Electrical Stimulation for Facial Palsy

Overseen By Peng Ding, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Bilateral facial paralysis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a short burst of electrical stimulation during surgery can improve nerve healing and enhance smile outcomes in people with facial palsy. It specifically targets individuals undergoing a two-stage procedure to restore their smile. The trial includes two groups: one receives electrical stimulation, known as Brief Electrical Stimulation (BES), during surgery, while the other does not. Ideal participants have facial paralysis on one side and are preparing for smile restoration surgery. As an unphased trial, this study offers participants the chance to contribute to pioneering research that could enhance future treatments for facial palsy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this electrical stimulation is safe for facial palsy treatment?

Research has shown that electrical stimulation can aid nerve healing, particularly after injuries. Some studies have found that applying electrical stimulation to facial muscles can enhance their movement and function.

For example, in animal studies, electrical stimulation helped nerves regenerate after damage, suggesting similar potential in humans. Another study demonstrated that electrical stimulation improved the function of facial muscles by enhancing their movement.

Electrical stimulation is generally safe, with few reports of serious side effects. However, like any treatment, it can cause minor issues such as mild discomfort or tingling at the application site. Overall, the evidence suggests that brief electrical stimulation during surgery could be safe for individuals with facial palsy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using brief electrical stimulation (BES) for facial palsy because it's a novel approach that could enhance nerve recovery during surgery. Unlike traditional treatments that focus on physical therapy and medication, BES directly stimulates the nerves for about 10 minutes during the first stage of cross-face nerve graft surgery. This direct stimulation has the potential to accelerate nerve regeneration and improve facial muscle function more effectively than current methods. By targeting the nerve itself, BES offers a promising new avenue to improve outcomes for people with facial palsy.

What evidence suggests that BES is effective for facial palsy?

Research shows that brief electrical stimulation (BES), which participants in this trial may receive, can aid nerve healing after injury. Studies have found that this method supports nerve regrowth, crucial for enhancing movement and function. In cases of facial paralysis, electrical stimulation can restore muscle control, resulting in improved smiles. Animal studies and some human trials support these findings. This trial will compare a treatment group receiving BES with a control group not receiving BES, focusing on the facial nerves and potentially accelerating recovery after surgery. Overall, BES appears promising for improving nerve repair and facial movement. ^{1 2 5 6 7}

Who Is on the Research Team?

Patrick Byrne, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-80 with one-sided facial paralysis who are suitable candidates for a specific two-stage nerve graft surgery aimed at restoring their smile. Participants must agree to join the study. Those with paralysis on both sides of the face or other medical conditions that prevent this surgery cannot take part.

Inclusion Criteria

Agree to participate in the study

Exclusion Criteria

I have paralysis on both sides of my face.

I have a health condition that prevents me from having a specific two-stage surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Treatment

Participants undergo nerve biopsies during surgery. The treatment group receives brief electrical stimulation therapy for approximately 10 minutes during the first stage cross-face nerve graft surgery.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for nerve regeneration and smile outcomes using nerve histology and clinical outcomes over a 24-month period.

24 months

What Are the Treatments Tested in This Trial?

Interventions

• BES

Trial Overview The study is testing whether a short session of electrical stimulation, called BES, during surgery can enhance nerve healing and improve smiling after undergoing cross-face nerve grafting procedures compared to standard surgical care without BES.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 1 Intervention

Treatment group undergoes nerve biopsies during surgery. In addition, patients in the treatment group receive brief electrical stimulation therapy for approximately 10 minutes during the first stage cross-face nerve graft surgery.

Group II: Control Group Experimental Treatment 1 Intervention

Control group undergoes only nerve biopsies during surgery - no brief electrical stimulation.

BES is already approved in United States for the following indications:

Approved in United States as BES for:

• Facial paralysis
• Nerve grafting

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Published Research Related to This Trial

In a study of 16 patients with Bell's palsy, electrical stimulation applied during the acute phase was found to be safe, but it did not show a statistically significant improvement in recovery compared to standard physiotherapy methods.

Both the experimental group receiving electrical stimulation and the control group showed improvement in facial function, but the differences in recovery rates were not significant, suggesting that electrical stimulation may not provide additional benefits over natural recovery and other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of electrical stimulation on House-Brackmann scores in early Bell's palsy. Alakram, P., Puckree, T.[2010]

In a study involving 18 rats, brief electrical stimulation (BES) applied immediately after facial nerve surgery significantly improved whisker movement at 2 weeks post-operation, with an average amplitude of 14.0° compared to 4.4° in the control group.

While BES showed initial benefits in accelerating recovery, by 4 and 6 weeks post-surgery, the differences in whisker movement between the BES group and the control group were not statistically significant, indicating that the long-term effects may not be as pronounced.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief electrical stimulation after facial nerve transection and neurorrhaphy: a randomized prospective animal study. Mendez, A., Seikaly, H., Biron, VL., et al.[2018]

The Micro-neurostimulator developed for intracranial electrical stimulation of the facial nerve allows for selective stimulation of tumor tissue and the facial nerve, which aids in precise tumor excision without damaging surrounding nerve tissue.

