Electrical Stimulation for Head and Neck Cancers

(SpARES Trial)

Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: McMaster 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 a new method to aid recovery from shoulder problems after head and neck cancer surgery. It focuses on using quick, low-dose electrical stimulation (a therapy involving electrical currents) during surgery to accelerate the healing of a key nerve, potentially improving shoulder movement and reducing pain. Candidates for the trial include those undergoing neck dissection surgery without a history of similar surgeries or existing shoulder issues. If successful, the treatment could ease daily life and enhance recovery for many patients. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that may improve recovery outcomes for future patients.

Do I need 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 is safe for head and neck cancer patients?

Research has shown that a brief electrical treatment during neck surgery might aid shoulder recovery. This treatment targets the spinal accessory nerve, often affected during surgery. Studies have found that this method can reduce shoulder issues post-surgery.

The electrical treatment is safe and quick. Patients who received it tolerated it well, with no serious side effects reported. This makes it a promising option for improving shoulder function after neck surgery for head and neck cancer.12345

Why are researchers excited about this trial?

Electrical stimulation for head and neck cancers is unique because it targets the spinal accessory nerve with electrical currents post-surgery, which is not typical for current treatments like surgery and radiation. This method aims to enhance nerve function and potentially improve recovery after neck dissection, an area where standard options often fall short. Researchers are excited about this approach because it could offer a non-invasive way to boost healing and nerve regeneration, potentially leading to better functional outcomes for patients.

What evidence suggests that electrical stimulation is effective for shoulder recovery after neck dissection surgery?

This trial will compare electrical stimulation with standard care for patients undergoing neck surgery. Studies have shown that electrical stimulation can improve shoulder movement after neck surgery. Research indicates that applying brief electrical stimulation to the nerve in the shoulder area during surgery may reduce shoulder pain and weakness. This quick, non-invasive method supports nerve healing. Initial findings suggest that patients receiving this treatment experience better shoulder movement and less pain. Overall, electrical stimulation might improve recovery and quality of life for those undergoing this type of cancer surgery.12356

Are You a Good Fit for This Trial?

This trial is for patients who have undergone neck dissection surgery due to head and neck cancers and are experiencing shoulder weakness or pain from spinal accessory nerve damage. The exact eligibility criteria are not provided, but typically participants must meet certain health standards.

Inclusion Criteria

I am scheduled for or have had a neck dissection.

Exclusion Criteria

Pre-existing shoulder injury or weakness
Previous implantable stimulator (i.e. pacemaker)
Previous spinal accessory nerve injury
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Post-operative electrical stimulation of the spinal accessory nerve during neck dissection surgery

During surgery

Follow-up

Participants are monitored for shoulder function recovery using the Constant-Murley Score

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Electrical Stimulation
Trial Overview The study is testing a low-dose electrical stimulation treatment applied during surgery to see if it can speed up healing of the spinal accessory nerve and improve shoulder function post-operation.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Electrical stimulationExperimental Treatment1 Intervention
Group II: Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials
936
Recruited
2,630,000+

Citations

Intraoperative Brief Electrical Stimulation of the Spinal ...Application of BES to the SAN may help reduce impaired shoulder function in patients undergoing oncologic neck dissection.
Brief Intraoperative Electrical Stimulation for Prevention of ...Brief intraoperative electrical stimulation of the spinal accessory nerve (ESSAN) continuously at 20 Hz, 10-15V for 60 minutes immediately following neck ...
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/29361981/
Intraoperative Brief Electrical Stimulation of the Spinal ...Application of BES to the SAN may help reduce impaired shoulder function in patients undergoing oncologic neck dissection.
Intraoperative brief electrical stimulation (BES) for prevention ...The aim of this study is to assess the efficacy of BES on postoperative clinical and objective shoulder functional outcomes and pain in HNC ...
Intraoperative Brief Electrical Stimulation of the Spinal ...Background Shoulder dysfunction is common after neck dissection for head and neck cancer (HNC). Brief electrical stimulation (BES) is a novel technique that ...
Intraoperative Brief Electrical Stimulation of the Spinal ...Shoulder dysfunction is common after neck dissection for head and neck cancer (HNC). Brief electrical stimulation (BES) is a novel technique that has been ...
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