Nerve Transfer Techniques for Facial Palsy

Overseen By Z-Hye Lee, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy

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

Compensation: Varies

Number of Visits: 4

40 Participants Needed

Trial Summary

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 study team or your doctor.

What data supports the effectiveness of the treatment Nerve Transfer Techniques for Facial Palsy?

Research shows that nerve transfer techniques, like masseter-to-facial nerve transfer, are effective and safe for treating facial palsy, improving smile movement in patients. Additionally, cross-face nerve grafting has shown good results in reanimating paralyzed facial muscles, with most patients experiencing satisfactory recovery. ^{1 2 3 4 5}

Is nerve transfer for facial palsy safe?

Nerve transfer techniques for facial palsy, such as masseteric and hypoglossal nerve transfers, have been shown to be generally safe in humans, with adverse effects being rare (less than 5%). ^{4 5 6 7 8}

How does the nerve transfer treatment for facial palsy differ from other treatments?

Nerve transfer techniques for facial palsy, such as masseter-to-facial nerve transfer and cross-face nerve grafting, are unique because they involve rerouting nerves from other parts of the body to restore movement in paralyzed facial muscles. This approach is different from other treatments as it directly addresses nerve damage by creating new nerve pathways, offering a more physiological and potentially effective solution for facial reanimation. ^{2 3 4 5 9}

What is the purpose of this trial?

The goal of this research study is to measure changes in patients' quality of life after surgeries that affect the facial nerve, including nerve transfer as treatment for facial paralysis.

Research Team

Z-Hye Lee, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for individuals with facial paralysis due to Bell's Palsy or cancer in the head and neck area. Participants should be those who have not seen improvement with standard treatments and are seeking surgical options to improve their facial function.

Inclusion Criteria

For intervention group: Provision of signed and dated informed consent form

I am scheduled for a facial nerve transfer surgery.

For non-intervention historical control group: Provision of signed and dated informed consent form

Exclusion Criteria

Patients known to be pregnant

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo facial nerve transfer techniques to improve facial function and quality of life

1 day

1 visit (in-person)

Post-operative Follow-up

Participants are monitored for changes in quality of life and facial function using validated questionnaires at 6, 12, and 18 months post-operatively

18 months

3 visits (in-person)

Safety Monitoring

Monitoring for safety and adverse events throughout the study duration

1 year

Treatment Details

Interventions

• Nerve Transfer Techniques

Trial Overview The study focuses on nerve transfer techniques as a surgical intervention to treat facial paralysis. It aims to assess how these surgeries can enhance patients' quality of life by restoring some degree of facial movement.

Participant Groups

Group I: Surgery Experimental Treatment 1 Intervention

Group II: Control Experimental Treatment 1 Intervention

Participants will be identified and recruited during their visit to the Center of Reconstructive Surgery.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Findings from Research

Nerve transfer (NT) and free gracilis muscle transfer (FGMT) significantly improved smile excursion and facial symmetry in patients with facial paralysis, with NT showing a notable increase in oral commissure excursion from 0.4 mm to 2.9 mm (P=0.05).

Quality of life, as measured by the Facial Clinimetric Evaluation (FaCE) Scale, improved significantly in patients who underwent NT (P<0.001), indicating that these surgical interventions not only enhance physical outcomes but also positively impact patients' overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Outcomes in an Emerging Facial Nerve Center: The Oregon Health and Science University (OHSU) Experience. Krane, NA., Chen, JS., Hanseler, H., et al.[2022]

Masseteric nerve transfers are effective in restoring significant movement in patients with facial paralysis, although the quality of tone may be poor.

The hypoglossal to facial nerve transfer is a reliable method that improves facial tone and has been enhanced with a transposition technique, resulting in good outcomes with minimal complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facial reanimation: an update on nerve transfers in facial paralysis. Jandali, D., Revenaugh, PC.[2020]

Cross-face nerve grafting has shown promising results in reanimating the paralyzed side of the face in patients with facial paralysis, with 8 out of 10 cases achieving good or satisfactory outcomes after surgery.

