Mapping Mood in the Subthalamic Nucleus in PD
What is the title of the study?
Mapping Mood in the Subthalamic Nucleus in PD (Mood-D Study)
What is the purpose of the study?
Depression and anxiety are common in individuals with Parkinson’s disease (PD). Deep Brain Stimulation in the subthalamic nucleus (STN DBS) provides effective treatment for the motor (movement) symptoms associated with PD; however its effect on current or future depression or anxiety is not fully understood. Some studies have reported that STN DBS can have effects on mood, which may be due to the location of the stimulators within or around the STN. This study will provide much needed information on mood complications in PD. It is hoped that the results will help identify and treat individuals with PD most at risk for depression or anxiety.
Who is needed?
We are looking for individuals who have been diagnosed with Parkinson Disease. We will have two groups of participants: and those who have Parkinson’s as well as the Deep Brain Stimulators (Group 1) and those who have Parkinson’s but do not have the Deep Brain Stimulators (Group 2).
What is involved if I participate?
Initial Interview Session:
All participants will be asked to take part in an initial interview session at the start of the study. This interview session will include questionnaires about mood and behavior, quality of life, cognitive testing and standard neurological physical exams. This initial visit does not involve being off your regular PD medications or changing the stimulator settings. If you have PD, you will continue to take your PD medication, and if you have stimulators, the settings will have been previously set by your physician.
STN DBS participants only:
1-Contact Group: The testing day will occur within approximately two weeks of the Interview Day. If you are included in this group, you will be asked to refrain from all PD medications overnight. You will undergo one Contact Manipulation Day in which your stimulators will be set to the following conditions: both sides OFF, both sides ON, left STN contact ON and right STN contact ON. Your stimulators will be turned back to regular settings at the end of the study day.
2-Contact Group: The testing days will occur within approximately two weeks of the Interview Day and one week of each other. If you are included in this group, you will be asked to refrain from all PD medications overnight. You will undergo two Contact Manipulation Days in which your stimulators will be set to the following conditions: both sides ON, both sides OFF, location #1 ON, location #2 ON. Your stimulators will be turned back to regular settings at the end of the study day.
In order to help determine study eligibility, a type of brain picture will be taken with a computed tomographic (CT) scanner. The CT scanner takes an X-ray of the head that will help precisely identify where the stimulators are. You will lie on a table and your head will be positioned in the middle of a large, doughnut-shaped scanner ring. Before starting the scan, it is important that we turn your stimulator(s) off. After the scan, we will turn your stimulator(s) back on again. Once the scan is begun, it is very important that you lie still, since movement will ruin the pictures of your brain. You are welcome to take a nap during the scan. The CT scan will take about 10 minutes to complete.
Follow-up: At 6 months, 12 months and 24 months after participation, all participants will be asked to participate in a follow-up interview session which includes many of the same measures at the initial interview session. The 6 month interview will consist of a phone call and a mailer of self-administered measures. These measures should take less than one hour to complete. The 12 and 24 month interviews consist of a visit to our lab and may take up to four hours. These visits do not involve being off PD medication or changing the stimulator settings. You will be on your regular PD medications, and if you have stimulators, they will have been returned to their optimal settings.
Below is a table that summarizes participation for each group:
|1-Contact STN DBS Group||2-Contact STN DBS Group||PD Control Group|
|Interview Session||Interview Session||Interview Session|
|Contact Manupulation (1 day)||Contact Manipulation (2 days)|
|Follow-up 6, 12, 24 months||Follow-up 6, 12, 24 months||Follow-up 6, 12, 24 months|
Your time involved in the study depends upon the group to which you belong. If you are in the PD Control Group, your participation will involve only interviews which will occur at the beginning of the study and then again at 6, 12 and 24 months. These interviews may take up to four hours. Your participation in the study may last approximately 16 hours over a 2 year period.
If you are in the 1-contact STN DBS Group, your participation will involve interviews which will occur at the beginning of the study and then again at 6, 12 and 24 months. These interviews may take from one to four hours. You will also be asked to participate in one manipulation testing day which may last up to six hours. Your participation in the study may last approximately 22 hours over a two year period.
If you are in the 2-contact STN DBS Group, your participation will involve interviews which will occur at the beginning of the study and then again at 6, 12 and 24 months. These interviews may take from one to four hours. You will also be asked to participate in two manipulation testing days which may last up to six hours each. Your participation in the study may last approximately 28 hours over a two year period.
Likely: The risks of the being off your PD medication overnight include an increase in PD symptoms such as stiffness, tremor, slowness and/or imbalance. The risks of having your stimulator settings changed several times include an increase in PD symptoms such as stiffness, tremor, slowness and/or imbalance. Having your stimulator settings changed for a short period of time does not present any long term risks. Also, you may experience some common side effects of stimulation such as tingling sensations and impairment of muscle movement.
Less Likely: You may experience perceived difficulty with speech, difficulty in word finding, a general feeling of discomfort or uneasiness, changes in mood.
Rare: You may experience involuntary muscle spasms and twisting of the limbs, blurred vision or double vision, eye twitching, discomfort, embarrassment or frustration when asked certain questions during the interview session.
A potential risk of participating in this study is that confidential information about you may be accidentally disclosed. We will use our best efforts to keep the information about you secure, and we think the risk of accidental disclosure is very small. Please be aware that if you are at risk of harming yourself or others, the investigator would be responsible for reporting this information to authorities. The investigator is willing to discuss any concerns you might have about these risks and discomforts.
You also may experience a malfunction of worn or implanted electronic medical devices.*
*If you wear or have electronic medical devices implanted such as a pacemaker or a drug pump, please make sure you tell your study doctors and research staff. It was recently reported by the FDA that the CT scan may cause a malfunction of electronic medical devices.” It is possible that you could experience shock-like sensations or other side effects during the CT. This chance is very slight and minimized further by turning off your stimulators while the CT is performed. If practical, you will be asked to do one or more of the following: move external devices out of the scan range or patients with neurostimulators will be asked to shut off the device temporarily while the scan is performed. In order to minimize x-ray exposure to the implanted or externally worn electronic medical device we will use the lowest possible x-ray tube current consistent with obtaining the required image quality and make sure that the x-ray beam does not dwell over the device for more than a few seconds. You may experience all or some of the risks listed above. There may also be unknown risks. The PI will answer any questions you have about these risks.
Depending on your PD symptoms, it could be dangerous to drive while “off” of your PD medications. We will work with you to arrange transportation to and from our center on the day(s) of the study. You should be able to resume driving when your medications have alleviated the symptoms of being off the medication.
Participants will receive $30.00 for each interview session and $50.00 for each contact manipulation session. You will also be reimbursed for travel to and from the study at the federally recommended rate. In the event that you cannot drive arrangements for transportation can be made for you.
Who is the Principal Investigator?
Tamara Hershey, Ph.D.
Where will the study take place?
Washington University School of Medicine
Study Coordinator: Samantha Blankenship, MSW
Mailing Address: Washington University Medical School
660 S. Euclid Ave
St. Louis, MO 63110
Telephone: (314) 362-6514
E-mail Address: firstname.lastname@example.org