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Parkinson Disease (PD)XFNCT06602544

Robotic Apparel to Prevent Freezing of Gait in Parkinson Disease

A study testing Robotic Apparel in people with Parkinson Disease (PD), run by Harvard Medical School (HMS and HSDM) at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Freezing-of-gait (FoG) in Parkinson Disease (PD) is one of the most vivid and disturbing gait phenomena in neurology. Often described by patients as a feeling of "feet getting glued to the floor," FoG is formally defined as a "brief, episodic absence or marked reduction of forward progression of the feet despite the… Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Parkinson Disease (PD)
What is being tested?
Robotic Apparel
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesUnited States
Study dates
3 Sep 2024to Sep 2027
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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-90 years old
  • Self-reported Freezing of Gait due to PD
  • Score of 21 or higher on the cognitive screening test (Montreal Cognitive Assessment Score (MoCA))
  • Independent ambulation (with or without an assistive device, no physical assistance) for at least 20 meters
  • Able to understand, communicate, and be understood by study staff
  • Provide HIPAA Authorization to allow communication with the participant's treating physician/provider for medical clearance (if deemed necessary by study clinical team) to verify self-reported medical history (if deemed necessary by study clinical team)
  • Provide informed consent
  • Ability to participate in 8 research study visits

Who cannot join

  • More than 2 falls in the previous month, as a result of gait impairment (may enroll under clinician discretion)
  • Major surgery in the last 6 months that interferes with walking (may enroll under clinician discretion)
  • Gait deficits due to missing limbs
  • Experience chronic pain that interferes with walking ability (may enroll under clinician discretion)
  • Serious co-morbidities (unrelated to gait impairment) that may interfere with ability to participate in research (e.g. cardiovascular, neurological, skin, and vascular conditions such as acute, ongoing/unmanaged deep vein thrombosis)
  • No observable freezing-of-gait

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Franchino Porciuncula, EdD, PT, DScPT contact

617-353-7525

fporciun@bu.edu

Teresa Baker, DPT contact

617-353-7525

nwendel@bu.edu

United States2 sites, 2 recruiting

  • Harvard Science and Engineering Complex

    Allston, Massachusetts, 02134

    Conor J Walsh, PhD, 617-496-4269, walsh@seas.harvard.edu

    Christina Lee, PhD, 617-353-7525, christina_lee@g.harvard.edu

    Recruiting

  • Boston University Sargent College of Health and Rehabilitation Sciences

    Boston, Massachusetts, 02215

    Terry Ellis, PhD, PT, FAPTA, 617-353-7525, tellis@bu.edu

    Franchino Porciuncula, EdD, PT, DScPT, 617-353-7525, fporciun@bu.edu

    Recruiting

Other trials in United States

About this study

Official title: Preventing Freezing of Gait in Parkinson's Disease Using Soft Robotic Apparel

Freezing-of-gait (FoG) in Parkinson Disease (PD) is one of the most vivid and disturbing gait phenomena in neurology. Often described by patients as a feeling of "feet getting glued to the floor," FoG is formally defined as a "brief, episodic absence or marked reduction of forward progression of the feet despite the intention to walk." This debilitating gait phenomena is very common in PD, occurring in up to 80% of individuals with severe PD. When FoG arrests walking, serious consequences can occur such as loss of balance, falls, injurious events, consequent fear of falling, and increased hospitalization. Wearable robots are capable of augmenting spatiotemporal gait mechanics and are emerging as viable solutions for locomotor assistance in various neurological populations. For the proposed study, our goal is to understand how low force mechanical assistance from soft robotic apparel can best mitigate gait decline preceding a freezing episode and subsequent onset of FoG by improving spatial (e.g. stride length) and temporal features (e.g. stride time variability) of walking. We hypothesize that the ongoing gait-preserving effects can essentially minimize the accumulation of motor errors that lead to FoG. Importantly, the autonomous assistance provided by the wearable robot circumvents the need for cognitive or attentional resources, thereby minimizing risks for overloading the cognitive systems -- a known trigger for FoG, thus enhancing the repeatability and robustness of FoG-preventing effects.

