Nerve Transfer Surgery for Stroke Recovery

Recruiting in Palo Alto (17 mi)

Overseen by Jennifer Hong, Dr.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Pregnancy

No Placebo Group

Approved in 3 Jurisdictions

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.

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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.

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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.

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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

Trial 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

Participant Groups

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

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Dartmouth-Health Lebanon, NH

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center Lead Sponsor

References

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

Restoration of intrinsic hand function by superficial radial nerve: an anatomical study. [2023] The contralateral seventh cervical (cC7) nerve root transfer represents a cornerstone technique in treating total brachial plexus avulsion injury. Traditional cC7 procedures employ the entire ulnar nerve as a graft, which inevitably compromises its restorative capacity.

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

A novel mouse model of contralateral C7 transfer via the pretracheal route: A feasibility study. [2020] Contralateral seventh cervical nerve transfer (contralateral C7 transfer) is a novel treatment for patients with spastic paralysis, including stroke and traumatic brain injury. However, little is known on changes in plasticity that occur in the intact hemisphere after C7 transfer. An appropriate surgical model is required.

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] Contralateral cervical seventh (cC7) nerve to C7 transfer has been proven effective for treating spastic upper limb. However, for those whose major impairment is not in the C7 area, cC7 nerve transfer to other nerve(s) may achieve a better outcome. The aim of this study was to explore the optimal surgical approach for transferring cC7 to one or two nerves by cadaveric study and to discuss the possible applications for hemiplegic patients.

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] Contralateral C7 spinal nerve transfer is a useful operation for the treatment of brachial plexus root avulsion. The recovery of the independent function at the ipsilateral side, however, depends on neural circuitry reorganization in the central nervous system (CNS). This study tried to locate the CNS neuronal elements involved in the innervation of C7 spinal nerve.

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] Contralateral C7 (CC7) nerve transfer has successfully restored hand function in patients with spastic hemiplegia from chronic central nervous system injuries. However, little is known about the morphology and anatomy of the donor C7 nerve root in patients undergoing this procedure. This study quantified intraoperative measurements of donor C7 nerve roots during CC7 transfer surgery for spastic hemiplegia in patients treated at a high-volume center to describe observed anatomical variations for successful direct anastomosis.

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] To retrospectively determine the risks and benefits of contralateral C7 nerve root transfer in infants and children.

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

Microanatomy of the Separable Length of the C7. [2017] The objective of this study was to provide anatomical data on modified contralateral C7 (cC7) nerve root transfers by dissecting and measuring the separable lengths of the C7 root, trunk, and divisions.

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

Outcome of contralateral C7 transfers to different recipient nerves after global brachial plexus avulsion. [2021] Contralateral cervical seventh nerve root (CC7) transfer has been widely applied for treatment of traumatic brachial plexus injury. The purpose of the study was to evaluate outcomes of patients with global brachial plexus avulsion (GBPA) after CC7 transfer and compare the recoveries of median nerve as the only recipient nerve and one of the multiple recipient nerves.