Parkinson's DiseaseNCT01169324
Effect of Deep Brain Stimulation (DBS) on Sleep Architecture in Patients With Movement Disorders
A study testing Alteration of DBS stimulator settings in people with Parkinson's Disease and Tremor, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this prospective, participant-blinded trial is to determine the changes in sleep architecture in a cohort of subjects who have undergone deep brain stimulation (DBS) surgery for treatment of movement disorders such as moderate to advanced Parkinson's disease (PD), tremor, or dystonia. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Parkinson's Disease, Tremor, Dystonia
- What is being tested?
- Alteration of DBS stimulator settings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2010to 11 Dec 2015
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prior DBS surgery for treatment of movement disorders such as PD, tremor, or dystonia.
- Stable DBS stimulator settings and medication regimen for at least 6 weeks prior to the sleep studies.
- Sleep dysfunction as measured by the Pittsburgh Sleep Quality Index (PSQI) (score >5) at the subject's baseline pre-surgical evaluation.
Who cannot join
- Known narcolepsy
- Other previous surgical treatment of Parkinson's disease, tremor, or dystonia (with the exception of DBS) including pallidotomy, thalamotomy, or gene therapy procedures.
- Untreated obstructive sleep apnea. If obstructive sleep apnea is discovered during the first sleep study, the subject will be removed from the study. After they have been treated for at least 6 weeks with CPAP, they can re-start the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Effect of DBS on Sleep Architecture in Patients With Movement Disorders.
The purpose of this prospective, participant-blinded trial is to determine the changes in sleep architecture in a cohort of subjects who have undergone deep brain stimulation (DBS) surgery for treatment of movement disorders such as moderate to advanced Parkinson's disease (PD), tremor, or dystonia. Our preliminary observational data suggest that unilateral subthalamic nucleus (STN) DBS improves subjective sleep quality in PD patients 6 months after the procedure. The cause of this improvement in sleep quality is unknown, and this study proposes the use of polysomnography (PSG) to test whether the improvement in sleep is independent of improvement in night-time mobility associated with DBS treatment of the motor symptoms of PD, tremor, or dystonia.
- Conditions
- Parkinson's Disease, Tremor, Dystonia
- Being tested
- Alteration of DBS stimulator settings
- Keywords
- Parkinson's disease, Tremor, Dystonia, DBS, Sleep
- Medical subject headings
- Parkinson Disease, Tremor, Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alteration of DBS stimulator settingsOther
Alteration of DBS stimulator settings
| Study group | Role | What they receive |
|---|---|---|
| DBS on | Experimental | baseline settings Receives: Other: Alteration of DBS stimulator settings |
| DBS off | No intervention | DBS off |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Efficiency
This is the percentage of time the subject is in bed when he/she is actually asleep.
Measured: 1 month
Secondary outcomes (3)
Wake after sleep onset (WASO)
This is a measurement of the amount of time during polysomnography recording that the subject is awake after their initial sleep onset.
Measured: 1 month
Total Sleep Time
Measured: 1 month
Two timed motor tasks
- The subject will tap index finger between 2 points 30 cm apart on the table for 10 seconds.
- The subject will be timed as they rise from a chair, walk 7 meters, return to the chair, and sit down.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2010 (estimated)
- Study start15 Jul 2010
- Primary completion11 Dec 2015
- Study completion11 Dec 2015
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 Alabama at BirminghamThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Amara, MD, University of Alabama at Birmingham
- Investigators
- Amy W Amara, MD, phD, Principal investigator, UAB Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01169324
- Sponsor's protocol ID
- F100528004
- Status last verified
- Apr 2019
- First submitted
- 2 Jul 2010
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of DBS on Sleep Architecture in Patients With Movement Disorders.
- ClinicalTrials.gov ID
- NCT01169324
- Acronym / sponsor ID
- F100528004
- Conditions
- Parkinson's Disease, Tremor, Dystonia
- Keywords
- Parkinson's disease, Tremor, Dystonia, DBS, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 15 Jul 2010 (actual)
- Primary completion
- 11 Dec 2015 (actual)
- Study completion
- 11 Dec 2015 (actual)
- First posted
- 26 Jul 2010 (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 purpose of this prospective, participant-blinded trial is to determine the changes in sleep architecture in a cohort of subjects who have undergone deep brain stimulation (DBS) surgery for treatment of movement disorders such as moderate to advanced Parkinson's disease (PD), tremor, or dystonia. Our preliminary observational data suggest that unilateral subthalamic nucleus (STN) DBS improves subjective sleep quality in PD patients 6 months after the procedure. The cause of this improvement in sleep quality is unknown, and this study proposes the use of polysomnography (PSG) to test whether the improvement in sleep is independent of improvement in night-time mobility associated with DBS treatment of the motor symptoms of PD, tremor, or dystonia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DBS on | Experimental | Other: Alteration of DBS stimulator settingsbaseline settings |
| DBS off | No intervention | –DBS off |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Prior DBS surgery for treatment of movement disorders such as PD, tremor, or dystonia.
- Stable DBS stimulator settings and medication regimen for at least 6 weeks prior to the sleep studies.
- Sleep dysfunction as measured by the Pittsburgh Sleep Quality Index (PSQI) (score >5) at the subject's baseline pre-surgical evaluation.
Key exclusion criteria (3 listed)
- Known narcolepsy
- Other previous surgical treatment of Parkinson's disease, tremor, or dystonia (with the exception of DBS) including pallidotomy, thalamotomy, or gene therapy procedures.
- Untreated obstructive sleep apnea. If obstructive sleep apnea is discovered during the first sleep study, the subject will be removed from the study. After they have been treated for at least 6 weeks with CPAP, they can re-start the study.
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 |
|---|---|---|
| Alteration of DBS stimulator settingsAlteration of DBS stimulator settings | Other | DBS on |
Primary outcome
Sleep Efficiency
Time frame: 1 month
This is the percentage of time the subject is in bed when he/she is actually asleep.
3 secondary outcomes
Wake after sleep onset (WASO)
Time frame: 1 month
Total Sleep Time
Time frame: 1 month
Two timed motor tasks
Time frame: 1 month
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 Apr 2019.
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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.
Amy W Amara, MD, phD principal investigator
UAB Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alteration of DBS stimulator settings in people with Parkinson's Disease and Tremor, run by University of Alabama at Birmingham 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 3 inclusion and 3 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 Apr 2019. 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?
Sleep Efficiency (time frame: 1 month). 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 Apr 2019.