Read the detailed description

Wearable robots are capable of augmenting spatiotemporal gait mechanics and are emerging as viable solutions for locomotor assistance in various neurological populations. Given the breakdown of spatiotemporal gait parameters prior to onset of FoG, we aim to understand how the use of mechanical assistance from a soft robotic apparel can best mitigate gait decline preceding a freezing episode, and subsequent onset of FoG through a multi-day proof-of-concept study. In Aim 1, we will determine the biomechanical mechanisms underpinning the effects of robotic apparel on FoG. We posit that robotic apparel will prevent FoG by supporting natural gait biomechanics and reducing motor errors and gait degradation (i.e., increase stride length, decrease stride variability) known to precede freezing. In Aim 2, we will quantify the impact of robotic apparel in preventing FoG in PD under a variety of walking conditions in a series of controlled laboratory-based experiments. We hypothesize that robotic apparel will be effective in preventing FoG as evidenced by lower percent time spent freezing and lower FoG severity ratio scores (IMU data, video annotation) during walking and turning, resulting in farther walking distances (2-Minute Walk Test) compared to unassisted walking, repeatable across days of testing. Additionally, we hypothesize that robotic apparel will be effective in preventing FoG across various walking contexts (i.e., walking in open spaces, turning, dual-tasking and medication on/off). In Aim 3, we will examine proof-of-concept of robotic apparel to prevent FoG in the home/community during walking, under FoG provoking conditions. We hypothesize that robotic apparel will be effective in preventing FoG, compared to unassisted walking, as evidenced by lower percent time spent freezing and lower FoG severity ratio scores (IMU data, video annotation) during walking in the home/community, including conditions that trigger FoG (e.g., personalized FoG "hotspots).

The study will utilize a soft robotic apparel that has previously shown to demonstrate robust, gait-preserving benefits and FoG prevention in a single-subject repeated measures case study. To examine the effectiveness of the intervention using our robotic apparel, this 9-visit study will collect data on amount of time spent freezing, spatiotemporal gait measures, clinical measures, and patient perspectives on the device during different standardized assessments and freeze-provoking activities across multiple environments (i.e. home, lab) and medication states (on, relative off) with and without the robotic apparel assistance.

Being tested
Robotic Apparel
Keywords
Parkinson Disease, Freezing-of-gait, Wearable Robot, Soft Robotics, Gait, Rehabilitation
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Robotic ApparelDevice

    A robotic apparel system is a portable, lightweight textile-based wearable robot that is worn around the waist and thighs. The apparel provides assistive flexion moment about the hip joint during the swing phase of gait by spooling in a cable that connects the thigh wraps to the front of the waist belt. Inertial measurement units embedded in the thigh wraps are used to control the timing of the robotic apparel assistance. Robotic apparel assistance magnitude is delivered as a small percentage of the bodyweight of the wearer.

Study groups in NCT06602544
Study groupRoleWhat they receive
Multi-visit ambulatory activities with soft robotic apparelExperimentalParticipants will engage in ambulatory activities (i.e. straight-line walking, turning) with and without the assistance of robotic apparel, performed across multiple visits under various freezing-of-gait (FoG) provoking scenarios
Receives: Device: Robotic Apparel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in percent time spent freezing

    Percent time spent freezing refers to cumulative duration spent freezing divided by the total duration of the task, expressed as percentage. Change in this outcome measure refers to the difference in percent time spent freezing during activities with and without assistance of robotic apparel.

    Measured: Visit 4 (within 6 months after enrollment)

  2. Change in percent time spent freezing

    Percent time spent freezing refers to cumulative duration spent freezing divided by the total duration of the task, expressed as percentage. Change in this outcome measure refers to the difference in percent time spent freezing during activities with and without assistance of robotic apparel.

