Electrical Stimulation Therapy for Nerve Injury After Arm Surgery

(PHINEST Trial)

Recruiting at 1 trial location

Overseen By Eric Walker, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Checkpoint Surgical Inc.

Disqualifiers: Arrhythmia, Congestive heart failure, 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: 1

60 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{4 5 6 7 8}

How 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. ^{2 9 10 11 12}

Research Team

Amy M Moore, MD

Principal Investigator

Ohio State University

Eligibility 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.

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.

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)

Treatment Details

Interventions

• Checkpoint BEST System

Trial Overview 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.

Participant Groups

Group I: Brief Electrical Stimulation Therapy Experimental Treatment 1 Intervention

Single, 10 minute dose of electrical stimulation delivered to the injured nerve during surgical intervention.

Group II: Standard of Care Active Control 1 Intervention

Surgical intervention for repair of peripheral nerve injury.

Who Is Running the Clinical Trial?

Checkpoint Surgical Inc.

Lead Sponsor

Trials

3

Recruited

220+

Congressionally Directed Medical Research Programs

Collaborator

Trials

59

Recruited

10,600+

Findings from Research

In a randomized double-blind sham-controlled trial with 31 patients suffering from chronic pain, PENS therapy significantly reduced pain levels, with the median numerical rating scale (NRS) dropping from 7.5 to 0.5 after treatment (P < 0.0005).

PENS therapy also improved pain pressure thresholds (PPT), increasing from 202 gm to 626 gm, indicating enhanced pain tolerance compared to sham treatments, which showed minimal changes (P < 0.0001).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized double-blind sham-controlled crossover study of short-term effect of percutaneous electrical nerve stimulation in neuropathic pain. Raphael, JH., Raheem, TA., Southall, JL., et al.[2011]

Transcutaneous electrical nerve stimulation (TENS) shows promise in accelerating nerve regeneration and improving functional recovery based on a systematic review of six high-quality animal studies.

Low-frequency TENS was found to maintain normal myelination and increase axon quantity, while high-frequency TENS stimulated motor regeneration but resulted in fewer axons and signs of demyelination, indicating the need for careful consideration of TENS application parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Nerve Stimulation in Nerve Regeneration: A Systematic Review of In Vivo Animal Model Studies. Alarcón, JB., Chuhuaicura, PB., Sluka, KA., et al.[2022]

Lower skin impedance was found at optimal electrode sites for TENS treatment, suggesting that these sites may enhance the effectiveness of pain management techniques.

In a study with 24 healthy volunteers, both optimal and sham TENS treatments significantly increased pressure pain thresholds compared to a placebo, indicating that TENS is effective for pain relief, regardless of skin impedance at the electrode sites.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skin impedance is not a factor in transcutaneous electrical nerve stimulation effectiveness. Vance, CG., Rakel, BA., Dailey, DL., et al.[2022]

A review of nine randomized controlled trials involving 527 participants found that percutaneous electrical nerve stimulation (PENS) showed a statistically significant but clinically insignificant reduction in musculoskeletal pain compared to transcutaneous electrical nerve stimulation (TENS).

When focusing on studies with a lower risk of bias, there was no significant difference in pain reduction between PENS and TENS, indicating that both methods may be equally effective for managing pain intensity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous Versus Transcutaneous Electrical Nerve Stimulation for the Treatment of Musculoskeletal Pain. A Systematic Review and Meta-Analysis. Beltran-Alacreu, H., Serrano-Muñoz, D., Martín-Caro Álvarez, D., et al.[2022]

Patient-administered transcutaneous electrical nerve stimulation (TENS) after laparoscopic cholecystectomy was found to be safe and well-accepted by patients, with no reported adverse effects and high confidence in self-administration.

The study demonstrated strong blinding effectiveness using sub-sensory TENS as a sham control, suggesting that future research can reliably assess the analgesic efficacy of TENS in larger trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Administered Transcutaneous Electrical Nerve Stimulation for Postoperative Pain Control After Laparoscopic Cholecystectomy: A Randomized, Sham-Controlled Feasibility Trial. Xu, W., Varghese, C., Wells, CI., et al.[2022]

In a pilot study involving 20 patients with cancer pain, transcutaneous electrical nerve stimulation (TENS) was found to be safe, with 85% of patients using intensity-modulated TENS (IMT) reporting at least slight pain improvement compared to 50% with placebo TENS (PBT).

However, the overall change in average pain intensity did not significantly differ between IMT and PBT, suggesting that while TENS may be desired by patients, it may not provide greater analgesic effects than placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation for advanced cancer pain inpatients in specialist palliative care-a blinded, randomized, sham-controlled pilot cross-over trial. Siemens, W., Boehlke, C., Bennett, MI., et al.[2021]

A systematic review of 19 randomized controlled trials (RCTs) on transcutaneous electrical nerve stimulation (TENS) for chronic pain found that while active TENS showed positive analgesic outcomes in 10 out of 15 studies compared to inactive controls, the overall evidence is inconclusive due to poor methodological quality and variability in study designs.

