Assessing Spinal Accessory Nerve Recovery After Post-operative Electrical Stimulation

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

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07074392

Acronym

SpARES

Enrollment

Registered

2025-07-20

Start date

2026-01-01

Completion date

2027-03-01

Last updated

2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer, Neck Dissection, Nerve Injury

Brief summary

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.

Interventions

DEVICEElectrical Stimulation

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Constant Murley Score (CMS)	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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026