    Measured: Visit 5 (within 6 months after enrollment)

  3. Change in percent time spent freezing

    Percent time spent freezing refers to cumulative duration spent freezing divided by the total duration of the task, expressed as percentage. Change in this outcome measure refers to the difference in percent time spent freezing during activities with and without assistance of robotic apparel.

    Measured: Visit 6 (within 6 months after enrollment)

  4. Change in percent time spent freezing

    Percent time spent freezing refers to cumulative duration spent freezing divided by the total duration of the task, expressed as percentage. Change in this outcome measure refers to the difference in percent time spent freezing during activities with and without assistance of robotic apparel.

    Measured: Visit 7 (within 6 months after enrollment)

  5. Change in percent time spent freezing

    Percent time spent freezing refers to cumulative duration spent freezing divided by the total duration of the task, expressed as percentage. Change in this outcome measure refers to the difference in percent time spent freezing during activities with and without assistance of robotic apparel.

    Measured: Visit 8 (within 6 months after enrollment)

  6. Change in percent time spent freezing

    Percent time spent freezing refers to cumulative duration spent freezing divided by the total duration of the task, expressed as percentage. Change in this outcome measure refers to the difference in percent time spent freezing during activities with and without assistance of robotic apparel.

    Measured: Visit 9 (within 6 months after enrollment)

  7. Change in stride length

    Stride length is the Euclidian distance between a point at heel strike at the beginning of gait cycle and a point at heel strike at the subsequent gait cycle. Change in this outcome measure refers to difference in stride length during activities with and without assistance of robotic apparel.

    Measured: Visit 4 (within 6 months after enrollment)

  8. Change in stride length

    Stride length is the Euclidian distance between a point at heel strike at the beginning of gait cycle and a point at heel strike at the subsequent gait cycle. Change in this outcome measure refers to difference in stride length during activities with and without assistance of robotic apparel.

    Measured: Visit 5 (within 6 months after enrollment)

  9. Change in stride length

    Stride length is the Euclidian distance between a point at heel strike at the beginning of gait cycle and a point at heel strike at the subsequent gait cycle. Change in this outcome measure refers to difference in stride length during activities with and without assistance of robotic apparel.

    Measured: Visit 6 (within 6 months after enrollment)

  10. Change in stride length

    Stride length is the Euclidian distance between a point at heel strike at the beginning of gait cycle and a point at heel strike at the subsequent gait cycle. Change in this outcome measure refers to difference in stride length during activities with and without assistance of robotic apparel.

    Measured: Visit 7 (within 6 months after enrollment)

  11. Change in stride length

    Stride length is the Euclidian distance between a point at heel strike at the beginning of gait cycle and a point at heel strike at the subsequent gait cycle. Change in this outcome measure refers to difference in stride length during activities with and without assistance of robotic apparel.

    Measured: Visit 8 (within 6 months after enrollment)

  12. Change in stride length

    Stride length is the Euclidian distance between a point at heel strike at the beginning of gait cycle and a point at heel strike at the subsequent gait cycle. Change in this outcome measure refers to difference in stride length during activities with and without assistance of robotic apparel.

    Measured: Visit 9 (within 6 months after enrollment)

Secondary outcomes (25)

  1. Change in freezing-of-gait ratio

    Freezing-of-gait ratio refers to the ratio between total power in the 3-8Hz band and the total power in the 0.5-3Hz band in the shank inertial measurement units. Change in this outcome measure refers to difference in freezing-of-gait ratio during activities with and without assistance of robotic apparel.

    Measured: Visit 4 (within 6 months after enrollment)

  2. Change in freezing-of-gait ratio

    Freezing-of-gait ratio refers to the ratio between total power in the 3-8Hz band and the total power in the 0.5-3Hz band in the shank inertial measurement units. Change in this outcome measure refers to difference in freezing-of-gait ratio during activities with and without assistance of robotic apparel.

