Nerve Transfer Surgery for Stroke Recovery

Overseen By Beverly Allen, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Pregnancy

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: Surgery and immediate recovery

95 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the limb functional improvement after contralateral C7 root transfer in stroke 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.

What data supports the effectiveness of the treatment Contralateral C7 root transfer for stroke recovery?

Research shows that contralateral C7 nerve transfer has successfully restored hand function in patients with spastic hemiplegia (paralysis on one side of the body) from chronic central nervous system injuries, suggesting its potential effectiveness for stroke recovery. ^{1 2 3 4 5}

Is contralateral C7 nerve transfer surgery safe for humans?

The contralateral C7 nerve transfer has been used in treating conditions like brachial plexus injuries in children, suggesting it is generally safe, but specific safety data for stroke recovery is not detailed in the available studies. ^{1 2 3 6 7}

How is the contralateral C7 nerve transfer treatment different from other treatments for stroke recovery?

Contralateral C7 nerve transfer is unique because it involves transferring a nerve from the healthy side of the body to the affected side, which can help restore function in patients with spastic paralysis from stroke. This surgical approach is different from other treatments as it directly targets nerve pathways to improve movement, rather than relying on medication or physical therapy alone. ^{1 2 3 5 8}

Research Team

Jennifer Hong, Dr.

Principal Investigator

Dartmouth-Hitchcock Medical Center

Eligibility Criteria

This trial is for stroke survivors with arm weakness or paralysis who haven't seen improvement after 1-5 years of rehab. It's not suitable for pregnant individuals.

Inclusion Criteria

I had a stroke that left my arm weak, and it hasn't gotten better in 1-5 years despite therapy.

Exclusion Criteria

Pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo contralateral C7 root transfer surgery for the treatment of spastic hemiparesis

Surgery and immediate recovery

1 visit (in-person)

Follow-up

Participants are monitored for changes in arm function using the Fugl-Meyer upper-extremity scale

12 months

Visits at baseline, 2, 4, 8, and 12 months post-surgery

Treatment Details

Interventions

• Contralateral C7 root transfer

Trial Overview The study tests a surgical procedure called contralateral C7 root transfer, aiming to improve arm function in patients with spastic hemiparesis due to stroke.

Participant Groups

Group I: Contralateral C7 root transfer for the treatment of spastic hemiparesis. Experimental Treatment 1 Intervention

The C7 nerve root transfer will occur to the patients on this arm.

Contralateral C7 root transfer is already approved in China, United States, European Union for the following indications:

Approved in China as CC7 nerve transfer for:

• Upper limb paralysis due to stroke
• Brachial plexus injury

Approved in United States as CC7 nerve transfer for:

• Upper limb paralysis due to stroke
• Traumatic brachial plexus injury

Approved in European Union as CC7 nerve transfer for:

• Upper limb paralysis due to stroke
• Brachial plexus avulsion injury

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

Findings from Research

The study successfully demonstrated a new technique using the superficial radial nerve (SRN) to connect the contralateral seventh cervical (cC7) nerve root to the motor branch of the ulnar nerve (MBUN) in a cadaveric model, preserving the MBUN's potential for recovery.

This innovative approach was technically viable in all ten cadaver limbs examined, suggesting that it could enhance future repair stages for patients with total brachial plexus avulsion injuries without compromising the ulnar nerve's restorative capacity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Restoration of intrinsic hand function by superficial radial nerve: an anatomical study. Liang, S., Liu, YZ., Hu, XQ., et al.[2023]

The study developed a novel mouse model for contralateral C7 nerve transfer, demonstrating that this method allows for direct tension-free neurorrhaphy in 66.7% of cases, which is more efficient than previous nerve grafting techniques.

Results showed significant nerve regeneration, including increased neurofilament expression and remyelination, along with functional recovery in behavioral and electrophysiological tests, indicating the model's potential for studying brain plasticity and new therapies for spastic paralysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel mouse model of contralateral C7 transfer via the pretracheal route: A feasibility study. Ye, X., Shen, YD., Feng, JT., et al.[2020]

The study found that using the deep surface of longus colli (dLC) approach for contralateral cervical seventh (cC7) nerve transfer significantly improved success rates compared to the superficial surface approach, particularly for transfers to C6 and C7 nerves.

