Clinical trial 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
- The study aims to learn whether DBS is safe and how it affects movement and thinking in people with Parkinson's disease after the device is implanted.
- Who it's for
- Adults age 18 or older who have Parkinson's disease.
- What's involved
- Participants will have screening tests (medical history, blood and urine tests, MRI, heart monitoring, chest X‑ray, and cognitive tests). After they receive DBS surgery (which is not part of the study), doctors will turn on the device, adjust its settings, and perform movement and thinking tests at scheduled visits.
- Time commitment
- Follow‑up lasts about two years with visits at 3‑4 weeks after surgery, monthly for three months, then every three months for the first year and every six months during the second year.
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
- Be 18 years of age or older.
- Able to comply with study procedures and provide informed consent.
- 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...
- The diagnosis of primary (generalized or segmental), hemidystonia, or cervical dystonia will be confirmed on clinical examination in the NIH Movement...
- 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...
You likely can't join if
- Clinically significant medical disease that would increase the risk of developing pre- or postoperative complications, including but not limited to...
- 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.
See the full eligibility criteria
Who can join
- Be 18 years of age or older.
- Able to comply with study procedures and provide informed consent.
- 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.
- good benefit from dopaminergic medication but associated with insufficient duration of action or unacceptable side-effects OR
- 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
- 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
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Bethesda, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.