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Electrical Stimulation Therapy for Nerve Injury After Arm Surgery (PHINEST Trial)

N/A
Recruiting
Led By Amy M Moore, MD
Research Sponsored by Checkpoint Surgical Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing electrical stimulation to help nerves heal & improve recovery after arm surgery. Participants get standard care plus added stimulation.

Who is the study for?
This trial is for adults aged 18-80 with certain types of nerve injuries in the arm, who are candidates for surgery to fix these nerves. They must be able to give consent and not have severe heart issues or other conditions that would prevent surgery.
What is being tested?
The study tests electrical stimulation therapy called Checkpoint BEST System on patients during arm nerve repair surgery. Participants are split into two groups: one receives standard care plus the stimulation, while the control group gets only standard care.
What are the potential side effects?
While specific side effects aren't listed, electrical stimulation may cause discomfort, skin irritation at the site of application, or muscle twitching. Standard surgical risks also apply.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Motor Recovery assessed using the Medical Research Council (MRC) motor grading
Secondary study objectives
2-point discrimination
Electromyography (EMG)
Grip Strength
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Brief Electrical Stimulation TherapyExperimental Treatment1 Intervention
Single, 10 minute dose of electrical stimulation delivered to the injured nerve during surgical intervention.
Group II: Standard of CareActive Control1 Intervention
Surgical intervention for repair of peripheral nerve injury.

Find a Location

Who is running the clinical trial?

Checkpoint Surgical Inc.Lead Sponsor
1 Previous Clinical Trials
100 Total Patients Enrolled
Congressionally Directed Medical Research ProgramsFED
54 Previous Clinical Trials
9,561 Total Patients Enrolled
Amy M Moore, MDPrincipal InvestigatorOhio State University
1 Previous Clinical Trials
100 Total Patients Enrolled

Media Library

Brief Electrical Stimulation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05884125 — N/A
Peripheral Nerve Injury Research Study Groups: Brief Electrical Stimulation Therapy, Standard of Care
Peripheral Nerve Injury Clinical Trial 2023: Brief Electrical Stimulation Therapy Highlights & Side Effects. Trial Name: NCT05884125 — N/A
Brief Electrical Stimulation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05884125 — N/A
~38 spots leftby Jun 2027
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