Parkinson's DiseaseNCT01935011
DBS Frequency on Swallowing Function in Parkinson's Disease
An observational study of Parkinson's Disease, run by University of Chicago at 1 site in United States.
Trial summary
The stimulation frequency has been found to affect the axial symptoms of freezing of gait (FOG) and speech in advanced Parkinson's disease (PD) patients with subthalamic nucleus deep brain stimulation (STN DBS), with the traditionally high stimulation frequency of 130 Hz worsening while low frequency of 60 Hz… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- PD, DBS
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Jul 2014
- Phase
- Observational
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eight PD patients with STN DBS and freezing of gait responsive to stimulation frequency changes will be enrolled.
Who may be able to join
- Eight PD patients with STN DBS and freezing of gait responsive to stimulation frequency changes will be enrolled.
Who cannot join
- Patients who do not meet the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of the Stimulation Frequency of STN DBS on Swallowing Function in Patients With Parkinson's Disease
The stimulation frequency has been found to affect the axial symptoms of freezing of gait (FOG) and speech in advanced Parkinson's disease (PD) patients with subthalamic nucleus deep brain stimulation (STN DBS), with the traditionally high stimulation frequency of 130 Hz worsening while low frequency of 60 Hz improving these symptoms. The effect of stimulation frequency on another important axial symptom, swallowing dysfunction, has not been studied. The investigators hypothesize that stimulation frequency could have similar effect on swallowing function.
Read the detailed description
This is the first study on the effect of the stimulation frequency on swallowing function in PD patients with STN DBS. Swallowing dysfunction is often difficult to treat pharmacologically and associated with increased morbidity and mortality. This study hence would have significant clinical implications in the management of swallowing dysfunction in these PD patients with STN DBS and could potentially decrease their morbidity and mortality.
The investigators expect that the traditionally high frequency stimulation of 130 Hz would worsen while the low frequency stimulation of 60 Hz would improve the swallowing function in OPMS summary
- Conditions
- Parkinson's Disease
- Being tested
- PD, DBS
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD, DBSOther
PD DBS frequency on swallowing function
| Study group | Role | What they receive |
|---|---|---|
| PD DBS 60 Hz, 130 Hz or DBS off | PD DBS on 60 Hz stimulation, 130 Hz stimulation or DBS off Receives: Other: PD, DBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome would be the OPMS swallowing function scores
Eight PD patients with STN DBS and FOG responsive to stimulation frequency changes will be enrolled. Information on the oropharyngeal motility study (OPMS) of the oral, pharyngeal and esophageal phase function will be collected, under "Med on/DBS off", "Med on/DBS 130 Hz", or "Med on/DBS 60 Hz". Each patient will be randomly assigned to these three conditions in a double blinded manner of 30 minutes apart. The patients will be reassessed under the single best condition (likely Med on/DBS 60 Hz) after being on for 6-8 weeks. ANOVA will be used for group comparison of the scores. A regression model will be further used to assess the predicting value (s) of the other scores and demographics for the swallowing function.
Measured: One year
Secondary outcomes (4)
The secondary outcome would be the swallowing questionnaire score
Eight PD patients with STN DBS and FOG responsive to stimulation frequency changes will be enrolled. Information on the swallowing questionnaire will be collected, under "Med on/DBS off", "Med on/DBS 130 Hz", or "Med on/DBS 60 Hz". Each patient will be randomly assigned to these three conditions in a double blinded manner of 30 minutes apart. The patients will be reassessed under the single best condition (likely Med on/DBS 60 Hz) after being on for 6-8 weeks.
Measured: One year
The secondary outcome would also be the unified PD rating scale
Eight PD patients with STN DBS and FOG responsive to stimulation frequency changes will be enrolled. Information on the unified PD rating scale will be collected, under "Med on/DBS off", "Med on/DBS 130 Hz", or "Med on/DBS 60 Hz". Each patient will be randomly assigned to these three conditions in a double blinded manner of 30 minutes apart. The patients will be reassessed under the single best condition (likely Med on/DBS 60 Hz) after being on for 6-8 weeks.
Measured: One year
The secondary outcome would be the FOG questionnaire score
Eight PD patients with STN DBS and FOG responsive to stimulation frequency changes will be enrolled. Information on the FOG questionnaire will be collected, under "Med on/DBS off", "Med on/DBS 130 Hz", or "Med on/DBS 60 Hz". Each patient will be randomly assigned to these three conditions in a double blinded manner of 30 minutes apart. The patients will be reassessed under the single best condition (likely Med on/DBS 60 Hz) after being on for 6-8 weeks.