    Measured: Visit 5 (within 6 months after enrollment)

  3. Change in freezing-of-gait ratio

    Freezing-of-gait ratio refers to the ratio between total power in the 3-8Hz band and the total power in the 0.5-3Hz band in the shank inertial measurement units. Change in this outcome measure refers to difference in freezing-of-gait ratio during activities with and without assistance of robotic apparel.

    Measured: Visit 6 (within 6 months after enrollment)

  4. Change in freezing-of-gait ratio

    Freezing-of-gait ratio refers to the ratio between total power in the 3-8Hz band and the total power in the 0.5-3Hz band in the shank inertial measurement units. Change in this outcome measure refers to difference in freezing-of-gait ratio during activities with and without assistance of robotic apparel.

    Measured: Visit 7 (within 6 months after enrollment)

  5. Change in freezing-of-gait ratio

    Freezing-of-gait ratio refers to the ratio between total power in the 3-8Hz band and the total power in the 0.5-3Hz band in the shank inertial measurement units. Change in this outcome measure refers to difference in freezing-of-gait ratio during activities with and without assistance of robotic apparel.

    Measured: Visit 8 (within 6 months after enrollment)

  6. Change in freezing-of-gait ratio

    Freezing-of-gait ratio refers to the ratio between total power in the 3-8Hz band and the total power in the 0.5-3Hz band in the shank inertial measurement units. Change in this outcome measure refers to difference in freezing-of-gait ratio during activities with and without assistance of robotic apparel.

    Measured: Visit 9 (within 6 months after enrollment)

  7. Change in 2-Minute Walk Test Distance

    2-Minute Walk Test distance refers to the farthest distance covered during 2 minutes of walking. Change in this outcome measure refers to difference in the 2-Minute Walk Test distance with and without assistance of robotic apparel.

    Measured: Visit 5 (within 6 months after enrollment)

  8. Change in 2-Minute Walk Test Distance

    2-Minute Walk Test distance refers to the farthest distance covered during 2 minutes of walking. Change in this outcome measure refers to difference in the 2-Minute Walk Test distance with and without assistance of robotic apparel.

    Measured: Visit 6 (within 6 months after enrollment)

  9. Change in 2-Minute Walk Test Distance

    2-Minute Walk Test distance refers to the farthest distance covered during 2 minutes of walking. Change in this outcome measure refers to difference in the 2-Minute Walk Test distance with and without assistance of robotic apparel.

    Measured: Visit 7 (within 6 months after enrollment)

  10. Change in 2-Minute Walk Test Distance

    2-Minute Walk Test distance refers to the farthest distance covered during 2 minutes of walking. Change in this outcome measure refers to difference in the 2-Minute Walk Test distance with and without assistance of robotic apparel.

    Measured: Visit 8 (within 6 months after enrollment)

  11. Change in 2-Minute Walk Test Distance

    2-Minute Walk Test distance refers to the farthest distance covered during 2 minutes of walking. Change in this outcome measure refers to difference in the 2-Minute Walk Test distance with and without assistance of robotic apparel.

    Measured: Visit 9 (within 6 months after enrollment)

  12. Change in range of motion

    Range of motion refers to the range (difference in maximum and minimum) of sagittal plane motion of the hip, knee, and ankle joints throughout a gait cycle. Change in this outcome measure refers to difference in the hip, ankle, and knee range-of-motion during activities with and without assistance of robotic apparel.

    Measured: Visit 4 (within 6 months after enrollment)

  13. Change in cadence

    Cadence refers to the number of steps or strides taken per minute. Change in this outcome measure refers to difference in the cadence during activities with and without assistance of robotic apparel.

    Measured: Visit 4 (within 6 months after enrollment)

  14. Change in cadence

    Cadence refers to the number of steps or strides taken per minute. Change in this outcome measure refers to difference in the cadence during activities with and without assistance of robotic apparel.

