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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
PHINEST Trial 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.Check my eligibility
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.See study design
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.
PHINEST Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-surgery, 2 months, 4 months, 6 months, 8 months, 10 months, 12 months, 15 months, and 18 months
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Motor Recovery assessed using the Medical Research Council (MRC) motor grading
Secondary outcome measures
2-point discrimination
Electromyography (EMG)
Grip Strength
+6 morePHINEST 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.
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Who is running the clinical trial?
Checkpoint Surgical Inc.Lead Sponsor
1 Previous Clinical Trials
100 Total Patients Enrolled
1 Trials studying Nerve Injury
100 Patients Enrolled for Nerve Injury
Congressionally Directed Medical Research ProgramsFED
48 Previous Clinical Trials
6,716 Total Patients Enrolled
1 Trials studying Nerve Injury
100 Patients Enrolled for Nerve Injury
Amy M Moore, MDPrincipal InvestigatorOhio State University
1 Previous Clinical Trials
100 Total Patients Enrolled
1 Trials studying Nerve Injury
100 Patients Enrolled for Nerve Injury
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a serious health condition like heart failure that prevents me from having surgery.I have a nerve injury in my arm between my shoulder and wrist.I am younger than 18 or older than 80.My nerve reconstruction surgery was over a year ago.I am a candidate for surgery to repair a nerve by transferring, stitching, or grafting.I am between 18 and 80 years old.My surgery needed a graft larger than 6cm.I am eligible for surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Brief Electrical Stimulation Therapy
- Group 2: Standard of Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any restrictions on who can participate in this research?
"To be accepted into this research, a participant must suffer from peripheral nerve injury and fit within the age group of 18-80. 60 participants are being sought after in total."
Answered by AI
Is there still availability for participants in this clinical investigation?
"The clinicaltrials.gov listing indicates that this trial is no longer actively seeking participants, having been initially posted on June 1st 2023 and last edited 30 days prior to now. Although the recruitment for this particular study has ended, there are 797 other trials with open enrollment currently active."
Answered by AI
Is enrollment open for individuals aged 85 and older in this research project?
"This trial is open to those aged 18-80, with 131 children's trials and 642 geriatric studies available for potential participants outside of this age range."
Answered by AI
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