Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07074392

Assessing Spinal Accessory Nerve Recovery After Post-operative Electrical Stimulation

Shoulder weakness and pain are common after neck dissection surgery for head and neck cancer. This is often caused by injury to the spinal accessory nerve, which controls important shoulder muscles. Recovery can be slow and incomplete, affecting patients' ability to return to daily activities. This project will test whether a brief, low-dose electrical stimulation treatment can help the nerve heal faster and improve shoulder function. The treatment is applied during surgery and is safe, non-invasive, and quick to deliver. If successful, this approach could lead to better rehabilitation, less disability, and improved quality of life for patients undergoing cancer surgery. The project also supports the development of new medical technology and offers a pathway to expand the use of electrical stimulation in other nerve injuries.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neck Dissection Neoplasms Neoplasms by Site Nerve Injury

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Undergoing neck dissection

Exclusion criteria

  • Previous neck dissection, previous implantable stimulator (i.e. pacemaker), previous spinal accessory nerve injury, pre-existing shoulder injury or weakness

Treatment and study plan

Electrical Stimulation

Device

Custom stimulator will deliver a 1hour stimulation protocol post-operatively at 20 Hz, with biphasic pulses (100 µs duration, 0-2mA amplitude range).

Primary outcomes

  1. Constant Murley Score (CMS)

    Time frame: 6 months post operative

    Shoulder function will be assessed using the Constant-Murley Score (CMS), a validated composite measure of shoulder function. The CMS ranges from 0 to 100 points, where higher scores indicate better shoulder function. The score incorporates four components: pain (15 points), activities of daily living (20 points), range of motion (40 points), and strength (25 points). A score of 100 represents full, pain-free shoulder function with normal strength and range of motion, while a score of 0 reflects complete dysfunction.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study title

Assessing the Feasibility and Effect of Post-operative Electrical Stimulation on Spinal Accessory Nerve Recovery After Neck Dissection for Head and Neck Cancer

Acronym: SpARES

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 20, 2025
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.