    Measured: Visit 5 (within 6 months after enrollment)

  15. Change in cadence

    Cadence refers to the number of steps or strides taken per minute. Change in this outcome measure refers to difference in the cadence during activities with and without assistance of robotic apparel.

    Measured: Visit 6 (within 6 months after enrollment)

  16. Change in cadence

    Cadence refers to the number of steps or strides taken per minute. Change in this outcome measure refers to difference in the cadence during activities with and without assistance of robotic apparel.

    Measured: Visit 7 (within 6 months after enrollment)

  17. Change in cadence

    Cadence refers to the number of steps or strides taken per minute. Change in this outcome measure refers to difference in the cadence during activities with and without assistance of robotic apparel.

    Measured: Visit 8 (within 6 months after enrollment)

  18. Change in cadence

    Cadence refers to the number of steps or strides taken per minute. Change in this outcome measure refers to difference in the cadence during activities with and without assistance of robotic apparel.

    Measured: Visit 9 (within 6 months after enrollment)

  19. Change in stride time variability

    Stride time variability refers to the difference in the coefficient of variance of stride time in each activity bout. Change in this outcome measure refers to difference in the stride time variability during activities with and without assistance of robotic apparel.

    Measured: Visit 4 (within 6 months after enrollment)

  20. Change in stride time variability

    Stride time variability refers to the difference in the coefficient of variance of stride time in each activity bout. Change in this outcome measure refers to difference in the stride time variability during activities with and without assistance of robotic apparel.

    Measured: Visit 5 (within 6 months after enrollment)

  21. Change in stride time variability

    Stride time variability refers to the difference in the coefficient of variance of stride time in each activity bout. Change in this outcome measure refers to difference in the stride time variability during activities with and without assistance of robotic apparel.

    Measured: Visit 6 (within 6 months after enrollment)

  22. Change in stride time variability

    Stride time variability refers to the difference in the coefficient of variance of stride time in each activity bout. Change in this outcome measure refers to difference in the stride time variability during activities with and without assistance of robotic apparel.

    Measured: Visit 7 (within 6 months after enrollment)

  23. Change in stride time variability

    Stride time variability refers to the difference in the coefficient of variance of stride time in each activity bout. Change in this outcome measure refers to difference in the stride time variability during activities with and without assistance of robotic apparel.

    Measured: Visit 8 (within 6 months after enrollment)

  24. Change in stride time variability

    Stride time variability refers to the difference in the coefficient of variance of stride time in each activity bout. Change in this outcome measure refers to difference in the stride time variability during activities with and without assistance of robotic apparel.

    Measured: Visit 9 (within 6 months after enrollment)

  25. Change in peak foot-to-floor angle

    Peak foot-to-floor angle refers to the maximum angle of the foot relative to ground as the foot dorsiflexes at heel strike, measured by the foot inertial measurement unit. Change in this outcome measure refers to difference in the stride time variability during activities with and without assistance of robotic apparel.

    Measured: Visit 4 (within 6 months after enrollment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start3 Sep 2024
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06602544
Sponsor's protocol ID
IRB#24-0986
Other IDs
024589
Acronym
XF
Status last verified
Jul 2025
First submitted
17 Sep 2024
Last updated
18 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Ziegler K, Schroeteler F, Ceballos-Baumann AO, Fietzek UM. A new rating instrument to assess festination and freezing gait in Parkinsonian patients. Mov Disord. 2010 Jun 15;25(8):1012-8. doi: 10.1002/mds.22993.

    PubMed 20310009

  • Ehgoetz Martens KA, Shine JM, Walton CC, Georgiades MJ, Gilat M, Hall JM, Muller AJ, Szeto JYY, Lewis SJG. Evidence for subtypes of freezing of gait in Parkinson's disease. Mov Disord. 2018 Jul;33(7):1174-1178. doi: 10.1002/mds.27417.