The review highlighted a lack of clarity on the optimal stimulation parameters for TENS and emphasized the need for larger, well-designed multi-centre trials to better assess the long-term effectiveness of TENS in managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation (TENS) for chronic pain. Carroll, D., Moore, RA., McQuay, HJ., et al.[2018]

Transcutaneous electrical nerve stimulation (TENS) is a technique that uses electrical currents to stimulate peripheral nerves, effectively relieving various acute and chronic pain conditions, including those related to cancer.

Despite its widespread use, the evidence supporting TENS is often inconclusive due to methodological issues in randomized control trials, highlighting the need for more rigorous studies to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Nerve Stimulation (TENS) A Possible Aid for Pain Relief in Developing Countries? Tashani, O., Johnson, M.[2021]

In a study involving Lewis rats with neuroma-in-continuity injuries, brief electrical stimulation (ES) applied immediately after injury led to faster recovery and significantly improved locomotion function at 4 and 6 weeks compared to controls.

Although the benefits of brief ES diminished by 12 weeks, histomorphological analysis showed a greater percentage of neural tissue and a preference for motor nerve regeneration in the ES group, suggesting potential for this therapy in human nerve injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Electrical Stimulation Promotes Nerve Regeneration Following Experimental In-Continuity Nerve Injury. Shapira, Y., Sammons, V., Forden, J., et al.[2020]

In a study of 41 patients recovering from hip fracture surgery, the use of active TENS significantly reduced pain during walking compared to sham TENS, indicating its efficacy in managing acute postoperative pain.

Active TENS also improved walking distance and mobility on the fifth day post-surgery, suggesting it can enhance functional recovery when added to standard rehabilitation care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of transcutaneous electrical nerve stimulation (TENS) on acute postoperative pain intensity and mobility after hip fracture: A double-blinded, randomized trial. Elboim-Gabyzon, M., Andrawus Najjar, S., Shtarker, H.[2022]

Low frequency electrical stimulation applied during surgery for peripheral nerve injuries can significantly enhance recovery by promoting axon outgrowth and remyelination, potentially improving functional outcomes for patients.

Recent randomized clinical trials provide strong evidence supporting the use of electrical stimulation as a safe and effective adjunct to surgical repair, making it a promising option for improving recovery in patients with nerve injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical stimulation to enhance peripheral nerve regeneration: Update in molecular investigations and clinical translation. Zuo, KJ., Gordon, T., Chan, KM., et al.[2021]

In a study involving patients with multiple sclerosis, transcutaneous electrical nerve stimulation (TENS) applied for 3 weeks significantly improved hand sensitivity, achieving levels comparable to healthy individuals.

The increased tactile sensitivity was not only localized to the treated median nerve area but also extended to the ulnar nerve area, indicating a broader impact of TENS on sensory function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term TENS treatment improves tactile sensitivity in MS patients. Cuypers, K., Levin, O., Thijs, H., et al.[2010]

References

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

Randomized double-blind sham-controlled crossover study of short-term effect of percutaneous electrical nerve stimulation in neuropathic pain. [2011]

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

Transcutaneous Electrical Nerve Stimulation in Nerve Regeneration: A Systematic Review of In Vivo Animal Model Studies. [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Skin impedance is not a factor in transcutaneous electrical nerve stimulation effectiveness. [2022]

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

Percutaneous Versus Transcutaneous Electrical Nerve Stimulation for the Treatment of Musculoskeletal Pain. A Systematic Review and Meta-Analysis. [2022]

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

Patient-Administered Transcutaneous Electrical Nerve Stimulation for Postoperative Pain Control After Laparoscopic Cholecystectomy: A Randomized, Sham-Controlled Feasibility Trial. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation for advanced cancer pain inpatients in specialist palliative care-a blinded, randomized, sham-controlled pilot cross-over trial. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation (TENS) for chronic pain. [2018]

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

Transcutaneous Electrical Nerve Stimulation (TENS) A Possible Aid for Pain Relief in Developing Countries? [2021]

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

Brief Electrical Stimulation Promotes Nerve Regeneration Following Experimental In-Continuity Nerve Injury. [2020]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Effects of transcutaneous electrical nerve stimulation (TENS) on acute postoperative pain intensity and mobility after hip fracture: A double-blinded, randomized trial. [2022]

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

Electrical stimulation to enhance peripheral nerve regeneration: Update in molecular investigations and clinical translation. [2021]

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

Long-term TENS treatment improves tactile sensitivity in MS patients. [2010]