically ill TBI patients.