Using Gaze to Enable Head-neck Movements in Patients With Head Drop

Overview

Official title

Using Gaze to Enable Personalized Head-neck Movements Through a Powered Neck Exoskeleton

Brief title

Using Gaze to Enable Head-neck Movements in Patients With Head Drop

Registration type

ClinicalTrials.gov

NCT number

NCT07836751

Status

Recruiting

Study category

Interventional, Device, Prevention

Sponsor / center

University of Utah

Research center

Not stated in the official study record.

Collaborators

Not stated in the official study record.

Study type

Interventional study

Phase

Not applicable / observational

Enrollment

12

Start date

06-30-2025

Primary completion date

10-31-2026

Estimated / actual completion date

12-01-2026

Last source update

09-23-2026

What is being studied?

The investigators will develop and evaluate controllers for a powered neck exoskeleton in patients with amyotrophic lateral sclerosis (ALS) to understand how to allow adequate personalization and function and achieves satisfaction from users. In this small device feasibility study, participants will be enrolled from the ALS clinic at the University of Utah Hospital. After obtaining written consent, participants will perform tasks while using the neck exoskeleton with the controllers. Tasks include computerized tracking tasks and simulated activities of daily living. Breaks will be added between tasks to avoid fatigue. Head-neck kinematics, gaze data, controller preferences, and survey responses will be recorded.

Intervention(s)

Who may be eligible?

This is a simplified summary. The official study team or research center determines eligibility.

Population / disease status

Diagnosed ALS

Diagnosis / conditions

Amyotrophic Lateral Sclerosis & Other Neuromuscular Disorders

Age

18 Years to Not stated in the official study record.

Disease duration

Not stated in the official study record.

Respiratory criteria

Not stated in the official study record.

ALSFRS-R criteria

Not stated in the official study record.

Genetic criteria

Not stated in the official study record.

Medication requirements

Not stated in the official study record.

Major inclusion and exclusion criteria from the official record

Inclusion Criteria:

* neck weakness and age over 18

Exclusion Criteria:

* Any cognitive deficits or visual impairments that would prevent from safely using the device and completing the tasks and poor device fitting.

Genetics

Gene-specific study?

No

Gene or variant

Any / Not gene-specific

Genetic test required?

Not stated in the official study record.

Known carrier required?

Not stated

Confirmed pathogenic variant required?

Not stated in the official study record.

Presymptomatic carriers eligible?

Not stated in the official study record.

At-risk relative eligible?

Not stated

Genetic test provided?

Not stated in the official study record.

Genetic counseling provided?

Not stated in the official study record.

Results returned / offered?

Not stated

Family history required?

Not stated in the official study record.

Study design

Randomized?

Not stated in the official study record.

Allocation

Not stated in the official study record.

Intervention model

Not stated in the official study record.

Masking

Not stated in the official study record.

Placebo

Not stated in the official study record.

Primary purpose

Not stated in the official study record.

Endpoints

Primary outcome measures

• number of tuning

Secondary outcome measures

Not stated in the official study record.

A biomarker outcome should not automatically be interpreted as a clinical outcome.

Locations

Contact

Central contact: Research Coordinator · uwrl@UofUtah.onmicrosoft.com · 801-585-2536