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New treatment option for Parkinson's Disease
Official title Deep Brain Stimulation Therapy in Movement Disorders
ClinicalTrials.gov ID: NCT02119611
What this study is testing
- What it's testing
- Background: \- In deep brain stimulation (DBS), a device called a neurostimulator is placed in the chest. It is attached to wires in parts of the brain that affect movement.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- To be eligible for entry into the study, candidates must meet all the following criteria:
- Be 18 years of age or older.
- Able to comply with study procedures and provide informed consent.
- Have a clinical diagnosis of idiopathic PD, primary dystonia, or ET:
- The diagnosis of idiopathic PD will be based on the UK Brain Bank Criteria, and confirmed by the Movement Disorders Neurologists in the NIH Parkinson...
You likely can't join if
- For those who have not had DBS: Candidates will be excluded if they meet any of the following criteria:
- Clinically significant medical disease that would increase the risk of developing pre- or postoperative complications, including but not limited to...
- Evidence of secondary or atypical parkinsonism/dystonia/tremor as suggested by:
- History of stroke, exposure to toxins, neuroleptics, or encephalitis
- Neurologic signs of upper motor neuron or cerebellar involvement, supranuclear gaze palsy, or multiple systems atrophy.
- MR-imaging with evidence indicative of secondary disease such as tumor, or stroke, which could cause the movement disorder.
See the full eligibility criteria
Who can join
- To be eligible for entry into the study, candidates must meet all the following criteria:
- Be 18 years of age or older.
- Able to comply with study procedures and provide informed consent.
- Have a clinical diagnosis of idiopathic PD, primary dystonia, or ET:
- The diagnosis of idiopathic PD will be based on the UK Brain Bank Criteria, and confirmed by the Movement Disorders Neurologists in the NIH Parkinson Clinic.
- The diagnosis of primary (generalized or segmental), hemidystonia, or cervical dystonia will be confirmed on clinical examination in the NIH Movement Disorders Clinic.
- The diagnosis of ET will be confirmed on clinical examination in the NIH Movement Disorders Clinic (the diagnosis of ET will be based on bilateral, largely symmetric postural or kinetic tremor involving hands and...
- a. History of appropriate response to dopaminergic medication, with at least a 30% improvement in motor UPDRS with L-DOPA by history or in-clinic testing, for the PD patients. OR b.Patients with tremor-dominant PD that...
- Unsatisfactory clinical response to maximal medical management (with trials of both higher and lower doses of drugs), including: For PD patients:
- good benefit from dopaminergic medication but associated with insufficient duration of action or unacceptable side-effects OR
- intractable disabling motor fluctuations (severe off periods, dyskinesias, or freezing spells) OR For ET and dystonia:
- intractable symptoms of ET or dystonia impacting at least 2 activities of daily living.
- Interested in being evaluated to undergo DBS, if indicated, to treat medically refractory movement disorder or
- Patients already implanted with DBS for continued management (Note: 4 and 5 can be met by historical report in patients who had DBS implanted outside the NIH)
What rules you out
- For those who have not had DBS: Candidates will be excluded if they meet any of the following criteria:
- Clinically significant medical disease that would increase the risk of developing pre- or postoperative complications, including but not limited to uncontrolled systemic hypertension with values above 170/100; unstable...
- Evidence of secondary or atypical parkinsonism/dystonia/tremor as suggested by:
- History of stroke, exposure to toxins, neuroleptics, or encephalitis
- Neurologic signs of upper motor neuron or cerebellar involvement, supranuclear gaze palsy, or multiple systems atrophy.
- MR-imaging with evidence indicative of secondary disease such as tumor, or stroke, which could cause the movement disorder.
- Dementia as evidenced by formal neuropsychological evaluation, Mattis Dementia Rating Scale (DRS-2) score, and clinical evaluations.
- Unable to complete cognitive assessments and testing necessary to adequately evaluate risks and benefits of surgery.
- Clinically signficiant or unstable psychiatric disorder such as severe depression or anxiety, which, in the opinion of the investigators would increase the risk of developing postoperative complications.
- Unable to undergo MR-imaging because of implanted pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent eye...
- Pregnant women.
- Otherwise not eligible for DBS surgery, for example known inability to undergo anesthesia For those who have had DBS: -Contra-indications for ongoing stimulation, such as intractable side effects of DBS despite...
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, 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, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, 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.