The overall success of this technique suggests it should be the first approach in treating facial palsy, while other methods should be considered only if further improvement is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cross-face nerve grafting in facial paralysis. Monballiu, G.[2004]

In a study of seven patients with facial paralysis after skull base surgery, masseteric nerve transfer combined with cross-facial nerve grafting successfully reanimated the midface in all but one patient, with facial motion developing on average 4 months post-surgery.

The procedure resulted in negligible donor site morbidity, as none of the patients experienced impaired chewing function or visible wasting of the masseter muscle, indicating it is a safe and effective option for facial reanimation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Masseteric nerve transfer for short-term facial paralysis following skull base surgery. Yoshioka, N., Tominaga, S.[2015]

In a study of 7 patients with complete facial nerve paralysis, those who received masseter-to-facial nerve transfers within 6 months of denervation showed significantly better outcomes in mouth movement (11.1 mm vs. 6.5 mm) compared to those who had the procedure after 6 months.

Transferring the masseter nerve to the main facial nerve trunk resulted in a greater improvement in facial symmetry (31.6% improvement) compared to selective transfers, suggesting that the timing and technique of nerve transfer are crucial for optimal recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Masseter to Facial Nerve Transfer May Improve Smile Excursion in Facial Paralysis. Zhang, S., Hembd, A., Ching, CW., et al.[2022]

Hypoglossal nerve transfer resulted in better oral commissure symmetry at rest compared to masseteric transfer, indicating a potential advantage in facial appearance after surgery.

Masseteric nerve transfer led to faster reinnervation and better overall facial function as measured by the Sunnybrook Facial Nerve Grading Scale, suggesting it may be more effective for quicker recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypoglossal and Masseteric Nerve Transfer for Facial Reanimation: A Systematic Review and Meta-Analysis. Urban, MJ., Eggerstedt, M., Varelas, E., et al.[2022]

Facial reanimation surgery significantly improves facial function in patients with iatrogenic facial palsy, as evidenced by reduced lagophthalmos and improved mouth function after the procedure.

The study analyzed 128 patients, revealing that the duration of facial palsy (averaging 7.8 years) negatively correlates with postoperative smiling function, highlighting the importance of early referral to a facial nerve center for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional results after facial reanimation in iatrogenic facial palsy. Györi, E., Mayrhofer, M., Schwaiger, BM., et al.[2021]

In a study of 46 patients with complete unilateral facial paralysis, both hemihypoglossal transposition with a nerve graft and direct masseteric-facial coaptation effectively reanimated facial movement, but the masseteric technique showed better symmetry and faster onset of movement (62 days vs. 136 days).

The masseteric-facial coaptation technique also avoids the additional surgical risks associated with harvesting a nerve graft, making it a safer option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of hemihypoglossal nerve versus masseteric nerve transpositions in the rehabilitation of short-term facial paralysis using the Facial Clima evaluating system. Hontanilla, B., Marré, D.[2022]

Cross face nerve transplantation is a two-stage surgical technique for treating facial palsy, showing superior outcomes compared to other substitution methods, especially in cases of nerve regeneration.

In a review of 35 patients, while this technique does not achieve the same quality of recovery as direct repair of the ipsilateral facial nerve, it is recommended for patients under 50 years old, as older patients may benefit more from simpler procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cross-face nerve transplantation in facial palsy. Anderl, H.[2004]

References

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

Early Outcomes in an Emerging Facial Nerve Center: The Oregon Health and Science University (OHSU) Experience. [2022]

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

Facial reanimation: an update on nerve transfers in facial paralysis. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Cross-face nerve grafting in facial paralysis. [2004]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Masseteric nerve transfer for short-term facial paralysis following skull base surgery. [2015]

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

Early Masseter to Facial Nerve Transfer May Improve Smile Excursion in Facial Paralysis. [2022]

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

Hypoglossal and Masseteric Nerve Transfer for Facial Reanimation: A Systematic Review and Meta-Analysis. [2022]

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

Functional results after facial reanimation in iatrogenic facial palsy. [2021]

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

Comparison of hemihypoglossal nerve versus masseteric nerve transpositions in the rehabilitation of short-term facial paralysis using the Facial Clima evaluating system. [2022]

9. Finland pubmed.ncbi.nlm.nih.gov

Cross-face nerve transplantation in facial palsy. [2004]