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

90 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine whether electrical stimulation can be used to replace physical stimulation to test awareness of patients with impaired consciousness. Physical stimulation can cause bruising, damaged nails and ribs, and other damage with repeated testing, and electrical stimulation may be safer and cause less distress with time. This device has not been approved by the U.S. Food and Drug Administration (FDA).

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 data supports the effectiveness of the treatment Electrical Stimulation for Coma?

Research shows that electrical stimulation can help improve outcomes in patients with severe brain injuries by potentially aiding in waking time and recovery. Additionally, similar treatments like functional electrical stimulation have been effective in restoring functions and managing complications in spinal cord injury patients, suggesting potential benefits for coma patients. ^{1 2 3 4 5}

Is electrical stimulation generally safe for humans?

Electrical stimulation, including various forms like transcranial and neuromuscular stimulation, is generally considered safe for humans. Serious side effects are rare, but mild issues like skin burns, headaches, and fatigue can occur. Proper electrode use and skin contact can help prevent burns. ^{4 6 7 8 9}

How does the treatment Transcutaneous Electrical Stimulation for coma differ from other treatments?

Transcutaneous Electrical Stimulation is unique because it uses electrical currents to stimulate nerves and muscles through the skin, potentially restoring lost functions and improving conditions like spasticity and muscle control. Unlike other treatments, it is non-invasive and can enhance neuromuscular function without the need for surgery or medication. ^{2 4 10 11 12}

Research Team

Brandon M Fox, MD, PhD

Principal Investigator

Barrow Neurological Institute

Eligibility Criteria

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

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

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Pilot study of electrical stimulation on median nerve in comatose severe brain injured patients: 3-month outcome. [2014]

2. United States pubmed.ncbi.nlm.nih.gov

Functional electrical stimulation and spinal cord injury. [2021]

3. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Trans-CSF electrostimulation of the brain in patients with posttraumatic vegetative state (theoretical basis and preliminary results)]. [2010]

4. England pubmed.ncbi.nlm.nih.gov

Treatment of spinal spasticity by electrical stimulation. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Electrical muscle stimulation in the intensive care setting: a systematic review. [2018]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. [2023]

7. Brazil pubmed.ncbi.nlm.nih.gov

Safety of neuromuscular electrical stimulation among critically ill patients: systematic review. [2023]

8. England 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. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Burns in functional electric stimulation: two case reports. [2004]

10. Sweden pubmed.ncbi.nlm.nih.gov

Non-invasive neuromuscular electrical stimulation in patients with central nervous system lesions: an educational review. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Enhancement of gait restoration in spinal injured patients by functional electrical stimulation. [2006]

12. Singapore pubmed.ncbi.nlm.nih.gov

Clinical applications of functional electrical stimulation. [2020]