The Motor Network in Parkinson's Disease and Dystonia: Mechanisms of Therapy
Running, not enrolling · Not applicable
Conditions studied: Parkinson Disease, Dystonia
In brief
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.
Key facts
- Study ID
- NCT03582891
- Run by
- University of California, San Francisco
- People needed
- 25
- Starts
- 2018-10-01
- Expected to finish
- 2028-03-01
- Last updated by the study team
- 2026-06-11
Who can join
Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Parkinson's Disease:
- 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.
- Age 21-75 (for STN patients, minimum age is 25)
- Diagnosis of idiopathic PD with duration of motor symptoms for 4 years or greater
- Patient has undergone appropriate therapy with oral medications with inadequate relief as determined by a movement disorders neurologist, and has had stable doses of antiparkinsonian medications for 30 days prior to baseline assessment.
- UPDRS-III score off medication between 20 and 80 and an improvement of at least 30% in the baseline UPDRS-III on medication score, compared to the baseline off-medication score, and motor fluctuations with at least 2 hours per day of on time without dyskinesia or with non-bothersome dyskinesia.
- OR Patients with tremor-dominant PD (a tremor score of at least 2 on a UPDRS-III sub-score for tremor), treatment resistant, with significant functional disability despite maximal medical management
- Dystonia:
- 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.
- Age 21-75
- Diagnosis of Isolated dystonia, which may be focal cervical, segmental craniocervical, or generalized forms.
- Stable doses of anti-dystonia medications (such as trihexyphenydil, Baclofen, or clonazepam) for at least 30 days prior to baseline assessment
- For dystonia patients with craniofacial and cervical involvement, prior treatment with botulinum toxin with failure to adequately control dystonia symptoms.
You may not qualify if…
- Parkinson's Disease:
- 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
- Previous cranial surgery
- Drug or alcohol abuse
- Meets criteria for Parkinson's disease with mild cognitive impairment (PD-MCI). These criteria are: performance of more than two standard deviations below appropriate norms, for tests from two or more of these five cognitive domains: attention, executive function, language, memory, and visuospatial tests.
- Dystonia:
- 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
- Previous cranial surgery
- Drug or alcohol abuse
Where it is running
- University of California at San Francisco — San Francisco, California, United States
Full record on ClinicalTrials.gov
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