Key factors for the successful preservation of the facial nerve during surgery include the design of the stimulating electrode tips and the intensity of the electrical stimulus, which together ensure reliable nerve responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[How to preserve the facial nerve in acoustic neurinoma excision: development of a microneurostimulator]. Sekiya, T., Iwabuchi, T., Kiyomura, K.[2006]

A new method of electrically stimulating the facial nerve during surgery for medium and large acoustic tumors has been developed, which uses monopolar stimulation with low internal impedance.

This technique, combined with acoustic monitoring of facial muscle responses, helps to preserve facial nerve function and reduces the overall duration of the surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preservation of facial function during removal of acoustic neuromas. Use of monopolar constant-voltage stimulation and EMG. Møller, AR., Jannetta, PJ.[2004]

This study outlines a protocol for a rigorous clinical trial to assess the effectiveness of monophasic high volt electric stimulation (ES) in adults with acute Bell's palsy who have a poor prognosis for recovery, focusing on outcomes over a 6-month period.

The primary goal is to determine the proportion of patients achieving complete recovery, while also evaluating quality of life and potential side effects, which could provide valuable evidence on the therapeutic role of ES in Bell's palsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for randomized controlled trial of electric stimulation with high-volt twin peak versus placebo for facial functional recovery from acute Bell's palsy in patients with poor prognostic factors. Loyo, M., McReynold, M., Mace, JC., et al.[2023]

Intraoperative electrical stimulation can enhance the preservation of the facial nerve during acoustic neuroma surgery, but the intradural facial nerve requires specific stimulation protocols due to its unique anatomy and susceptibility to trauma.

The study found that insulating stimulating electrodes prevents current shunting caused by cerebrospinal fluid, and that monopolar and bipolar stimulation configurations have distinct electrical properties that can be tailored to clinical needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative facial nerve monitoring: a comparison of stimulating electrodes. Kartush, JM., Niparko, JK., Bledsoe, SC., et al.[2019]

In a study involving nine stroke patients with facial palsy, neuromuscular electrical stimulation applied for 30 minutes a day, 5 days a week, over 4 weeks significantly improved facial muscle strength and oral function.

The results suggest that electrical stimulation can be an effective intervention for enhancing facial muscle strength and addressing oral function issues in stroke patients experiencing dysphagia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of neuromuscular electrical stimulation on facial muscle strength and oral function in stroke patients with facial palsy. Choi, JB.[2020]

In a study of 38 adults with acute Bell's palsy, those receiving selective electrical muscle stimulation alongside usual physical therapy recovered facial function twice as fast (2.5 weeks) compared to those receiving only physical therapy (5.2 weeks).

The study found no significant differences in facial function or synkinesis between the two groups at any time point, suggesting that electrical stimulation is a safe and effective method to accelerate recovery without worsening symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of adding selective electrical muscle stimulation to usual physical therapy for Bell's palsy: immediate and six-month outcomes. Di Pietro, A., Cameron, M., Campana, V., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10299525/

Effects of Electrical Stimulation on Facial Paralysis ... Evidence is presented showing the efficacy of electrical stimulation in promoting nerve regeneration after peripheral nerve injuries in both animal models and ...

2. withpower.com withpower.com/trial/phase-bell-palsy-2-2023-a3af7?condition=bell%27s+palsy&hasNoPlacebo=false&overallStatus=Recruiting

Electrical Stimulation for Facial Palsy A research study to find out if brief intraoperative electrical stimulation therapy improves nerve regeneration and smile outcomes following two-stage cross ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06976814?locStr=Qatar&country=Qatar&rank=3

Study Details | NCT06976814 | Facial Palsy Treatment The Primary objective of the study is to investigate the most effective treatment modalities available to speech language pathologist as well as movement ...

4. liebertpub.com liebertpub.com/doi/10.1177/26893614251385556

Electric Stimulation Therapy for Bell's Palsy in the Acute ... Objective: To measure the effectiveness of electrical stimulation therapy as an add-on treatment for patients in the acute stage of Bell's palsy ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2352587825000919

Future innovations for the treatment of facial nerve paralysis Complete eyelid closure can be achieved through single-pulse, or the pulse-train electrical stimulation,, with the latter seemingly more effective and requiring ...

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06976814

Study Details | NCT06976814 | Facial Palsy Treatment Oral motor exercises to improve facial palsy. Participant Group/Arm, Experimental : Neuro Muscular Electrical Stimulation Arm + ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04457492

Functional Electrical Stimulation for Facial Muscles Functional electrical stimulation (FES) for facial paralysis is a technique in which muscles are electrically stimulated, causing them to contract This study is ...