Parkinson's DiseaseEarly Phase 1NCT03416452
Gait Disorders in Parkinson's Disease
A Early Phase 1 study testing vibratory cueing device and Mobile Gait Trainer in people with Parkinson's Disease, run by National Institute of Neurological Disorders and Stroke (NINDS).
Trial summary
Background: Parkinson s disease (PD) is a neurologic disorder that causes slowness, tremor, rigidity, and imbalance. Gait impairment is also common. There are 2 substudies: (1) Physiology of Freezing and Gait; (2) Vibratory Cueing. Healthy participants can join only Substudy 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- vibratory cueing device and Mobile Gait Trainer
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 24 Jan 2018to 13 Nov 2018
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Able to provide informed consent
- Clinical diagnosis of Parkinson disease by U.K. Parkinson Society Brain Bank Criteria
- Patients must be stage II -III on the Hoehn and Yahr scale
Who cannot join
- MoCA<25 within the last 6 months
- Uncontrolled medical condition requiring immediate treatment that would make a walking trial unsafe for the subject.
- Peripheral neuropathy that severely limits gait
- Current or recent orthopedic disorder that severely limits gait
- Current uncontrolled depression or major depressive episode
- Gait disorders other than PD.
Show all 11Show fewer
- Cannot walk safely without corrective lenses and without support.
- Unable to abstain from PD medications overnight for at least 12 hours before testing
- History of deep brain stimulation surgery
- Subjects who are NINDS employees
- In addition to the preceding criteria, healthy volunteers must also have a normal neurological examination performed within the last year. Healthy volunteers will be healthy subjects without any major medical and neurological or psychiatric disorders established by history and physical/neurological examination. They will also have no gait disorders from any medical or surgical problems as per clinical assessment.
About this study
Background:
Parkinson s disease (PD) is a neurologic disorder that causes slowness, tremor, rigidity, and imbalance. Gait impairment is also common. There are 2 substudies: (1) Physiology of Freezing and Gait; (2) Vibratory Cueing. Healthy participants can join only Substudy 1.
Read more
Objective:
To study gait disorders in PD. Also, to test the effect of specific interventions for gait in people with PD.
Eligibility:
People ages 18 and older who:
Have PD with bilateral symptoms but can walk without a cane or walker
Are healthy
Design:
Participants will be screened in Protocols 93-N-0202 and 01-N-0206.
Both substudies include a physical exam and medical history.
Substudy 1:
Participants will have one 6-hour visit. They must wear a tank tops and shorts with tennis shoes during the visit. They will perform gait tasks. Markers placed on the skin will record movements. They will have an EEG: They will wear an electrode cap to record brain waves. They will wear special glasses to record eye movements. Participants with PD will hold their morning dose of PD drugs. They can choose to be admitted to the hospital the previous evening. Otherwise someone else or a taxi must bring them to the visit. They will first perform the study tasks off their drugs. Then they will take their drugs and repeat them.
Substudy 2:
Participants will have one 3-hour visit. A small vibratory device will be attached to their ankle. Reflective markers placed on the skin will record movements while they walk:
Without the device
With the device, but the vibrator off
With the device, with the vibrator on
With a magnet attached to the ankle
Read the detailed description
The objective of this protocol is to study the physiology of gait disorders in Parkinson s disease as well as to test the effect of non-invasive interventions on gait function in patients with Parkinson s disease. To this end, this protocol will consist of two sub studies:
- Sub Study 1: Physiology of Freezing of Gait in Parkinson Disease (abbrev: Physiology of FOG)
- Objective: To explore temporospatial gait parameters and joint kinematic patterns in patients with Parkinson disease and freezing of gait. In addition, tracking of eye movements and EEG patterns will also be studied in patients with Parkinson disease and freezing of gait.
- Study Population: 15 PD patients with freezing of gait, 15 patients without freezing of gait, 15 age and gender matched healthy volunteers
- Design: Prospective Exploratory study
- Outcome Measures: Phase variability and coherence of oscillating axial and appendicular components of gait in patients with PD and freezing of gait, visual gaze fixations and saccades during freezing or freezing-like events and when approaching a variable width doorway, EEG patterns during an episode of freezing of gait or freeze-like event. The study will also aim to look at the difference in the phenomenon of FOG in OFF and ON states.