Modified cC7 nerve transfer techniques are technically feasible and show promise for clinical application in patients with hemiplegia, with success rates reaching up to 98% for certain nerve transfers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cadaveric feasibility study of modified contralateral C7 nerve transfer for targeted functional recovery in hemiplegic upper extremity. Zhu, S., Ye, X., Feng, JT., et al.[2023]

The study successfully identified the central nervous system (CNS) neuronal elements that are involved in the innervation of the C7 spinal nerve using a pseudorabies virus (PRV) tracing technique in 20 adult rats.

PRV-labeled neurons were predominantly found in the gray matter of the spinal cord and specific brain structures, showing a shift from unilateral to bilateral distribution over time, which suggests neural circuitry reorganization is crucial for recovery after contralateral C7 spinal nerve transfer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of CNS neural circuitry involved in the innervation of C7 spinal nerve: a viral transsynaptic tracing study. Wei, HF., Chen, L., Gu, YD.[2018]

In a study of 21 patients undergoing contralateral C7 nerve transfer for spastic hemiplegia, the average length of the donor C7 nerve root was found to be 53.5 mm, with a diameter of 5.1 mm, providing important anatomical data for surgical procedures.

The research revealed that right-sided donor C7 nerve roots had significantly longer branches than left-sided ones, indicating anatomical variations that could impact the success of nerve transfer surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Anatomy of Human Donor C7 Nerve Roots for Surgical Transfer in Patients with Spastic Arm Paralysis. Ratican, S., Song, M., Qiu, Y., et al.[2021]

In a study of 12 infants and children with brachial plexus root avulsions, contralateral C7 nerve root transfer resulted in significant functional improvements, with 10 out of 12 patients gaining noteworthy motor function and all patients achieving sensory function after an average follow-up of 42 months.

The procedure caused minimal deficits in the donor limb, with only slight sensory damage and temporary shoulder abduction reduction in two infants, indicating that the benefits of improved motor and sensory function outweigh the risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contralateral C7 transfer for the treatment of brachial plexus root avulsions in children - a report of 12 cases. Chen, L., Gu, YD., Hu, SN., et al.[2022]

The study measured the lengths of the C7 nerve root and its divisions in 15 adult specimens, finding that the C7 root-trunk length averaged 45.87 mm, which is crucial for understanding nerve transfer techniques.

Dissecting the epineuria at the C7 division-cord junction significantly increased the lengths of the anterior and posterior divisions, suggesting that this technique can enhance the effectiveness of modified contralateral C7 nerve root transfers in patients with brachial plexus avulsion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microanatomy of the Separable Length of the C7. Qin, BG., Fu, G., Yang, JT., et al.[2017]

In a study of 51 patients with global brachial plexus avulsion, contralateral cervical seventh nerve (CC7) transfer significantly improved hand and wrist function, with effective recovery rates for the median nerve being 57.7% when CC7 was transferred solely to it.

The study found that using CC7 to repair multiple nerves did not hinder the recovery of the median nerve, and it suggested that the biceps branch is a better choice for a second recipient nerve compared to the triceps branch, as it resulted in greater improvement in elbow flexion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome of contralateral C7 transfers to different recipient nerves after global brachial plexus avulsion. Liu, Y., Yang, X., Gao, K., et al.[2021]

References

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

Restoration of intrinsic hand function by superficial radial nerve: an anatomical study. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

A novel mouse model of contralateral C7 transfer via the pretracheal route: A feasibility study. [2020]

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

Cadaveric feasibility study of modified contralateral C7 nerve transfer for targeted functional recovery in hemiplegic upper extremity. [2023]

4. China pubmed.ncbi.nlm.nih.gov

Identification of CNS neural circuitry involved in the innervation of C7 spinal nerve: a viral transsynaptic tracing study. [2018]

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

Clinical Anatomy of Human Donor C7 Nerve Roots for Surgical Transfer in Patients with Spastic Arm Paralysis. [2021]

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

Contralateral C7 transfer for the treatment of brachial plexus root avulsions in children - a report of 12 cases. [2022]

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

Microanatomy of the Separable Length of the C7. [2017]

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

Outcome of contralateral C7 transfers to different recipient nerves after global brachial plexus avulsion. [2021]