10 Participants Needed

Electrical Stimulation for Cervical Cord Injury

AV
TJ
Overseen ByThomas J Wilson, MD, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Stanford University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding electrical stimulation before and after nerve transfer surgery can enhance hand function and reduce pain for people with cervical spinal cord injuries. It involves a standard surgical procedure aimed at improving hand movement, with the addition of brief electrical stimulation to the nerves. Participants will receive care that is already part of standard medical practice, and no experimental treatments are involved. This trial suits individuals with a cervical spinal cord injury who currently have no hand function. As an unphased trial, this study offers participants the opportunity to contribute to innovative research that could improve future treatment options for cervical spinal cord injuries.

Do I have to stop taking my current medications for the trial?

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 protocol is safe for patients with cervical spinal cord injury?

Research has shown that electrical stimulation during and after nerve transfer surgery can be safe and effective. In one study, 73% of patients who received electrical stimulation during surgery fully recovered, while only 6% did not recover, suggesting the treatment is generally well-tolerated.

Another study found that long-term use of electrical stimulation at safe levels does not pose significant risks, allowing patients to use it over time without major safety concerns. Additionally, short-term electrical stimulation has helped with nerve healing after surgery, making it a promising addition to traditional methods.

Overall, evidence suggests that when used correctly, electrical stimulation is a safe option for improving outcomes in nerve transfer surgeries.12345

Why are researchers excited about this trial?

Researchers are excited about using nerve transfers combined with electrical stimulation to improve hand function in individuals with cervical spinal cord injuries because this approach offers a unique benefit over traditional methods. Unlike standard nerve transfer surgery, which only involves surgical rerouting of nerves, this innovative treatment adds intraoperative and postoperative electrical stimulation. This stimulation could enhance nerve regeneration and improve hand function recovery. By potentially accelerating and amplifying the healing process, this method could lead to more effective rehabilitation and better outcomes for patients with spinal cord injuries.

What evidence suggests that intraoperative and postoperative electrical stimulation could be effective for improving hand function and pain outcomes in cervical spinal cord injury?

Research has shown that using electrical stimulation during and after nerve transfer surgery can improve hand function in people with cervical spinal cord injuries. In this trial, participants in Arm B will receive standard nerve transfer surgery along with intraoperative and postoperative electrical stimulation. Studies have demonstrated that electrical stimulation helps nerves regenerate and reconnect with muscles more quickly. For instance, even brief electrical stimulation can enhance nerve recovery and muscle control. Animal studies have found that this method accelerates the healing process of nerves and their reconnection to muscles. Overall, evidence suggests that adding electrical stimulation to nerve transfer surgery could enhance hand function in patients.26789

Who Is on the Research Team?

TJ

Thomas J Wilson, MD, MPH

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

Inclusion Criteria

I am mentally and physically capable of following study procedures.
My nerve injury fits the specific time frame for surgery based on its type.
My health condition has been stable for at least 3 months.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Preoperative Assessment

Participants undergo a preoperative assessment including physical examination, electrodiagnostic studies, and functional electrical stimulation

1-2 weeks
1 visit (in-person)

Surgery and Intraoperative Stimulation

Participants undergo standard nerve transfer surgery with brief intraoperative electrical stimulation of the donor nerves

1 day
1 visit (in-person)

Postoperative Electrical Stimulation

Participants receive postoperative electrical stimulation via a temporary peripheral nerve stimulator for up to 60 days

8 weeks
Regular follow-up visits

Follow-up

Participants are monitored for motor and pain outcomes at 3, 6, 12, 24, and 36 months post-surgery

36 months
5 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Nerve Transfers Plus Electrical Stimulation

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Arm B: Standard nerve transfer surgery plus intraoperative and postoperative electrical stimulationExperimental Treatment2 Interventions
Group II: Arm A: Standard nerve transfer surgery without electrical stimulationExperimental Treatment0 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

United States Department of Defense

Collaborator

Trials
940
Recruited
339,000+

Citations

The Effect of Electrical Stimulation on Nerve Regeneration ...

Decades of animal studies have demonstrated that 20 Hz ES delivered post-surgically accelerates axonal outgrowth and end organ reinnervation.

Nerve Transfers Plus Electrical Stimulation to Improve ...

Peripheral nerve electrical stimulation has been shown to improve axonal regeneration, muscle reinnervation, and motor recovery and has been used to treat ...

The Role of Electrical Stimulation in Peripheral Nerve ...

Early studies of direct electrical stimulation of nerves demonstrated an overall positive effect, with greater axon sprouting, more rapid muscle reinnervation,

Conditioning Electrical Nerve Stimulation Enhances ...

We found that CES of donor nerves one week prior to nerve transfer surgery enhanced anatomical and functional measures of innervation of targeted muscles.

Electrical Stimulation to Enhance Peripheral Nerve ...

This was shown to improve nerve regeneration. These studies showed that as little as one hour of electrical stimulation was effective. Therefore ...

Intraoperative Electrical Nerve Stimulation as a Prognostic ...

Intraoperative stimulation at 0.5 mA was observed in 73% (33/45) of nerves, with 76% achieving full recovery, 18% partial recovery, and 6% no ...

Safety of long-term electrical peripheral nerve stimulation

Currently, chronic stimulation at frequencies below 30 Hz and percentages of effective stimulation time below 50% is considered safe.

Plastic and Reconstructive Surgery – Global Open

Perioperative application of 1-hour ES therapy is a feasible, safe, and promising approach to enhancing peripheral nerve regeneration as an adjunct to surgical ...

Application of electrical stimulation for peripheral nerve ...

Results showed that electrically stimulated patients had significantly recovered grip and pinch strengths within a year. When motor units were estimated at ...