Parkinson DiseaseNCT04147377
Effects of Behavioral Interventions Based on Sensory Cues on FOG in PD After STN-DBS
A study testing behavioral intervention based on sensory cues in people with Parkinson Disease, run by Seoul National University Hospital.
Trial summary
The investigators aims to assess the effectiveness of behavioral interventions based on sensory cues on freezing of gait in patients with Parkinson's disease after bilateral subthalamic nucleus deep brain stimulation. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- behavioral intervention based on sensory cues
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2020to 31 Dec 2020
- Phase
- Interventional
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Parkinson's disease who are aged 30 years or older
- Patients who underwent bilateral subthalamic nucleus deep brain stimulation
- Patients who complain of freezing of gait
Who cannot join
- Patients who have already used sensory cues for freezing of gait in clinical practice
- Patients with MMSE scores of 18 or lower
- Patients with Hoehn-Yahr scale 5
- Patients who have neurological symptoms associated with neurological disorders other than Parkinson's disease
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Behavioral Interventions Based on Sensory Cues on Freezing of Gait in Parkinson's Disease After Subthalamic Nucleus Stimulation
The investigators aims to assess the effectiveness of behavioral interventions based on sensory cues on freezing of gait in patients with Parkinson's disease after bilateral subthalamic nucleus deep brain stimulation.
Read the detailed description
Freezing of gait (FOG) leads to falling and is one of the major determinants of quality of life and prognosis in Parkinson's disease (PD). Previous evidence suggests that subthalamic nucleus deep brain stimulation (STN-DBS) improve off-medication FOG but not on-medication FOG in patients with PD. Furthermore, off-mediation FOG persist or even worsen after STN-DBS in some PD patients.
Although visual and auditory cues are known to improve FOG in research setting, it is unclear whether these cues are effective for FOG in real clinical setting. Most previous studies have used wearable devices to use sensory cues, but such devices are difficult to apply in clinical practice.
Therefore, this study aims to investigate the effectiveness of behavioral interventions based on visual and auditory cues in patients with PD after bilateral STN-DBS. Participants undergo clinical evaluations including the Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Frontal Assessment Battery (FAB), Unified Parkinson 's Disease Rating Scale (UPDRS), Freezing of Gait-Questionnaire (FOG-Q), and the average number of falling over the last week. Then, participants receive behavior intervention training that includes how to apply visual and auditory cues to freezing of gait in real clinical practice. To investigate the education effect, FOG-Q and the average number of falling over the last week are repetitively assessed at 2-week and 4-week follow-ups using a phone call.
- Conditions
- Parkinson Disease
- Being tested
- behavioral intervention based on sensory cues
- Keywords
- Parkinson's disease, Freezing of gait, visual cue, auditory cue, subthalamic nucleus, deep brain stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral intervention based on sensory cuesBehavioural
Patients will receive behavior intervention training that includes how to apply visual and auditory cues to freezing of gait in real clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| PD with FOG | Experimental | Patients with Parkinson's disease who complain of freezing of gait Receives: Behavioral: behavioral intervention based on sensory cues |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to 4-week f/u in FOG-Q subscore (Q4+Q5+Q6)
The FOG-Q will be used to determine the efficacy of behavior intervention based on sensory cues.
Measured: baseline, after 4 weeks
Change from baseline to 4-week f/u in the number of falling
We will ask about the average number of falling over the last week at baseline and at 4-week f/u.
Measured: baseline, after 4 weeks
Secondary outcomes (4)
Change from baseline to 4-week f/u in FOG-Q total score
The FOG-Q will be used to determine the efficacy of behavior intervention based on sensory cues.
Measured: baseline, after 4 weeks
Change from baseline to 2-week f/u in FOG-Q
The FOG-Q will be used to determine the efficacy of behavior intervention based on sensory cues.
Measured: baseline, after 2 weeks
Change from baseline to 2-week f/u in the number of falling
We will ask about the average number of falling over the last week at baseline and at 2-week f/u.
Measured: baseline, after 2 weeks
Change from baseline to 2-week f/u in FOG-Q subscore (Q4+Q5+Q6)
The FOG-Q will be used to determine the efficacy of behavior intervention based on sensory cues.
