Electrical Stimulation Therapy for Nerve Injury After Arm Surgery
(PHINEST Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byAmy M Moore, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Checkpoint Surgical Inc.
Disqualifiers: Arrhythmia, Congestive heart failure, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This study is evaluating a new therapeutic use of electrical stimulation to promote nerve healing and improve functional recovery following surgical intervention for peripheral nerve injury in arm. Participants will be randomized into one of two groups, treatment or control, with all participants receiving standard of care treatment for the nerve injury. The treatment group will also receive a single dose of the therapeutic stimulation during the surgical intervention for their nerve injury.
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 for nerve injury after arm surgery?
Research shows that Percutaneous Electrical Nerve Stimulation (PENS) and Transcutaneous Electrical Nerve Stimulation (TENS) have been effective in managing pain and aiding nerve regeneration in various conditions. These therapies use electrical currents to stimulate nerves, which can help reduce pain and promote healing.
12345Is electrical stimulation therapy generally safe for humans?
Transcutaneous electrical nerve stimulation (TENS) is widely used for pain relief in various conditions and is considered safe for most people. It is a noninvasive method that delivers electrical currents through the skin to activate nerves, and while evidence on its effectiveness can be inconclusive, safety concerns are minimal.
45678How does electrical stimulation therapy differ from other treatments for nerve injury after arm surgery?
Electrical stimulation therapy is unique because it uses low-frequency electrical currents to enhance nerve regeneration and functional recovery, which is not typically achieved with standard surgical treatments. This therapy can accelerate axon growth and improve nerve function, offering a novel approach compared to traditional methods that often result in incomplete recovery.
29101112Eligibility Criteria
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.Inclusion Criteria
I have a nerve injury in my arm between my shoulder and wrist.
Signed and dated informed consent form
I am a candidate for surgery to repair a nerve by transferring, stitching, or grafting.
+2 more
Exclusion Criteria
I have a serious health condition like heart failure that prevents me from having surgery.
All contraindications to included/required surgical procedure, including but not limited to language barriers, mental status barriers, inability to consent, and pregnancy/lactation
I am younger than 18 or older than 80.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Surgical Intervention
Participants undergo surgical intervention for peripheral nerve injury, with the treatment group receiving a single 10-minute dose of electrical stimulation
Single day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at multiple time points up to 18 months
18 months
Multiple visits (in-person and virtual)
Participant Groups
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.
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 Clinic Near You
Research Locations NearbySelect from list below to view details:
The Ohio State Univeristy - Department of Plastic and Reconstructive SurgeryColumbus, OH
Northwestern Feinberg School of Medicine - Department of Orthopaedic SurgeryChicago, IL
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Who Is Running the Clinical Trial?
Checkpoint Surgical Inc.Lead Sponsor
Congressionally Directed Medical Research ProgramsCollaborator
References
Randomized double-blind sham-controlled crossover study of short-term effect of percutaneous electrical nerve stimulation in neuropathic pain. [2011]Percutaneous electrical nerve stimulation (PENS) is an electrical neuromodulation technique that has shown its therapeutic potential in various chronic pain conditions over the past few years, but well-blinded controlled studies are lacking.
Transcutaneous Electrical Nerve Stimulation in Nerve Regeneration: A Systematic Review of In Vivo Animal Model Studies. [2022]Transcutaneous electrical nerve stimulation (TENS) is a noninvasive electrical stimulation therapy indicated for pain control that has been applied for the regeneration of nerves. This systematic review aimed to analyze the evidence on TENS effectiveness on nerve regeneration.
Skin impedance is not a factor in transcutaneous electrical nerve stimulation effectiveness. [2022]Transcutaneous electrical nerve stimulation (TENS) is a nonpharmacological intervention used to manage pain using skin surface electrodes. Optimal electrode placement is unclear. We hypothesized that better analgesia would occur if electrodes were placed over sites with lower skin impedance. Optimal site selection (OSS) and sham site selection (SSS) electrode sites on the forearm were identified using a standard clinical technique.
Percutaneous Versus Transcutaneous Electrical Nerve Stimulation for the Treatment of Musculoskeletal Pain. A Systematic Review and Meta-Analysis. [2022]The justification for this review is the need for high-quality evidence to assist in the decision-making process when applying percutaneous electrical nerve stimulation (PENS) or transcutaneous electrical nerve stimulation (TENS) in a clinical setting. The main aim was to determine if the use of PENS is more effective and should be recommended when compared to TENS for the reduction of musculoskeletal pain intensity.