    PubMed 30153383

  • Plotnik M, Giladi N, Hausdorff JM. Is freezing of gait in Parkinson's disease a result of multiple gait impairments? Implications for treatment. Parkinsons Dis. 2012;2012:459321. doi: 10.1155/2012/459321. Epub 2012 Jan 12.

    PubMed 22288021

  • Nieuwboer A, Giladi N. Characterizing freezing of gait in Parkinson's disease: models of an episodic phenomenon. Mov Disord. 2013 Sep 15;28(11):1509-19. doi: 10.1002/mds.25683.

    PubMed 24132839

  • Alice N, Fabienne C, Anne-Marie W, Kaat D. Does freezing in Parkinson's disease change limb coordination? A kinematic analysis. J Neurol. 2007 Sep;254(9):1268-77. doi: 10.1007/s00415-006-0514-3. Epub 2007 Apr 2.

    PubMed 17401738

  • Nieuwboer A, Dom R, De Weerdt W, Desloovere K, Fieuws S, Broens-Kaucsik E. Abnormalities of the spatiotemporal characteristics of gait at the onset of freezing in Parkinson's disease. Mov Disord. 2001 Nov;16(6):1066-75. doi: 10.1002/mds.1206.

    PubMed 11748737

  • Hausdorff JM, Schaafsma JD, Balash Y, Bartels AL, Gurevich T, Giladi N. Impaired regulation of stride variability in Parkinson's disease subjects with freezing of gait. Exp Brain Res. 2003 Mar;149(2):187-94. doi: 10.1007/s00221-002-1354-8. Epub 2003 Jan 22.

    PubMed 12610686

  • Siviy C, Baker LM, Quinlivan BT, Porciuncula F, Swaminathan K, Awad LN, Walsh CJ. Opportunities and challenges in the development of exoskeletons for locomotor assistance. Nat Biomed Eng. 2023 Apr;7(4):456-472. doi: 10.1038/s41551-022-00984-1. Epub 2022 Dec 22.

    PubMed 36550303

  • Macht M, Kaussner Y, Moller JC, Stiasny-Kolster K, Eggert KM, Kruger HP, Ellgring H. Predictors of freezing in Parkinson's disease: a survey of 6,620 patients. Mov Disord. 2007 May 15;22(7):953-6. doi: 10.1002/mds.21458.

    PubMed 17377927

  • Nutt JG, Bloem BR, Giladi N, Hallett M, Horak FB, Nieuwboer A. Freezing of gait: moving forward on a mysterious clinical phenomenon. Lancet Neurol. 2011 Aug;10(8):734-44. doi: 10.1016/S1474-4422(11)70143-0.

    PubMed 21777828

  • Jacobs JV, Nutt JG, Carlson-Kuhta P, Stephens M, Horak FB. Knee trembling during freezing of gait represents multiple anticipatory postural adjustments. Exp Neurol. 2009 Feb;215(2):334-41. doi: 10.1016/j.expneurol.2008.10.019. Epub 2008 Nov 12.

    PubMed 19061889

  • Mancini M, Shah VV, Stuart S, Curtze C, Horak FB, Safarpour D, Nutt JG. Measuring freezing of gait during daily-life: an open-source, wearable sensors approach. J Neuroeng Rehabil. 2021 Jan 4;18(1):1. doi: 10.1186/s12984-020-00774-3.

    PubMed 33397401

Questions about this trial

What is this clinical trial studying?

A study testing Robotic Apparel in people with Parkinson Disease (PD), run by Harvard Medical School (HMS and HSDM) at 2 sites 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 8 inclusion and 6 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 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 Franchino Porciuncula, EdD, PT, DScPT (617-353-7525, fporciun@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in percent time spent freezing (time frame: Visit 4 (within 6 months after enrollment)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06602544, which also lists 12 linked publications.

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 18 Jul 2025.

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