Electrical Stimulation for Cubital Tunnel Syndrome

(PHONES Trial)

Not currently recruiting at 5 trial locations

Overseen By Kevin Scanlan, OTR

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Checkpoint Surgical Inc.

Disqualifiers: Arrythmia, 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: 11

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to enhance nerve healing after surgery for cubital tunnel syndrome, a condition where elbow nerve compression causes hand pain or weakness. Researchers aim to determine if a brief, 10-minute session of electrical stimulation (using the Checkpoint BEST System) during surgery can enhance recovery. Individuals with ulnar nerve issues at the elbow, such as muscle weakness or atrophy, who require surgery may be suitable candidates for this trial.

As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve surgical outcomes for future patients.

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 prior data suggests that this electrical stimulation technique is safe for nerve healing?

Research has shown that electrical stimulation can aid nerve healing after surgery. In previous studies, patients who received this treatment experienced better recovery without nerve harm. Notably, no side effects, such as nerve damage, were reported during or after the treatment. This suggests the treatment is safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard surgical approach for cubital tunnel syndrome, the Checkpoint BEST System introduces a brief electrical stimulation to the ulnar nerve during surgery. This unique method could enhance nerve recovery by stimulating the nerve in a way that promotes healing, potentially leading to faster or more effective symptom relief. Researchers are excited about this technique because it offers a novel way to support nerve repair, which could improve outcomes for patients undergoing decompression surgery.

What evidence suggests that electrical stimulation is effective for cubital tunnel syndrome?

Research has shown that electrical stimulation can aid nerve healing and improve function after surgery. In this trial, some participants will receive a single, 10-minute dose of electrical stimulation using the Checkpoint BEST System during surgical intervention for cubital tunnel decompression. Studies have found that brief electrical stimulation can accelerate nerve recovery by promoting axon regrowth, which are parts of nerve cells that send signals. Patients who underwent surgery for severe cubital tunnel syndrome (when a nerve in the elbow is compressed) experienced better recovery. This therapy is gaining popularity for its potential to enhance healing and outcomes in nerve-related surgeries. ^{1 2 3 6 7}

Who Is on the Research Team?

Amy M Moore, MD

Principal Investigator

The Ohio State Univeristy Department of Plastic and Reconstructive Surgery

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with ulnar nerve compression at the elbow who are scheduled for surgery. They must have signs of muscle weakness or wasting and confirmed ulnar neuropathy through tests. People with severe heart conditions, other nerve injuries in the arm, overall nerve disorders affecting hands, or very weak grip strength cannot join.

Inclusion Criteria

Signed and dated informed consent form

I am eligible for surgery.

Electrodiagnostic evidence of ulnar neuropathy at the elbow

Exclusion Criteria

I experience numbness or pain in my hands.

Previous history or current transection of ulnar nerve, or concomitant upper extremity nerve injury

My unaffected hand's grip strength is under 12kg.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Intervention

Surgical intervention for cubital tunnel decompression with a single, 10-minute dose of electrical stimulation delivered to the ulnar nerve

Single day

1 visit (in-person)

Follow-up

Participants are monitored for nerve healing and functional recovery through various assessments

1 year

Multiple visits at 10 days, 6 weeks, 3 months, 5 months, 7 months, 9 months, and 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Checkpoint BEST System

Trial Overview The study is testing a new use of electrical stimulation called Checkpoint BEST System to help heal nerves and improve hand function after surgery for ulnar nerve compression at the elbow. The treatment involves a single dose of stimulation during the surgical procedure.

How Is the Trial Designed?

Group I: Brief Electrical Stimulation Experimental Treatment 1 Intervention

Single, 10 minute dose of electrical stimulation delivered to the ulnar nerve during surgical intervention for cubital tunnel decompression.

Group II: Standard of Care Active Control 1 Intervention

Surgical intervention for cubital tunnel decompression.

Checkpoint BEST System is already approved in United States, European Union for the following indications:

Approved in United States as Checkpoint BEST System for:

• Pain management
• Neuropathic pain
• Chronic low back pain
• Diabetic neuropathy

Approved in European Union as Electrical Stimulation Therapy for:

• Pain management
• Neuropathic pain
• Muscle rehabilitation

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+

Published Research Related to This Trial

Cubital tunnel syndrome (CTS) is a common condition caused by ulnar nerve compression, leading to symptoms like numbness, tingling, and potential muscle weakness in the hand.

Treatment options for CTS include both nonsurgical methods and various surgical procedures, but the effectiveness and indications for each approach remain debated, highlighting the need for further research to establish a standardized treatment protocol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Progress of treatment of cubital tunnel syndrome]. Yu, S., Liu, S., Fan, C.[2018]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04662320

Promoting Healing of Nerves Through Electrical Stimulation Preliminary research has shown that delivering a brief period of electrical stimulation following nerve repair promotes nerve healing and functional recovery.

2. checkpointsurgical.com checkpointsurgical.com/research/clinical-trial-phones

Clinical Trial PHONES This study is investigating a new therapy that uses a single dose of electrical stimulation during surgery to promote healing and improve recovery of the ulnar ...

3. withpower.com withpower.com/trial/phase-ulnar-neuropathies-7-2021-9830f

Electrical Stimulation for Cubital Tunnel Syndrome · Info ... This study is evaluating a new therapeutic use of electrical stimulation to promote nerve healing and improve functional recovery following surgical ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8969122/

Short-Duration, Pulsatile, Electrical Stimulation Therapy ... Electrical stimulation (ES) applied at the time of nerve repair can accelerate axon regeneration, which may improve the likelihood of recovery.

5. journals.lww.com journals.lww.com/prsgo/fulltext/2024/04000/brief_intraoperative_electrical_stimulation_to.27.aspx

Brief Intraoperative Electrical Stimulation to Enhance Nerve ... Postsurgical electrical stimulation enhances recovery following surgery for severe cubital tunnel syndrome: a double-blind randomized controlled ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11005885/

Brief Intraoperative Electrical Stimulation to Enhance Nerve ... During surgery and follow-up, no adverse events related to treatment were reported (0%), including nerve injury or damage from the nerve ...

7. checkpointsurgical.com checkpointsurgical.com/research/bes

BES Electrical stimulation as a therapy for peripheral nerve healing has shown promising results in both animal and human trials in accelerating axon regrowth ...