Combined Deep Brain Stimulation for Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT01485276|
Recruitment Status : Withdrawn
First Posted : December 5, 2011
Last Update Posted : November 15, 2019
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- Deep brain stimulation (DBS) in the subthalamic nucleus (STN) is an approved treatment for Parkinson s disease. It stimulates a part of the brain that helps control symptoms like tremor, stiffness, and slow movements. However, many people continue to have unsteadiness and slowness while walking, trouble swallowing, and speech problems even with STN DBS. Another type of DBS focuses on a part of the brain called the pedunculopontine nucleus (PPN). PPN DBS has improved walking in some people with Parkinson's disease. Researchers want to see if combining the two types of DBS may help control symptoms better than STN DBS alone.
- To see if PPN DBS can help walking, balance, speaking, and swallowing in those who already have STN DBS.
- To study how the DBS combination affects brain function.
- Individuals with Parkinson s disease who had STN DBS surgery at least 1 year ago, but still have difficulty walking, swallowing, and speaking.
- Participants will be screened with a physical exam and medical history. They will also have neurological tests and other tests to measure Parkinson s disease symptoms.
- This study requires eight visits over 1 year. One of the visits will be a 9- to 10-day admission to the NIH Clinical Center for DBS surgery.
- Participants will have PPN DBS surgery. The surgery will be done in two steps. In the first step, the leads will be placed in the brain. In the second step, 1 week later, the stimulator device will be placed in the chest or abdomen.
- One month after the surgery, participants will have a study visit to program the PPN DBS device to find settings that will improve walking and balance.
- Participants will have study visits 2, 3, 6, and 12 months after surgery. Each visit will be used to check the stimulators and make any adjustments needed to try to improve walking and balance or to lessen side effects. Participants will have tests of walking and balance, speech, and swallowing. Some tests will be done with different combinations of the stimulators on or off to see the effects of each set of stimulators.
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Procedure: DBS Surgery||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Bilateral Pedunculo-Pontine Nucleus (PPN) Deep Brain Stimulation for Patients With Parkinson Disease (PD) Who Have Persistent Gait Disturbance, Despite Bilateral Subthalamic Nucleus (STN) Deep Brain Stimulation|
|Study Start Date :||November 8, 2011|
|Actual Study Completion Date :||July 30, 2014|
- Change in the amount of time needed to complete a standardized timed up and go (TUG) study at 6 months post-surgery on stimulation
- TUG study at 1, 3 and 12 months post-surgery.
- UPDRS III score and UPDRS III points 27-30 at 1, 3, 6 and 12 months
- PDQ 31 questionnaire at 6 months
- Swallowing function at 6 moths
- Static and dynamic posturography parameters at 1, 3, 6 and 12 months on stimulation.
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|Ages Eligible for Study:||22 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
i. Greater than 22 years of age
ii. Successful bilateral STN DBS implants for at least 1 year
iii. At least 30% improvement in the motor UPDRS following STN therapy, by history and record review
iv. Improved UPDRS and self assessment questionnaire following STN DBS by at least 20%, by history and record review.
v. Good STN DBS placement assessed with imaging (CT scan, MRI or fused CT-MRI imaging)
vii. Persistent gait disturbance as ascertained by abnormal performance on the time-up-and-go test compared to age-matched controls as well as preoperative evaluation with posturography and quantitative gait assessment (values compared to normal age-matched controls) at least 30% difference from age-matched controls on either measure.
vii. Persistent speech and swallowing problems as measured by a minimum score of I in items 5 and 7 of the UPDRS
viii. Evaluation by an independent movement disorders specialist who will confirm gait disturbance in the presence of STN stimulation.
i. Pregnant or nursing women
ii. Cognitively impaired subjects as determined by pre-operative neuropsychology evaluation, including Mattis Dementia Rating Scale (DRS). Patients scoring below 70 on the Mattis DRS will be excluded.
iii. Depressed subjects as determined by the neuropsychology screen, including Beck Depression Inventory. Patients scoring above 20 on the Beck inventory will be excluded.
iv. Patients with uncontrolled co-existing medical conditions: uncontrolled systemic hypertension with values above 170/100; heart disease needing intervention; respiratory disease needing intervention; uncorrected coagulation abnormalities or need for therapeutic anticoagulation which cannot be interrupted; any condition that would render the patient unable to safely cooperate with the study tests as judged by the screening physician.
v. Patients with metal objects in their body that are not MRI compatible, excluding the previous STN DBS hardware
vi. Patients who have a history of seizures, require repeated magnetic resonance imaging (MRI) scans or have had a cranial neurosurgical procedure since receiving an STN implant.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01485276
|Principal Investigator:||Mark Hallett, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|
|Responsible Party:||National Institute of Neurological Disorders and Stroke (NINDS)|
|Other Study ID Numbers:||
|First Posted:||December 5, 2011 Key Record Dates|
|Last Update Posted:||November 15, 2019|
|Last Verified:||July 30, 2014|
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