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New treatment option for Parkinson Disease
Official title Globus Pallidus Stimulation to Treat Insomnia
ClinicalTrials.gov ID: NCT04116996
What this study is testing
- What it's testing
- Researchers are to determine if turning on an additional unilateral DBS (deep brain stimulation) electrode with stimulation to the globus pallidus externa (GPe) region of the brain will improve insomnia (sleep).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- 40-80 years of age
- Symptomatic with Parkinsonism for 7-20 years
- Severe insomnia based on ISI score
You likely can't join if
- Clinically significant dementia (MMSE \<23)
- Hoehn \& Yahr [Hoehn, 1967 #1839] stage I or V disease
- Other significant neurological or psychiatric disease
- Previous pallidotomy or thalamotomy
- Previous placement of other implantable devices
- Secondary parkinsonism (non-idiopathic parkinsonism)
See the full eligibility criteria
- 40-80 years of age
- Symptomatic with Parkinsonism for 7-20 years
- Severe insomnia based on ISI score
- Clinically significant dementia (MMSE \<23)
- Hoehn \& Yahr [Hoehn, 1967 #1839] stage I or V disease
- Other significant neurological or psychiatric disease
- Previous pallidotomy or thalamotomy
- Previous placement of other implantable devices
- Secondary parkinsonism (non-idiopathic parkinsonism)
- Inability to travel to Jacksonville for post-operative study visits
- Severe sleep apnea
- Insomnia due to pain or untreated mood disorder
- Contraindications to 3T MRI
- Circadian rhythm sleep disorders.
- Current use of hypnotics
The study team makes the final eligibility decision.
Where it's taking place
- Jacksonville, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jacksonville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.