Measured: baseline, after 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start1 Jan 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BS Jeon, Seoul National University Hospital
- Investigators
- Beomseok Jeon, Professor, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04147377
- Sponsor's protocol ID
- H-1910-104-1071
- Status last verified
- Dec 2019
- First submitted
- 30 Oct 2019
- Last updated
- 18 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Behavioral Interventions Based on Sensory Cues on Freezing of Gait in Parkinson's Disease After Subthalamic Nucleus Stimulation
- ClinicalTrials.gov ID
- NCT04147377
- Acronym / sponsor ID
- H-1910-104-1071
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's disease, Freezing of gait, visual cue, auditory cue, subthalamic nucleus, deep brain stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 1 Nov 2019 (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 aims to assess the effectiveness of behavioral interventions based on sensory cues on freezing of gait in patients with Parkinson's disease after bilateral subthalamic nucleus deep brain stimulation.
Detailed description
Freezing of gait (FOG) leads to falling and is one of the major determinants of quality of life and prognosis in Parkinson's disease (PD). Previous evidence suggests that subthalamic nucleus deep brain stimulation (STN-DBS) improve off-medication FOG but not on-medication FOG in patients with PD. Furthermore, off-mediation FOG persist or even worsen after STN-DBS in some PD patients.
Although visual and auditory cues are known to improve FOG in research setting, it is unclear whether these cues are effective for FOG in real clinical setting. Most previous studies have used wearable devices to use sensory cues, but such devices are difficult to apply in clinical practice.
Therefore, this study aims to investigate the effectiveness of behavioral interventions based on visual and auditory cues in patients with PD after bilateral STN-DBS. Participants undergo clinical evaluations including the Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Frontal Assessment Battery (FAB), Unified Parkinson 's Disease Rating Scale (UPDRS), Freezing of Gait-Questionnaire (FOG-Q), and the average number of falling over the last week. Then, participants receive behavior intervention training that includes how to apply visual and auditory cues to freezing of gait in real clinical practice. To investigate the education effect, FOG-Q and the average number of falling over the last week are repetitively assessed at 2-week and 4-week follow-ups using a phone call.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD with FOG | Experimental | Behavioral: behavioral intervention based on sensory cuesPatients with Parkinson's disease who complain of freezing of gait |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with Parkinson's disease who are aged 30 years or older
- Patients who underwent bilateral subthalamic nucleus deep brain stimulation
- Patients who complain of freezing of gait
Key exclusion criteria (4 listed)
- Patients who have already used sensory cues for freezing of gait in clinical practice
- Patients with MMSE scores of 18 or lower
- Patients with Hoehn-Yahr scale 5
- Patients who have neurological symptoms associated with neurological disorders other than Parkinson's disease
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 |
|---|---|---|
| behavioral intervention based on sensory cuesPatients will receive behavior intervention training that includes how to apply visual and auditory cues to freezing of gait in real clinical practice. | Behavioural | PD with FOG |
Primary outcome
Change from baseline to 4-week f/u in FOG-Q subscore (Q4+Q5+Q6)
Time frame: baseline, after 4 weeks
The FOG-Q will be used to determine the efficacy of behavior intervention based on sensory cues.
Change from baseline to 4-week f/u in the number of falling
Time frame: baseline, after 4 weeks
We will ask about the average number of falling over the last week at baseline and at 4-week f/u.
4 secondary outcomes
Change from baseline to 4-week f/u in FOG-Q total score
Time frame: baseline, after 4 weeks
Change from baseline to 2-week f/u in FOG-Q
Time frame: baseline, after 2 weeks
Change from baseline to 2-week f/u in the number of falling
Time frame: baseline, after 2 weeks
Change from baseline to 2-week f/u in FOG-Q subscore (Q4+Q5+Q6)
Time frame: baseline, after 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2019.
- Individual participant dataSharing planned: No
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
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.
Beomseok Jeon, Professor principal investigator
Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing behavioral intervention based on sensory cues in people with Parkinson Disease, run by Seoul National University Hospital.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 18 Dec 2019. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beomseok Jeon, Professor (+82-2-2072-2876, brain@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to 4-week f/u in FOG-Q subscore (Q4+Q5+Q6) (time frame: baseline, after 4 weeks). 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?
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 Dec 2019.