- Sub Study 2: Effects of Rhythmic Vibratory Cueing to Improve Step Parameters in Parkinson Disease (abbrev. Vibratory Cueing)
- Objective: To study changes in gait variables of patients with PD by providing rhythmic vibratory stimuli at the ankle on one limb at preset parameters.
- Study population: 15 patients diagnosed as having Parkinson s Disease, Hoehn and Yahr stage 2-3.
- Design: Prospective interventional hypothesis testing study. We will evaluate the effects of rhythmic vibratory cueing on gait variables in PD. The effects of vibratory cueing will be tested compared to baseline gait variables and with the use of a magnet (which will be the open label placebo intervention to account to some extent, for the open label design).
- Conditions
- Parkinson's Disease
- Being tested
- vibratory cueing device, Mobile Gait Trainer
- Keywords
- Gait, Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vibratory cueing deviceDevice
ankle brace with vibrator that provides electric stimulus
Mobile Gait TrainerDevice
standard rolling walker that has a battery operated sensor attached to the side, designed to detect footsteps
| Study group | Role | What they receive |
|---|---|---|
| PD patients no | Experimental | PD patients without freezing of gait Receives: Device: Mobile Gait Trainer |
| Healthy | Placebo comparator | HV using Mobile Gait Trainer Receives: Device: Mobile Gait Trainer |
| PD patients | Experimental | pd patients using vibratory cueing device Receives: Device: vibratory cueing device |
| PD patients 1 | Experimental | PD patients with freezing of gait Receives: Device: vibratory cueing device |
| Healthy Volunteers | Experimental | Age and gender matched healthy volunteers. Receives: Device: Mobile Gait Trainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine the relative phase variability or coherence between oscillating axial and appendicular components of gait in PD + FOG, compared to PD-FOG and healthy controls.
Measured: ongoing
Changes in Stride length
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start24 Jan 2018
- Primary completion13 Nov 2018
- Study completion13 Nov 2018
Why it stopped: Investigator left the NIH.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Supportive care
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Shabbir Hussain I Merchant, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03416452
- Sponsor's protocol ID
- 180050
- Other IDs
- 18-N-0050
- Status last verified
- Nov 2018
- First submitted
- 30 Jan 2018
- Last updated
- 20 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kelly VE, Eusterbrock AJ, Shumway-Cook A. The effects of instructions on dual-task walking and cognitive task performance in people with Parkinson's disease. Parkinsons Dis. 2012;2012:671261. doi: 10.1155/2012/671261. Epub 2012 Dec 29.
PubMed 23326758
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Disorders in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03416452
- Acronym / sponsor ID
- 180050
- Conditions
- Parkinson's Disease
- Keywords
- Gait, Parkinson's Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator left the NIH.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 24 Jan 2018 (actual)
- Primary completion
- 13 Nov 2018 (actual)
- Study completion
- 13 Nov 2018 (actual)
- First posted
- 31 Jan 2018 (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.
Background:
Parkinson s disease (PD) is a neurologic disorder that causes slowness, tremor, rigidity, and imbalance. Gait impairment is also common. There are 2 substudies: (1) Physiology of Freezing and Gait; (2) Vibratory Cueing. Healthy participants can join only Substudy 1.
Objective:
To study gait disorders in PD. Also, to test the effect of specific interventions for gait in people with PD.
Eligibility:
People ages 18 and older who:
Have PD with bilateral symptoms but can walk without a cane or walker
Are healthy
Design:
Participants will be screened in Protocols 93-N-0202 and 01-N-0206.
Both substudies include a physical exam and medical history.
Substudy 1:
Participants will have one 6-hour visit. They must wear a tank tops and shorts with tennis shoes during the visit. They will perform gait tasks. Markers placed on the skin will record movements. They will have an EEG: They will wear an electrode cap to record brain waves. They will wear special glasses to record eye movements. Participants with PD will hold their morning dose of PD drugs. They can choose to be admitted to the hospital the previous evening. Otherwise someone else or a taxi must bring them to the visit. They will first perform the study tasks off their drugs. Then they will take their drugs and repeat them.