Measured: One year
The secondary outcome would be the standing-walking-sitting test score
Eight PD patients with STN DBS and FOG responsive to stimulation frequency changes will be enrolled. Information on the standing-walking-sitting test will be collected, under "Med on/DBS off", "Med on/DBS 130 Hz", or "Med on/DBS 60 Hz". Each patient will be randomly assigned to these three conditions in a double blinded manner of 30 minutes apart. The patients will be reassessed under the single best condition (likely Med on/DBS 60 Hz) after being on for 6-8 weeks.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tao Xie, MD PhD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935011
- Sponsor's protocol ID
- 13-0566
- Status last verified
- Apr 2015
- First submitted
- 27 Aug 2013
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Stimulation Frequency of STN DBS on Swallowing Function in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01935011
- Acronym / sponsor ID
- 13-0566
- Conditions
- Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 4 Sep 2013 (estimated)
- 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 stimulation frequency has been found to affect the axial symptoms of freezing of gait (FOG) and speech in advanced Parkinson's disease (PD) patients with subthalamic nucleus deep brain stimulation (STN DBS), with the traditionally high stimulation frequency of 130 Hz worsening while low frequency of 60 Hz improving these symptoms. The effect of stimulation frequency on another important axial symptom, swallowing dysfunction, has not been studied. The investigators hypothesize that stimulation frequency could have similar effect on swallowing function.
Detailed description
This is the first study on the effect of the stimulation frequency on swallowing function in PD patients with STN DBS. Swallowing dysfunction is often difficult to treat pharmacologically and associated with increased morbidity and mortality. This study hence would have significant clinical implications in the management of swallowing dysfunction in these PD patients with STN DBS and could potentially decrease their morbidity and mortality.
The investigators expect that the traditionally high frequency stimulation of 130 Hz would worsen while the low frequency stimulation of 60 Hz would improve the swallowing function in OPMS summary
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD DBS 60 Hz, 130 Hz or DBS off | – | Other: PD, DBSPD DBS on 60 Hz stimulation, 130 Hz stimulation or DBS off |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eight PD patients with STN DBS and freezing of gait responsive to stimulation frequency changes will be enrolled.
Key inclusion criteria (1 listed)
- Eight PD patients with STN DBS and freezing of gait responsive to stimulation frequency changes will be enrolled.
Key exclusion criteria (1 listed)
- Patients who do not meet the inclusion criteria
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 |
|---|---|---|
| PD, DBSPD DBS frequency on swallowing function | Other | PD DBS 60 Hz, 130 Hz or DBS off |
Primary outcome
The primary outcome would be the OPMS swallowing function scores
Time frame: One year
Eight PD patients with STN DBS and FOG responsive to stimulation frequency changes will be enrolled. Information on the oropharyngeal motility study (OPMS) of the oral, pharyngeal and esophageal phase function will be collected, under "Med on/DBS off", "Med on/DBS 130 Hz", or "Med on/DBS 60 Hz". Each patient will be randomly assigned to these three conditions in a double blinded manner of 30 minutes apart. The patients will be reassessed under the single best condition (likely Med on/DBS 60 Hz) after being on for 6-8 weeks. ANOVA will be used for group comparison of the scores. A regression model will be further used to assess the predicting value (s) of the other scores and demographics for the swallowing function.
4 secondary outcomes
The secondary outcome would be the swallowing questionnaire score
Time frame: One year
The secondary outcome would also be the unified PD rating scale
Time frame: One year
The secondary outcome would be the FOG questionnaire score
Time frame: One year
The secondary outcome would be the standing-walking-sitting test score
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
Related trials for Parkinson's Disease
Not yet recruiting
Non-invasive Vagus Nerve Stimulation for Parkinson's Disease
Idiopathic Parkinson Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Bemdaneprocel in Adults Who Have Parkinson's Disease
Parkinsons Disease (PD)
RecruitingPhase 1
PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease
Parkinson's Disease, Dementia
Not yet recruiting
Cognitive-Motor Training for Gait Adaptability in Parkinson Disease
Parkinson Disease
Recruiting
Strength and Dual-Task on Sarcopenia in People With Parkinson's Disease
PARKINSON DISEASE (Disorder), Parkinsonism or Parkinson's Disease Nos
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.
Tao Xie, MD PhD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by University of Chicago 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: finished, as of the sponsor's last update on 28 Apr 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary outcome would be the OPMS swallowing function scores (time frame: One year). 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 28 Apr 2015.