Amyotrophic Lateral Sclerosis & Other Neuromuscular DisordersNCT07836751
Using Gaze to Enable Head-neck Movements in Patients With Head Drop
A study of Amyotrophic Lateral Sclerosis & Other Neuromuscular Disorders, run by University of Utah at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis & Other Neuromuscular Disorders
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- neck weakness and age over 18
Who cannot join
- Any cognitive deficits or visual impairments that would prevent from safely using the device and completing the tasks and poor device fitting.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Utah Wearable Robotics Laboratory, Dept. of Mechanical Engineering
Salt Lake City, Utah, 84112
Research Coordinator, 801-585-2536, uwrl@UofUtah.onmicrosoft.com
Haohan Zhang, PhD, 801-585-2536, haohan.zhang@utah.edu
About this study
Official title: Using Gaze to Enable Personalized Head-neck Movements Through a Powered Neck Exoskeleton
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.
- Being tested
- neck exoskeleton controller
- Keywords
- dropped head syndrome
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Dropped Head Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neck exoskeleton controllerDevice
Subjects will use the neck exoskeleton controller to move their head-neck and complete tasks involving head-neck motions. The neck exoskeleton will be worn and controlled by the users to assist them during tasks.
| Study group | Role | What they receive |
|---|---|---|
| controller 1 | Experimental | Not described Receives: Device: neck exoskeleton controller |
| controller 2 | Experimental | Not described Receives: Device: neck exoskeleton controller |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of tuning
number of user feedback provided to personalize/tune controller parameters for their preferred exoskeleton performance
Measured: during the intervention (using the exoskeleton to complete tasks) approximately 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start30 Jun 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral Sclerosis & Other Neuromuscular DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haohan Zhang, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836751
- Sponsor's protocol ID
- R21_Zhang_ALS_Gaze_Control
- Other IDs
- R21EB035378
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Gaze to Enable Personalized Head-neck Movements Through a Powered Neck Exoskeleton
- ClinicalTrials.gov ID
- NCT07836751
- Acronym / sponsor ID
- R21_Zhang_ALS_Gaze_Control
- Keywords
- dropped head syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| controller 1 | Experimental | Device: neck exoskeleton controller |
| controller 2 | Experimental | Device: neck exoskeleton controller |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- neck weakness and age over 18
Key exclusion criteria (1 listed)
- Any cognitive deficits or visual impairments that would prevent from safely using the device and completing the tasks and poor device fitting.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neck exoskeleton controllerSubjects will use the neck exoskeleton controller to move their head-neck and complete tasks involving head-neck motions. The neck exoskeleton will be worn and controlled by the users to assist them during tasks. | Device | controller 1, controller 2 |
Primary outcome
number of tuning
Time frame: during the intervention (using the exoskeleton to complete tasks) approximately 1 hour
number of user feedback provided to personalize/tune controller parameters for their preferred exoskeleton performance
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Amyotrophic Lateral Sclerosis & Other Neuromuscular Disorders, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Coordinator (801-585-2536, uwrl@UofUtah.onmicrosoft.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of tuning (time frame: during the intervention (using the exoskeleton to complete tasks) approximately 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.