Substudy 2:
Participants will have one 3-hour visit. A small vibratory device will be attached to their ankle. Reflective markers placed on the skin will record movements while they walk:
Without the device
With the device, but the vibrator off
With the device, with the vibrator on
With a magnet attached to the ankle
Detailed description
The objective of this protocol is to study the physiology of gait disorders in Parkinson s disease as well as to test the effect of non-invasive interventions on gait function in patients with Parkinson s disease. To this end, this protocol will consist of two sub studies:
- Sub Study 1: Physiology of Freezing of Gait in Parkinson Disease (abbrev: Physiology of FOG)
- Objective: To explore temporospatial gait parameters and joint kinematic patterns in patients with Parkinson disease and freezing of gait. In addition, tracking of eye movements and EEG patterns will also be studied in patients with Parkinson disease and freezing of gait.
- Study Population: 15 PD patients with freezing of gait, 15 patients without freezing of gait, 15 age and gender matched healthy volunteers
- Design: Prospective Exploratory study
- Outcome Measures: Phase variability and coherence of oscillating axial and appendicular components of gait in patients with PD and freezing of gait, visual gaze fixations and saccades during freezing or freezing-like events and when approaching a variable width doorway, EEG patterns during an episode of freezing of gait or freeze-like event. The study will also aim to look at the difference in the phenomenon of FOG in OFF and ON states.
- Sub Study 2: Effects of Rhythmic Vibratory Cueing to Improve Step Parameters in Parkinson Disease (abbrev. Vibratory Cueing)
- Objective: To study changes in gait variables of patients with PD by providing rhythmic vibratory stimuli at the ankle on one limb at preset parameters.
- Study population: 15 patients diagnosed as having Parkinson s Disease, Hoehn and Yahr stage 2-3.
- Design: Prospective interventional hypothesis testing study. We will evaluate the effects of rhythmic vibratory cueing on gait variables in PD. The effects of vibratory cueing will be tested compared to baseline gait variables and with the use of a magnet (which will be the open label placebo intervention to account to some extent, for the open label design).
Study design
- Primary purpose
- Supportive care
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| PD patients no | Experimental | Device: Mobile Gait TrainerPD patients without freezing of gait |
| Healthy | Placebo comparator | Device: Mobile Gait TrainerHV using Mobile Gait Trainer |
| PD patients | Experimental | Device: vibratory cueing devicepd patients using vibratory cueing device |
| PD patients 1 | Experimental | Device: vibratory cueing devicePD patients with freezing of gait |
| Healthy Volunteers | Experimental | Device: Mobile Gait TrainerAge and gender matched healthy volunteers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older
- Able to provide informed consent
- Clinical diagnosis of Parkinson disease by U.K. Parkinson Society Brain Bank Criteria
- Patients must be stage II -III on the Hoehn and Yahr scale
Key exclusion criteria (11 listed)
- MoCA<25 within the last 6 months
- Uncontrolled medical condition requiring immediate treatment that would make a walking trial unsafe for the subject.
- Peripheral neuropathy that severely limits gait
- Current or recent orthopedic disorder that severely limits gait
- Current uncontrolled depression or major depressive episode
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 |
|---|---|---|
| vibratory cueing deviceankle brace with vibrator that provides electric stimulus | Device | PD patients, PD patients 1 |
| Mobile Gait Trainerstandard rolling walker that has a battery operated sensor attached to the side, designed to detect footsteps | Device | Healthy, Healthy Volunteers, PD patients no |
Primary outcome
To examine the relative phase variability or coherence between oscillating axial and appendicular components of gait in PD + FOG, compared to PD-FOG and healthy controls.
Time frame: ongoing
Changes in Stride length
Time frame: ongoing
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- Background: PubMed 23326758Kelly VE, Eusterbrock AJ, Shumway-Cook A. The effects of instructions on dual-task walking and cognitive task performance in people with Parkinson's disease. Parkinsons Dis. 2012;2012:671261. doi: 10.1155/2012/671261. Epub 2012 Dec 29.
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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. This study is not recruiting at the moment.
Shabbir Hussain I Merchant, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing vibratory cueing device and Mobile Gait Trainer in people with Parkinson's Disease, run by National Institute of Neurological Disorders and Stroke (NINDS).
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 4 inclusion and 11 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: withdrawn, as of the sponsor's last update on 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To examine the relative phase variability or coherence between oscillating axial and appendicular components of gait in PD + FOG, compared to PD-FOG and healthy controls. (time frame: ongoing). The study lists 2 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 NCT03416452, which also lists 1 linked publication.
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 20 Nov 2018.