Patient-Administered Transcutaneous Electrical Nerve Stimulation for Postoperative Pain Control After Laparoscopic Cholecystectomy: A Randomized, Sham-Controlled Feasibility Trial. [2022]Transcutaneous electrical nerve stimulation (TENS) is a noninvasive analgesic neurostimulation modality. Difficulties in clinical trial blinding and therapy administration have limited conclusions of previous trials. The aims of this study were to first investigate the feasibility and acceptability of patient-administered TENS after surgery, and second, the feasibility of using sub-sensory TENS as a proxy sham group for patient-blinding.
Transcutaneous electrical nerve stimulation for advanced cancer pain inpatients in specialist palliative care-a blinded, randomized, sham-controlled pilot cross-over trial. [2021]Transcutaneous electrical nerve stimulation (TENS) is a treatment option for cancer pain, but the evidence is inconclusive. We aimed to evaluate the efficacy and safety of TENS.
Transcutaneous electrical nerve stimulation (TENS) for chronic pain. [2018]Transcutaneous electrical nerve stimulation (TENS) is used in a variety of different clinical settings to treat a range of different acute and chronic pain conditions and has become popular with both patients and health professionals.
Transcutaneous Electrical Nerve Stimulation (TENS) A Possible Aid for Pain Relief in Developing Countries? [2021]Transcutaneous electrical nerve stimulation (TENS) refers to the delivery of electrical currents through the skin to activate peripheral nerves. The technique is widely used in developed countries to relieve a wide range of acute and chronic pain conditions, including pain resulting from cancer and its treatment. There are many systematic reviews on TENS although evidence is often inconclusive because of shortcomings in randomised control trials methodology. In this overview the basic science behind TENS will be discussed, the evidence of its effectiveness in specific clinical conditions analysed and a case for its use in pain management in developing countries will be made.
Brief Electrical Stimulation Promotes Nerve Regeneration Following Experimental In-Continuity Nerve Injury. [2020]Brief electrical stimulation (ES) therapy to the nerve may improve outcome in lacerated, repaired nerves. However, most human nerve injuries leave the nerve in continuity with variable and often poor functional recovery from incomplete axon regeneration and reinnervation.
Effects of transcutaneous electrical nerve stimulation (TENS) on acute postoperative pain intensity and mobility after hip fracture: A double-blinded, randomized trial. [2022]Transcutaneous electrical nerve stimulation (TENS) is a noninvasive modality which may be used to reduce acute postoperative pain. Intense perioperative pain within the first few days after hip fracture surgery is common and is related to negative consequences such as restricted and delayed ambulation.
Electrical stimulation to enhance peripheral nerve regeneration: Update in molecular investigations and clinical translation. [2021]Peripheral nerve injuries are common and frequently result in incomplete functional recovery even with optimal surgical treatment. Permanent motor and sensory deficits are associated with significant patient morbidity and socioeconomic burden. Despite substantial research efforts to enhance peripheral nerve regeneration, few effective and clinically feasible treatment options have been found. One promising strategy is the use of low frequency electrical stimulation delivered perioperatively to an injured nerve at the time of surgical repair. Possibly through its effect of increasing intraneuronal cyclic AMP, perioperative electrical stimulation accelerates axon outgrowth, remyelination of regenerating axons, and reinnervation of end organs, even with delayed surgical intervention. Building on decades of experimental evidence in animal models, several recent, prospective, randomized clinical trials have affirmed electrical stimulation as a clinically translatable technique to enhance functional recovery in patients with peripheral nerve injuries requiring surgical treatment. This paper provides an updated review of the cellular physiology of electrical stimulation and its effects on axon regeneration, Level I evidence from recent prospective randomized clinical trials of electrical stimulation, and ongoing and future directions of research into electrical stimulation as a clinically feasible adjunct to surgical intervention in the treatment of patients with peripheral nerve injuries.
Long-term TENS treatment improves tactile sensitivity in MS patients. [2010]Transcutaneous electrical nerve stimulation (TENS) is commonly used in neurorehabilitation for the treatment of pain and spasticity.