The Motor Network in Parkinson's Disease and Dystonia: Mechanisms of Therapy (NCT03582891) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Motor Network in Parkinson's Disease and Dystonia: Mechanisms of Therapy
United States25 participantsStarted 2018-10-01
Plain-language summary
This is an exploratory pilot study to identify neural correlates of specific motor signs in Parkinson's disease (PD) and dystonia, using a novel totally implanted neural interface that senses brain activity as well as delivering therapeutic stimulation. Parkinson's disease and isolated dystonia patients will be implanted unilaterally or bilaterally with a totally internalized bidirectional neural interface, Medtronic Summit RC+S.
This study includes three populations: ten PD patients undergoing deep brain stimulation in the subthalamic nucleus (STN), ten PD patients with a globus pallidus (GPi) target and five dystonia patients. All groups will test a variety of strategies for feedback-controlled deep brain stimulation, and all patients will undergo a blinded, small pilot clinical trial of closed-loop stimulation for thirty days.
Who can participate
Age range
21 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Ability to give informed consent for the study
. Movement disorder symptoms that are sufficiently severe, in spite of best medical therapy, to warrant surgical implantation of deep brain stimulators according to standard clinical criteria
. Patient has requested surgical intervention with deep brain stimulation for their disorder
. No MR abnormalities that suggest an alternative diagnosis or contraindicate surgery
. Absence of significant cognitive impairment (score of 20 or greater on the Montreal Cognitive Assessment (MoCA),
. Signed informed consent
. Ability to comply with study follow-up visits for brain recording, testing of adaptive stimulation, and clinical assessment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing adaptive deep brain stimulation — which adjusts automatically — to standard open-loop stimulation that stays fixed; can you explain what that difference might mean for how my symptoms are managed day to day, and whether my current DBS setup could even work in this study?
2The trial is no longer enrolling new participants, so what does that mean for my ability to join, and are there similar adaptive DBS studies coming up that I should be watching for?
3The study is measuring things like sleepiness, attention speed, and mood alongside motor symptoms — does that suggest adaptive DBS might affect my alertness or emotional state in ways that standard stimulation doesn't, and is that something I should be concerned about?
4For Parkinson's patients the main goal is reducing the time spent with dyskinesia while still getting good 'on' time — based on my current pattern of 'on' and 'off' periods, do you think adaptive stimulation is something worth pursuing for me even outside a research setting?
5If I have dystonia, the trial is using the Burke-Fahn-Marsden scale and the Toronto Western Torticollis scale to measure improvement compared to before surgery — how do my current scores on those measures compare to the kinds of patients who tend to respond best to DBS??
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Duration of 'on' stimulation time without dyskinesia from motor diaries in adaptive compared to standard open loop stimulation. (Parkinson's disease patients)
Timeframe: Comparison will use data from the testing of open and closed-loop stimulation during chronic adaptive DBS testing at home.
2
The Burke-Fahn-Marsden Dystonia Rating Scale-Movement aDBS testing compared to pre-operative baseline(Dystonia Patients)
Timeframe: Comparison will use data from the testing of open and closed-loop stimulation during chronic adaptive DBS testing at home.
3
Toronto Western Spasmodic Torticollis Rating Scale during aDBS testing compared to pre-operative baseline (Dystonia Patients)
Timeframe: Comparison will use data from the testing of open and closed-loop stimulation during chronic adaptive DBS testing at home.
4
Karolinska Sleepiness Scale
Timeframe: Through study completion, up to 4 years
5
Psychomotor vigilance task (PVT)
Timeframe: Through study completion, up to 4 years
6
Positive and Negative Affect Schedule (PANAS-SF)
Timeframe: Through study completion, up to 4 years
. Coagulopathy, anticoagulant medications, uncontrolled hypertension, history of seizures, heart disease, or other medical conditions considered to place the patient at elevated risk for surgical complications
. Evidence of a psychogenic movement disorder: Motor symptoms that remit with suggestion or "while unobserved", symptoms that are inconsistent over time or incongruent with clinical condition, plus other manifestation such as "false" signs, multiple somatizations, or obvious psychiatric disturbance.
. Pregnancy: all women of child bearing potential will have a negative urine pregnancy test prior to undergoing their surgical procedure.
. Significant untreated depression (BDI-II score \>20) History of suicidal attempt or active suicidal ideation (Yes to #2-5 on C-SSRS)
. Any personality or mood symptoms that study personnel believe will interfere with study requirements.
. Subjects who require ECT, rTMS or diathermy
. Implanted stimulation systems such as; cochlear implant, pacemaker, defibrillator, neurostimulator or metallic implant