Combined Deep Brain Stimulation for Parkinson's Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01485276|
Recruitment Status : Withdrawn
First Posted : December 5, 2011
Last Update Posted : February 19, 2018
- 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|
Show Detailed Description
|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|
|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.
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)|