Assessing Spinal Accessory Nerve Recovery After Post-operative Electrical Stimulation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorMcMaster University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Undergoing neck dissection

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

38 Participants
are divided into 2 treatment groups
Group A: Standard of CareNo intervention 0 interventions
Group B: Electrical stimulationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Constant Murley Score (CMS)

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.

Time frame
6 months post operative

Secondary outcomes

Other outcomes

Sponsors and contacts

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