Idiopathic Parkinson's DiseaseNCT00869830
The Effectiveness of Biofeedback Treatment in Constipated Patients With Idiopathic Parkinson's Disease
A study testing biofeedback therapy in people with Idiopathic Parkinson's Disease and Constipation, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The aims of the investigators' study are to characterize the nature of constipation in idiopathic Parkinson's disease (IPD) and to evaluate the usefulness of biofeedback therapy in constipated IPD patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Idiopathic Parkinson's Disease, Constipation
- What is being tested?
- biofeedback therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2007to Aug 2008
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Idiopathic Parkinson's disease
Who cannot join
- Secondary Parkinson's disease
Trial locations and contacts
1 site in 1 country.
About this study
The aims of the investigators' study are to characterize the nature of constipation in idiopathic Parkinson's disease (IPD) and to evaluate the usefulness of biofeedback therapy in constipated IPD patients.
Read the detailed description
The medical treatment of idiopathic Parkinson's disease (IPD) alleviates constipation symptoms due to the restoration of autonomic dysfunction. However, additional laxatives are usually needed in these patients. Other suppository treatments included stool softeners, dopamine-receptor agonists, botulinum toxins, and prokinetic medications such as tegaserod. Biofeedback therapy (BFT) has been the gold standard for functional constipation with dyssynergic defecation or rectal hyposensitivity. However, researchers have not tried to evaluate its usefulness in constipated IPD patients up to now. The aims of our study are to characterize the nature of constipation in IPD and to evaluate the usefulness of BFT in constipated IPD patients.
- Conditions
- Idiopathic Parkinson's Disease, Constipation
- Being tested
- biofeedback therapy
- Keywords
- Biofeedback, constipation, Parkinson's disease
- Medical subject headings
- Parkinson Disease, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biofeedback therapyOther
Also called perianal sensor (Perry, Elan, SRS Medical Systems, Redmond, WA, USA), biofeedback PC equipment (Orion, Platinum, SRS Medical Systems, Inc., Redmond, WA, USA).
biofeedback therapy was applied using the surface electromyography (EMG) method with a perianal sensor (Perry, Elan, SRS Medical Systems, Redmond, WA, USA) and biofeedback PC equipment (Orion, Platinum, SRS Medical Systems, Inc., Redmond, WA, USA).
| Study group | Role | What they receive |
|---|---|---|
| biofeedback | Experimental | Not described Receives: Other: biofeedback therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effectiveness of biofeedback therapy in Parkinson's disease
Measured: usually six sessions per one biofeedback for 3 months
Secondary outcomes (1)
to evaluate the constipation type in Parkinson's disease
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2009 (estimated)
- Study startJan 2007
- Primary completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Kee Wook Jung, M.D., Principal investigator, Asan Digestive Disease Research Institute, Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00869830
- Sponsor's protocol ID
- BFT in IPD
- Status last verified
- Mar 2009
- First submitted
- 25 Mar 2009
- Last updated
- 26 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Biofeedback Treatment in Constipated Patients With Idiopathic Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00869830
- Acronym / sponsor ID
- BFT in IPD
- Conditions
- Idiopathic Parkinson's Disease, Constipation
- Keywords
- Biofeedback, constipation, Parkinson's disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Aug 2008 (actual)
- First posted
- 26 Mar 2009 (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 aims of the investigators' study are to characterize the nature of constipation in idiopathic Parkinson's disease (IPD) and to evaluate the usefulness of biofeedback therapy in constipated IPD patients.
Detailed description
The medical treatment of idiopathic Parkinson's disease (IPD) alleviates constipation symptoms due to the restoration of autonomic dysfunction. However, additional laxatives are usually needed in these patients. Other suppository treatments included stool softeners, dopamine-receptor agonists, botulinum toxins, and prokinetic medications such as tegaserod. Biofeedback therapy (BFT) has been the gold standard for functional constipation with dyssynergic defecation or rectal hyposensitivity. However, researchers have not tried to evaluate its usefulness in constipated IPD patients up to now. The aims of our study are to characterize the nature of constipation in IPD and to evaluate the usefulness of BFT in constipated IPD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| biofeedback | Experimental | Other: biofeedback therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Idiopathic Parkinson's disease
Key exclusion criteria (1 listed)
- Secondary 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 |
|---|---|---|
| biofeedback therapyAlso: perianal sensor (Perry, Elan, SRS Medical Systems, Redmond, WA, USA), biofeedback PC equipment (Orion, Platinum, SRS Medical Systems, Inc., Redmond, WA, USA).biofeedback therapy was applied using the surface electromyography (EMG) method with a perianal sensor (Perry, Elan, SRS Medical Systems, Redmond, WA, USA) and biofeedback PC equipment (Orion, Platinum, SRS Medical Systems, Inc., Redmond, WA, USA). | Other | biofeedback |
Primary outcome
To evaluate the effectiveness of biofeedback therapy in Parkinson's disease
Time frame: usually six sessions per one biofeedback for 3 months
1 secondary outcome
to evaluate the constipation type in Parkinson's disease
Time frame: 3-6 months
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 26 Mar 2009.
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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.
Kee Wook Jung, M.D. principal investigator
Asan Digestive Disease Research Institute, Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biofeedback therapy in people with Idiopathic Parkinson's Disease and Constipation, run by Asan Medical Center at 1 site in South Korea.
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 26 Mar 2009. 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 South Korea. 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?
To evaluate the effectiveness of biofeedback therapy in Parkinson's disease (time frame: usually six sessions per one biofeedback for 3 months). 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 26 Mar 2009.