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Behavioural Intervention
Electrical Stimulation for Coma (GCS02 Trial)
N/A
Waitlist Available
Research Sponsored by Markey Olson
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age greater than or equal to 18 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up less than 24 hours
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if using electrical stimulation instead of physical stimulation can help assess the awareness of patients with impaired consciousness. Physical stimulation can cause harm with repeated testing, but electrical stimulation might be safer and
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include skin irritation or discomfort at the site of electrical stimulation. Since this method is being tested, other unexpected side effects might occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ less than 24 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~less than 24 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Comparison of Transcutaneous Stimulation Glascow Coma Scale (Exams) score with traditional SOC
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
10Treatment groups
Experimental Treatment
Group I: Upper Extremity M5Experimental Treatment2 Interventions
Patients with a stable GCS subscore of M5, localizing, in at least one upper limb
Group II: Upper Extremity M4Experimental Treatment2 Interventions
Patients with a stable GCS subscore of M4, withdrawing, in at least one upper limb
Group III: Upper Extremity M3Experimental Treatment2 Interventions
Patients with a stable GCS subscore of M3, flexing, in at least one upper limb
Group IV: Upper Extremity M2Experimental Treatment2 Interventions
Patients with a stable GCS subscore of M2, extending, in at least one upper limb
Group V: Upper Extremity M1Experimental Treatment2 Interventions
Patients with a stable GCS subscore of M1, no response to stimuli, in at least one upper limb
Group VI: Lower Extremity M4Experimental Treatment2 Interventions
Patients with a stable GCS subscore of M4, withdrawing, in at least one lower limb
Group VII: Lower Extremity M3Experimental Treatment2 Interventions
Patients with a stable GCS subscore of M3, flexing, in at least one lower limb
Group VIII: Lower Extremity M1Experimental Treatment2 Interventions
Patients with a stable GCS subscore of M1, no response, in at least one lower limb
Group IX: E2Experimental Treatment2 Interventions
Patients with a stable GCS subscore of E2, eyes opening to pain
Group X: E1Experimental Treatment2 Interventions
Patients with a stable GCS subscore of E2, eyes non-responsive to pain
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcutaneous electrical stimulation
2013
N/A
~240
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Who is running the clinical trial?
Markey OlsonLead Sponsor
Brandon M Fox, MD, PhDStudy DirectorBarrow Neurological Institute